Journal of Hand Therapy 26 (2013) 191e201

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Journal of Hand Therapy

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CREDIT ARTICLE #269.

Scientic/Clinical Article

Effectiveness of cast immobilization in comparison to the gold-standard

self-removal orthotic intervention for closed mallet ngers: A randomized
clinical trial
Silvio Tocco BSc a, *, g, Paolo Boccolari BSc b, Antonio Landi MD c, Chiara Leonelli BSc d, g,
Catia Mercanti BSc b, Francesco Pogliacomi MD e, Silvana Sartini MD b, Lucia Zingarello BSc b,
Bernadette Nedelec PhD f
a

Studio Terapico Kaiser, Via Trento 15/A, 43100 Parma, Italy

Hand Rehabilitation Unit, Policlinico of Modena, Modena, Italy
c
Hand Surgery and Microsurgery Unit, Policlinico of Modena, Modena, Italy
d
Vignola Hospital, Modena, Italy
e
Section of Orthopedic, Traumatology and Functional Rehabilitation, Department of Surgical Sciences, University of Parma, Parma Hospital, Parma, Italy
f
School of Physical and Occupational Therapy, McGill University, Montral, Qubec, Canada
b

a r t i c l e i n f o

a b s t r a c t

Article history:
Received 3 November 2012
Received in revised form
5 January 2013
Accepted 21 January 2013
Available online 27 February 2013

Study design: Randomized clinical trial.

Introduction: Although orthotic immobilization has become the preferable treatment choice for closed
mallet injuries, it is unclear whether orthosis self-removal has an impact on the nal outcome.
Purpose: To evaluate the treatment efcacy of cast immobilization of closed mallet ngers using
Quickcast (QC) compared to a removable, lever-type thermoplastic orthosis (LTTP).
Methods: 57 subjects were randomized in 2 groups. DIPj extensor lag and the Gaberman success scale
were used as primary outcomes.
Results: LTTP subjects resulted in greater extensor lag than QC subjects (x 5 ; p 0.05) at 12 weeks
from baseline, and high edema and older age negatively affected DIPj extensor lag. No other differences
were found between groups.
Conclusion: Cast immobilization seems to be slightly more effective than the traditional approach
probably for its greater capacity to reduce edema.
Level of evidence: 1B.
2013 Hanley & Belfus, an imprint of Elsevier Inc. All rights reserved.

Keywords:
Mallet
RCT
Quickcast
Conservative
Treatment

Introduction
Extensor terminal tendon laceration or rupture in the long
ngers of the hand is a frequent hand injury seen in emergency
care.1e4 Multiple different colloquial terms have been used in the
past4,5 but this injury is most often referred to as a mallet nger.
This injury most frequently occurs while performing domestic
tasks (e.g., tucking in bed sheets or pulling up socks),6 sport
activities (e.g., high velocity impact with a ball or an opponent), or
work-related tasks (e.g., crush, blow to the nger).5,7
N.B. No grants or nancial assistance was used for this study.
* Corresponding author. Tel.: 39 338 7090316; fax: 39 0521 1880298.
E-mail address: silvio.tocco@libero.it (S. Tocco).
g
Afliated to the Policlinico of Modena at the time of the study.

A myriad of treatment approaches can be found in the literature.8 Both surgical and conservative intervention protocols have
been proposed. However, conservative treatment through orthotic
immobilization has gained favorable recognition over surgical
approaches for closed tendinous or bony mallet injuries (Type I).9,10
Conservative orthotic treatment consists of immobilizing the
distal interphalangeal joint (DIPj) for a number of weeks in a position of slight hyperextension,11,12 avoiding blanching of the dorsal
skin.13 A literature review14 reported that orthosis selection and
prescribed wearing schedules vary considerably amongst hand
therapists and there is limited information describing the postimmobilization phase of the rehabilitation process.11 Zolotov and
colleagues15 described their regime for reducing the orthosis wear
time but no other citations can be found in this regard. In addition,
a Cochrane meta-analysis5 concluded that no one orthosis model is

0894-1130/$ e see front matter 2013 Hanley & Belfus, an imprint of Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.jht.2013.01.004

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S. Tocco et al. / Journal of Hand Therapy 26 (2013) 191e201

superior to another. A recent Delphi survey conrmed this

nding.11 Thus, it is still unclear which aspects of the conservative
treatment have an important impact on the nal outcome for this
injury.
The main goal of orthotic intervention for a mallet nger injury
is to closely approximate the extensor tendon ends so that primary
healing of the tendon can occur.3 The proximal interphalangeal
joint (PIPj) is allowed to freely mobilize, which in turn releases
tension at the laceration site of the terminal tendon through volar
migration of the lateral bands when exed.11,12 A common drawback of all orthotic models is that they produce various degrees of
skin maceration and need to be removed frequently during the
immobilization phase to avoid complications.11,13,16 Usually
patients are cautioned on their rst visit to avoid exing the DIPj
during the home-based skin cleansing procedures by resting the
injured digit on a at table top or through tip-to-tip pinching with
the ipsilateral thumb.17 The ability of patients to correctly maintain
the DIPj at or beyond full extension during orthosis removal has not
been well documented, nor has the impact of their ability to adhere
to this positioning prescription been tested. Groth and Wilder18 did
examine patients with mallet nger injuries self-reported performance of home exercise and activity programs and their attendance at therapy appointments and found that poor outcomes were
more common among patients who did not adhere to therapy
prescriptions and missed multiple appointments.
Purpose of the study
We hypothesized that conservative treatment outcomes would
improve if patients were not required to remove their orthosis for
cleansing during the immobilization period. To answer this question, the ideal orthotic material needs to offer: rigidity for constant
immobility, aeration to avoid maceration and allow for use of the
involved hand. At the time of the present clinical trial, Quickcast
nishing tape satised these criteria. Brief descriptions of this
material can be found in the literature.19e24
Hence, the purpose of this study was to evaluate the treatment
efcacy of full-time immobilization of Type 1 mallet nger injuries
using Quickcast compared to a custom-fabricated, removable, low
temperature thermoplastic, lever-type orthosis.
Materials and methods
Trial design and subjects
A single center, assessor-blinded, study was performed with
subjects being randomized to either full-time immobilization in
a low temperature thermoplastic orthosis (Fig. 1) or a Quickcast
orthosis (Fig. 2) that was worn 24 h/day. This study was approved
by the hospital Ethics Committee. Subjects were not stratied

according to age, sex, DIPj extensor lag, delay from presentation

and type of injury since there is controversy in the literature with
respect to their association with outcomes.7,11,14,25,26
Eligible subjects had to be older than 18 years, present with
a minimum of 20 DIPj active extensor lag that was correctable
passively, with an injury onset of less than 90 days prior to
commencing the study and who signed an informed consent. To
minimize study drop-outs, patients living outside a 75 km radius of
the Hand Center were excluded. Patients suffering from osteoarthritis and those presenting with a mallet thumb were also
excluded. Although recent studies have demonstrated good
outcomes with conservative treatment for large bony mallet
injuries27,28 it remains controversial.29 Thus fragment size was
assessed through plain radiography by the referring surgeon and
the primary author (ST) and those with an intra-articular fragment
greater than 1/3 of the joint surface were excluded. In addition,
patients with multiple ipsilateral hand injuries other than Type 1
mallet injury or those having sustained past injuries or surgeries to
the involved digit or contralateral digit were excluded.
Intervention protocol and orthotic design
Subjects were randomly assigned to receive a custom-fabricated
low temperature thermoplastic, lever-type orthosis (LTTP Group) to
be worn at all times or to receive custom-fabricated Quickcast
(Homecraft-Rolyan, Nottingham, UK) orthosis (QC Group). The LTTP
orthosis covered the distal phalanx circumferentially and extended
dorsally to the middle phalanx. It was held in place with 1/2 inch
paper adhesive tape (Micropore Tape, 3M Industries, Minnesota,
USA) applied at the most proximal portion of the orthosis avoiding
unnecessary tape thickness which could hinder proximal interphalangeal joint (PIPj) exion (Fig. 1). Ort Classic (Ort Industries, Wijnegem, Belgium) 2 mm thickness, beige, micro-perforated
thermoplastic was used. The QC orthosis covered both the distal
and middle phalanges circumferentially and was also held in place
with 1/2 inch paper adhesive tape applied at the most proximal
portion of the orthosis avoiding unnecessary tape thickness which
could hinder PIPj exion (Fig. 2). The application technique for the
nishing tape was previously described by Schultz-Johnson.19
In order to answer the study question, all subjects needed to be
immobilized for the same period of time, based upon the acuity of
their injury. According to the Indiana Hand Rehabilitation Center
protocols (Indianapolis, USA), which are based on a comprehensive
literature review, 6 weeks of immobilization is required for acute
injuries and 8 weeks for chronic injuries (dened as 22 days postinjury) to obtain spontaneous tendon repair.30 Recently, other
studies have also based their treatment protocols on these guidelines.27,28,31e33
Any immobilization device applied in the emergency room was
removed at study admission and the subjects were asked to ex

Fig. 1. Custom-made low temperature thermoplastic lever orthosis (LTTP Group).

S. Tocco et al. / Journal of Hand Therapy 26 (2013) 191e201

193

Fig. 2. Quickcast orthosis (QC Group).

and extend their ngers 3e4 times. Immediately after their rst
evaluation subjects received an orthosis based upon their group
allocation. The same immobilization position (DIPj at 0 or slight
hyperextension) was used for both groups,11 avoiding excessive
skin blanching dorsal to the joint.13 In order to avoid treatment bias
the LTTP orthoses were always fabricated by the same therapist
(PB) as were the QC orthoses (ST). All one to one instructions were
provided and questions were answered by the same therapist (ST)
throughout the study.
The wear and care instructions differed between groups. For the
LTTP subjects the technique described by Richards and colleagues17
was recommended. This involved removal of their orthosis on
a daily bases for skin care. When the orthosis was removed they
were instructed to support the DIPj in hyperextension by resting it
on a at surface such as a table top or counter top. While the
orthosis was off, the nger and orthosis was to be cleaned with an
alcohol swab and the nger dried with a hair dryer, prior to redonning the orthosis. All instructions were provided in verbal
and written form and practice attempts were performed. Subjects
were asked to document the frequency of orthotic removal.
Conversely, the QC group was instructed to abstain from cast
removal at any time and to contact the treatment provider immediately if their cast accidentally came off. All subjects were
instructed to use their hand freely for all activities of daily living
and work/sport activities without ever removing their orthosis.
Three to four weeks after immobilization all subjects returned
for a follow-up appointment (FU1). Cast removal and re-fabrication
was necessary for the QC group to allow for skin evaluation and
accurate edema measurements. During the fabrication and evaluation process the DIPj was consistently maintained in slight
hyperextension.
In order to provide a consistent treatment approach to all
subjects, at 6e8 weeks (FU2) the full-time immobilization period
was ended. Hence, prolonged immobilization was not recommended for those subjects with extension lags following the
immobilization period, despite this being suggested in the literature such as in the Indiana protocol.30 At this time, an LTTP orthosis
was fabricated for the subjects in the QC group, identical to the
design used for the LTTP group at baseline and all instructions and
wearing regimes were identical for both groups from this point
forward. Subjects were instructed to remove their orthosis 6e8
times per day to perform a home-based exercise program in
addition to the previously described skin and orthosis hygiene
routine. The home based exercise program consisted of passive
metacarpal phalangeal (MCP) exion blocking while actively
extending the PIPj and DIPj for 5 s. This maneuver was repeated 10
times before the orthosis was reapplied.
At seven to 9 weeks post-immobilization (FU3) active sting
exercises were added by alternating them with the previously
described interphalangeal extension.
At eight to ten weeks (FU4) orthotic wear was discontinued
during the day and only continued at night.
At ten to twelve weeks (FU5) orthotic wear was discontinued
entirely but the home-based exercises were continued.

At twelve to fourteen weeks (FU6) the subjects were instructed

to use their hand normally in daily activities. Throughout the study
period the subjects were prohibited from performing any passive
DIPj exion.
The subjects were re-evaluated for a nal time at 24e28 weeks
(FU7) post-immobilization.
Outcomes
There were two primary outcome measures in this study were
DIPj extensor lag and a dichotomous success rating.
Range of motion was measured with a at Baseline 15 cm metal
arm goniometer (Fabrication Enterprises Inc., NY, USA) and reported
in degrees. As per the American Society of Hand Therapist
(ASHT) recommendations,34 range-of-motion (ROM) was measured
dorsally. Measures were rounded to the nearest 5 since an error of
such magnitude is common with nger goniometers.34 Goniometers
used in this study were purchased just prior to beginning the trial
and free from imperfections.
Treatment was categorized as either successful or unsuccessful
based upon a modied version of the Gaberman and colleagues
scale35 (Table 1). To more precisely dene the treatment outcome
DIPj exion loss of this scale, in this study, it was dened as a 30
decit or greater in comparison to the unaffected side.
There were three secondary outcome categories; edema, hand
function and complications.
Edema
There are numerous techniques to measure nger edema but
most are time consuming, inappropriate for single ngers or unreliable.34 Although the psychometric properties of the Oval-8 Ring
Sizers (3-Point Products Inc., Maryland, USA) have not been reported in the literature they are clinically accepted as a consistent
method to measure nger edema. In this study, the Oval-8 Ring
Sizers, from smallest (1) to largest (15) rings (half sizes were also
used) were tted individually around the nger until the smallest
acceptable sizer reached and could not go beyond the mid-way
portion of the: 1) Middle phalanx (P2 measure), 2) DIPj (DIP
measure), and 3) Distal phalanx (P3 measure). Half-sizes were
recorded by adding 0.5 to the ring number. The difference between
the injured nger and its healthy counterpart was recorded. All three
measurements were highly correlated; therefore, only measurements taken at the mid-proximal phalanx were used for statistical
analysis since tendon rupture and healing occur in that region.
Hand function
Hand function included measures associated with subject
comfort and satisfaction and resulting hand impairments. These
Table 1
Mallet nger treatment success rating scale
Treatment success
Treatment failure

DIPj extensor lag  10

No DIPj stiffness or loss of exion (25 )
DIPj active extension decit  15
Associated DIPj stiffness or loss of exion (30 )

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S. Tocco et al. / Journal of Hand Therapy 26 (2013) 191e201

included discomfort associated with orthotic wear, subjective

esthetic evaluation of the orthosis, satisfaction with nal outcome,
DIPj exion stiffness and grip and tip-to-tip pinch strength.
Orthosis discomfort, orthosis esthetic appreciation and nal
outcome satisfaction were assessed with a Visual Analog Scale
(VAS), measured in centimeters (cm) with a solid ruler (0 being the
most positive and 10 being the most negative score, i.e., 0 no
discomfort/excellent aesthetics/excellent outcome satisfaction;
10 severe discomfort/poor aesthetics/poor outcome satisfaction).
These subjective measures were gathered to determine the
subjects perspective of comfort, aesthetics and overall satisfaction
with the two treatment approaches.
Grip and tip-to-tip pinch strength was evaluated with the E-Link
Dynamometer System (Biometrics Ltd, Gwent, UK). Grip and pinch
strength evaluations were conducted according to the ASHT standards.34 The instructions were translated and read to the subjects in
Italian by the evaluators. Although the psychometric characteristics
of the E-Link Dynamometer System have not been reported with
traumatic hand injuries a recent study has explored the reproducibility and practicality of this system for patients with rheumatoid and osteoarthritis.36 Calibrations of the E-Link System were
performed yearly at the data collection site by the hospital engineering department.
Complications
Based on the Cochrane Database review done by Handoll and
Vaghela,5 treatment complications of mallet injuries includes skin
ulceration beneath the orthosis and the development of a swanneck deformity. In this study, a four-point scale (Table 2) was
used to evaluate skin maceration. The presence of PIPj hyperextension beyond 10 and a DIPj extensor lag of 10 or more were
considered a swan-neck deformity in this study. For either
outcome, no validated scale could be found in the literature.

Evaluators
The three independent evaluators (CL, CM and LZ) were kept
blind to treatment allocation. The subjects orthosis fabrication and
education occurred in an adjacent room. All evaluators had
a minimum of 3 years of experience in hand rehabilitation at the
beginning of the study. Nonetheless, competency training and
evaluation sessions were performed prior to and 3 months into the
study with non-study patients to verify evaluator consistency
throughout the study. The competency evaluation sessions
required each evaluator to assess edema, ROM and grip/pinch
strength on volunteer patients with various nger deformities (10
at the beginning of the study and 5 after 3 months). For edema
assessment, repeated measures were performed until all 3 evaluators results were within 1 ring sizers for P3, DIPj and P2 readings
for the same patient. For goniometry readings, repeated measures
were performed until all 3 evaluators results were within 5 of each
other for all 3 nger joints for the same patient. Data was not
collected at the time of the practice sessions, therefore post hoc
reliability analysis could not be performed. Edema and ROM
outcome measures were reported as a difference between the

Table 2
Skin maceration scale
Absent
Trace
Moderate
Severe

No sign of skin whitening

Whitening on 1/3 of skin area beneath splint and no skin
breakdown
Whitening on 2/3 of skin area beneath splint and no skin
breakdown
Supercial skin layer breakdown

affected joint or phalanx and its unaffected counterpart to minimize inter-rater bias and to exclude hyperextension or incomplete
extension tendencies in subjects. The values used in the statistical
analyses were therefore true deformities of the affected ngers.
Final grip and pinch strength measurements were reported as
percentage difference between the involved and uninvolved hand/
nger.
Subjects were always evaluated after their orthosis had been
removed by the treatment provider (ST). As a general rule, subjects
were always assessed by the same evaluator at each follow-up.
During the rst visit, the subjects were evaluated prior to
opening the group assignment envelope. Subjects were given the
subjective data collection questionnaire by the treatment provider
before the objective evaluation at each follow-up. They were asked
to provide spontaneous answers for all questions, reassuring them
that their answers would not have repercussions on the remaining
treatment program. Orthoses were fabricated only after the evaluation was completed, thus keeping the evaluators blind to the
group assignment.
Randomization and allocation mechanism
Subjects were randomly assigned using a computerized random
numbers table to assign subjects to the LTTP or QC group. The
allocation sequence was concealed from the rehabilitation physician (SS) who referred potential subjects, using the study inclusion/
exclusion criteria, to the treatment provider (ST). Sequentially
numbered, opaque, sealed envelopes were opened by the latter in
presence of the TP orthosis maker (PB), only after the enrolled
subjects completed all baseline assessments. All envelopes were
stored away from all researchers and delivered to the treatment
provider by the rehabilitation department secretary. The secretary
had no involvement in this study other than generating the allocation sequence, preparing and concealing the envelopes from the
authors, and delivering the envelopes.
Data analysis
Descriptive statistics were created for all variables using
frequency counts, and percentages for categorical variables.
Interval-scaled variables are described with mean and standard
deviation if the distribution of values showed evidence of being
normally distributed. If the distribution showed skewness, median
and range were used. Chi-square (c2) test was used for comparisons
on cross-classication tables. However, when at least one cell in
a cross-classication table had an expected value < 5, the Fishers
exact (FE) test was used. Comparisons of means were done with ttests for independent samples and comparisons of medians with
the Wilcoxon Rank Sum (WRS) test. p-values were adjusted for
multiple testing using the Holms method.37
DIPj extensor lag
In order to determine which variables contributed to the
development of a DIPj extensor lag a repeated measures regression
analysis was performed. The dependent variable was DIPj extensor
lag and the independent variables were: orthotic design (LTTP vs.
QC), time elapsed between follow up and baseline, edema
measured over the middle phalanx, age at the time of injury, time of
injury onset, type of injury (bony or tendinous), type of injury
mechanism (Fall/Crush or direct blow) and acuity of injury
( 21 days old vs.  22 days old). The correlation of the repeated
measures over time was modeled with an unstructured-type
correlation, i.e., no particular structure was assumed. Degrees of
freedom were adjusted using the KenwardeRoger correction.38 The
assumptions on the errors required for a regression analysis

S. Tocco et al. / Journal of Hand Therapy 26 (2013) 191e201

(randomness, normality, homoscedasticity) as well as the presence

of outliers were checked with a visual analysis of residuals.
All statistical hypothesis tests were two-sided and performed at
the 0.05 signicance level. All analyses were done using the SAS
software (SAS Institute Inc., Cary, NC).
Results
Seven follow-up (FU) sessions were scheduled throughout
the treatment process (Fig. 3). Subjects who missed more than
two consecutive FUs before the end of treatment (FU6) or did

195

not return within one month of their nal follow-up (FU7) were
excluded from the analysis. If a single absence was foreseen in
advance, the subjects were instructed on the home program
changes at the previous appointment, and therefore only the
data was lost but no delays of treatment progression program
occurred. All subjects from the LTTP group returned for the nal
evaluation but one subject in the QC group was lost to follow
up after FU3. One subject sustained 3 ipsilateral mallet injuries.
For statistical analysis purposes, one nger was randomly
selected and the remaining 2 ngers removed so that all
subjects contributed only once to the data set. Thus, 30 ngers

Assessed for eligibility (n= 68)

Enrollment

Excluded (n=10)

Randomization
(number of fingers=60)

Allocated to LTTP Orthosis (n=30)

Assessed (n=30) Missed appt. (n=0)

Allocation

Allocated to QC Orthosis (n=30)

Baseline

Assessed (n=30) Missed appt. (n=0)

Assessed (n=30 ) Missed appt. (n=0)

FU1 (3-4 wks) Mid-way immobilization

Assessed (n=30 ) Missed appt. (n=0)

FU2 (6-8 wks) Begin intermittent exercises

FU3 (7-9 wks) added active extension

Assessed (n=29) Missed appt. (n=1)

Assessed (n=30) Missed appt. (n=0)

FU4 (8-10 wks) orthotic wear to night only

Assessed (n=26) Missed appt. (n=4)

FU5 (10-12 wks) D/C orthosis at night

Assessed (n=27) Missed appt. (n=3)

FU6 (12-14 wks) D/C exercises

Assessed (n=30) Missed appt. (n=0)

FU7 (24-28 wks) Final follow up

30 were included in the intent-to-treat analysis

Assessed (n=30)

Missed appt. (n=0)

Assessed (n=30) Missed appt. (n=0)

Assessed (n=29) Missed appt.(n=1)

Assessed (n=24) Missed appt.(n=5)

Lost to FU (n=1)

Assessed (n=24) Missed appt. (n=5)

Assessed (n=23) Missed appt. (n=6)

Assessed (n=28) Missed appt. (n=1)

2 out of 3 fingers from same patient removed

27 were included in the intent-to-treat analysis

Analysis
Fig. 3. Flow chart.

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S. Tocco et al. / Journal of Hand Therapy 26 (2013) 191e201

in LTTP group and 27 in QC group were analyzed at study

completion.

an 81% success rate for the QC group. However, the difference was
not statistically signicant (c2 3.13, df 1, p 0.08).

Baseline data and follow up data

Orthotic removal

Demographics of patients by group for the objective and

subjective data are presented in Table 3. Results show that all
variables were similar at baseline. Table 4 presents median and
range, as well as results from the WRS tests, of the time elapsed
between evaluation sessions. Results show that groups were
similar at all time points.

Table 5 compares nal DIPj active extension decit and recovery

from baseline for patients who did not adhere to the full-time
wearing regime. Only half of the LTTP users removed their orthosis
daily as instructed and 1 patient never removed his orthosis
throughout the immobilization period. Nearly 25% of QC users
removed their orthosis during the immobilization phase and some
reported cast removal occurred more than once a week during the
rst half of the immobilization period. Two subjects from the QC
group removed their orthosis regularly throughout the entire
immobilization period. Generally, the reason given for orthotic
removal was accidental (i.e., during hand washing or when replacing
their old adhesive tape strip), however, one subject reported
removing his cast to practice his favorite sport (judo) on a weekly
basis. When the data from FU2 and 3 was dichotomized (no removal
versus any removal) and compared using a Fishers exact test, there
were no signicant differences between groups at either time points.

DIPj extensor lag

Results from the repeated measures regression show that there is
an interaction effect between the orthotic design and time elapsed
from baseline. There was no signicant difference between the DIPj
extensor lag for either orthotic design until FU5 (approximately
12 weeks post-injury) where the QC group presented with an average
of 5 more active extension than the LTTP group (p 0.05) (Fig. 4).
Edema and age at injury also had a signicant effect on mean DIPj
extensor lag. Thus, the lower the edema the more active extension the
subject had at the DIPj, with a change of about 2 on average for every
Oval-8 Ring sizer unit (p 0.003). Similarly, the younger the subject,
the more active extension at the DIPj, with a change of 0.13 on
average per year of age (p 0.02). These effects were independent of
orthotic design. There was no effect of time from injury to orthotic
intervention initiation, type of injury (bone versus tendon), injury
mechanism, or the acuity of injury on DIPj extensor lag.
Success rate

Table 6 presents means and standard deviations of P2 edema

values for each group per follow up time. Results revealed that the
edema at all FU time points were similar except at FU2
(LTTP 1.1  0.8, QC 0.4  0.9; adjusted p 0.03) where subjects
wearing QC had signicantly less edema.
Orthotic discomfort

Using the modied version of the Gaberman and colleagues

scale, there was a 60% success rate for the LTTP group compared to
Table 3
Demographic and clinical data

Mean age (yrs  SD) at

admission
Sex n (%), F/M
Acuteness of injuryd, N (%)
Acute/chronic
Type of injury, N (%)
Bony/tendinous
Injury to the dominant
hand, N (%)
Finger injured, N (%)
Index
Middle
Ring
Small
Cause of injury, N (%)
Twisting
Fall
Impact from falling object
from above
Mean DIPj active extension
decit (  SD)
Mean edema (ring sizer
unit  SD)
Middle phalanx
Pain (median, range)
Splint aesthetics (median, range)

Edema

Group LTTP

Group QC

N 30

N 27

47.1  14.5

42.7  12.9

13 (43.3%)/17 (56.7%)
23 (76.7%)/7 (23.3%)

9 (33.3%)/18 (66.7%)
22 (81.5%)/5 (18.5%)

4 (13.3%)/26 (86.7%)

3 (11.1%)/24 (88.9%)

29 (96.7%)

26 (96.3%)

1
16
9
4

1
11
9
6

(3.3%)
(53.3%)
(30.0%)
(13.3%)

23 (76.7%)
6 (20.0%)
1 (3.3%)

(3.7%)
(40.7%)
(33.3%)
(22.2%)

22 (81.5%)
2 (7.4%)
3 (11.1%)

30  9.1

31.7  8.2

1.4  1.0

0.9a  0.8

1.1 cm (0e5.8)
2.2 cmb (0e9.5)

0.8 cma (0e7.4)

0.7 cmc (0e9.7)

Range (max  min).

a
N 26.
b
N 29.
c
N 25.
d
Acute injury: 21 days old; chronic injury: 22 days old.

Pain related to orthosis wear was evaluated using a 10 cm

visual analog scale. Reports of pain were similar between groups
at FU1. The median for the LTTP group (N 30) was 0.2 cm (range
0e6.4) and the median for the QC group (N 24) was 0.6 cm
(range 0e3.9). This difference was not statistically signicant
(WSR test p 0.14). At FU2 pain was reported to be signicantly
lower (WRS test p 0.03) in the LTTP group (median 0, range
0e2.2, N 29) than in the QC group (median 0.4, range 0e4.6,
N 25).
Orthotic aesthetics
Subjects evaluation of the esthetic quality of the orthoses at FU1
were marginally signicantly different (WSR test p 0.05). The
median for the LTTP group (N 28) was 3.5 cm (range 0e8.8) and
for the QC group (N 24) it was 0.9 cm (range 0e6.0). At FU2,
however, there was no statistically signicant difference (WSR test
p 0.13) (median for LTTP 2.2 cm, range 0e9.9, N 29, and
median for QC 0.7 cm, range 0e8.8, N 25).
Outcome satisfaction
Subjects overall satisfaction with their outcome was evaluated
at FU7 using the VAS anchored with completely dissatised and
completely satised. An analysis of covariance with outcome
satisfaction as the dependent variable, orthotic design as the main
factor and DIPj extension lag as covariate, showed that DIPj
extension lag had an effect on outcome satisfaction with an average
decrease in VAS of 0.12 for every 1-degree increase in DIPj extension lag (s.e. 0.03, t 3.73, p < 0.001). This effect was independent of the orthotic device. There was no signicant difference
in outcome satisfaction based on the orthotic design. Adjusted VAS

S. Tocco et al. / Journal of Hand Therapy 26 (2013) 191e201

197

Table 4
Elapsed days between follow-ups, duration of the immobilization
Variable

Time from injury [days (range)]

Time elapsed between baseline and FU1
Time elapsed between FU1 and FU2
Duration of the immobilization phase
Time elapsed between FU2 and FU3
Time elapsed between FU3 and FU4
Time elapsed between FU4 and FU5
Time elapsed between FU5 and FU6
Time elapsed between FU6 and FU7
Time elapsed between baseline and end of study
a

Group LTTP

Group QC

Median (range)

Median (range)

30
30
30
30
29
29
26
24
27
30

4
21
21
42
7
7
7
7
100
173.5

27
26
26
27
26
22
19
18
21
27

7
21
21
42
7
7
7
7
107
181

(1e110)
(15e33)
(19e35)
(36e63)
(5e9)
(5e12)
(5e9)
(4e10)
(75e119)
(165e210)

(0e53)
(15e31)
(15e29)
(36e57)
(4e10)
(4e10)
(6e9)
(5e10)
(82e131)
(157e202)

p-value

0.46
0.71
0.26
0.14
0.80
0.79
0.38
0.25
0.10
0.03

Holm adjusted p-value

1.00
1.00
1.00
1.00
1.00
1.00
1.00
1.00
0.89
0.33

Wilcoxon rank sum test.

means were 1.8 cm and 1.0 cm for LTTP and QC respectively

(p 0.23).
Active DIPj exion stiffness
Means and standard deviations of DIPj exion stiffness at follow
up times per group are presented in Table 7. Results show the
progressive recovery of DIPj exion after beginning the active
exion exercises at FU3. Results of the t-tests performed to
compare mean DIPj active exion decits between groups at each
follow up time show no statistical signicant differences for this
outcome throughout the study.
Strength
Grip and tip-to-tip pinch strength in this study were reported as
a percentage between the affected and unaffected hand and ngers
respectively. Table 8 shows means and SD for grip and pinch
strength per group. They were similar between groups at all FU
evaluations. Nearly full recovery of grip strength relative to the
unaffected extremity was achieved by the end of the study (FU7;
LTTP 98.2%, QC 96%) and the same trend was exhibited for
pinch strength, but to a lesser extent (FU7; LTTP 93.4%,
QC 90.8%).
Treatment complications
Assessment of skin maceration severity was performed at FU 2,
3 and 4. Table 9 shows the frequencies of maceration levels per
group at each follow up time. There were no cases of severe skin

complications (ulceration or necrosis) in this study. In both groups,

the majority of subjects had no maceration at any of the 3 follow
ups and the remainder of the subjects had traces of maceration.
Subjects that presented with moderate maceration in either group
admitted they did not adhere to the therapists instructions. LTTP
subjects did not remove their orthosis on a daily basis and those
from the QC group covered the entire orthosis, instead of the most
proximal portion only. There were no statistically signicant
differences between groups at any of the three follow up times (FE
test p 0.13, p 0.39 and p 1.0 at FU2, FU3 and FU4, respectively).
In this study, PIPj hyperextension of 10 and a DIPj extensor lag
of 10 were considered a swan-neck deformity. Seven subjects in
the LTTP group presented this deformity (23.3%) in comparison to 2
in the QC Group (7.4%). This difference, however, was not statistically signicant (FE test p 0.15).
Discussion
Relationship between orthosis type, age, removal frequency and
edema on DIPj extension
At the end of treatment, subjects treated with QC had a mean
DIPj extensor lag of a little less than 5 whereas subjects treated
with the LTTP orthosis had an average 9 extensor lag. This difference fell short of statistical signicance (p 0.05). Furthermore, at
all follow ups QC users demonstrated better DIPj extension than
LTTP subjects without however reaching statistical signicance.
This lack of signicant difference may be due to the study being
underpowered. From a clinical point of view, QC full-time immobilization reduced by almost 50% DIPj extensor lag in comparison to
custom-fabricated thermoplastic orthotic intervention in mallet
nger injuries. No other quantitative report on the conservative
treatment of mallet injuries using Quickcast nishing tape was
found in the literature. Subjects treated with the LTTP orthosis in
this study had similar results to those reported in recent studies

Table 5
Splint removals during immobilization period and nal DIPj extension outcomes

Fig. 4. DIPj extensor lag between groups throughout the study.

Group

Finger ID
number

FU1 removal
frequency
(per week)

FU2 removal
frequency
(per week)

FU7 DIPj
ext. decit

FU7 DIPj ext.

gain from
baseline

LTTP
QC
QC
QC
QC
QC
QC
QC

38
1
2
5
17
43
49
60

0
1
0
0
0
3
2
1

0
1
1
1
1
1
0
0

5
20
0
0
0
0
10
0

25
25
35
30
30
20
15
20

198

S. Tocco et al. / Journal of Hand Therapy 26 (2013) 191e201

Table 6
Oval-8 ring sizer mean difference between unaffected and affected nger in both
groups throughout the study
Edema

Middle
FU1
phalanx (P2) FU2
FU3
FU4
FU5
FU6
FU7
a

Evaluation Group LTTP

Group QC
period
N (mean  SD)
28
30
29
30
26
27
30

(0.8
(1.1
(1.0
(0.9
(1.2
(1.2
(0.8









1.0)
0.8)
1.0)
0.8)
1.0)
1.1)
0.7)

23
27
26
22
21
21
27

(0.7
(0.4
(0.9
(0.9
(0.9
(1.1
(0.6









1.0)
0.9)
1.0)
1.2)
1.0)
1.1)
0.8)

p-value Holm
adjusted
p-value

0.86
0.04
0.58
0.95
0.38
0.89
0.45

1.00
0.03
1.00
1.00
1.00
1.00
1.00

t-test.

with similar orthotic models and donning approach.18,28,35,39,40 If

compared to studies reported by Pratt,14 QC subjects reached
similar or better outcomes.
In the present study, age had a signicant effect on the primary
outcome in favor of younger subjects. A similar nding was reported by Pike and colleagues40 who found a moderate and inverse
correlation between age and DIPj extensor lag on radiographs,
suggesting that increasing age results in poorer extension on Xrays. An older study also found that success rate is poorer in older
subjects.26 The results in this study revealed that patients older
than 60 years of age failed or had poor results after orthosis wear
and those aged between 41 and 60 had a successful treatment in
60% of the cases. Warren and colleagues41 demonstrated that there
is poor blood supply in the vicinity of a healthy extensor terminal
tendon. Older patients suffering from circulatory problems, Type 2
diabetes or any other disease commonly found in older people in
addition to slower metabolism, i.e., production of collagen and
broblasts, may have reduced tendon healing capabilities. Thus,
older patients with co-morbidities may benet from a longer
immobilization period and a more gradual reduction in wear time
than younger, healthy patients, however this proposal needs to be
empirically tested. Other independent variables such as time of
treatment from injury onset, mallet type, injury mechanism,
acuteness of the injury had no effect on nal DIPj extension.
These ndings are similar to those already reported in the
literature.25,26,41
The prescribed wearing schedule also had a signicant effect on
the nal outcome favoring the full-time immobilization method
over the traditional self-removal approach. Since no comparative
study was found in the literature, an attempt was made in the
current study to determine the importance of accidental motion of
the DIPj during the immobilization period. Although correlations
could not be made between orthosis removal and nal ROM
outcomes, individual observation of subjects that accidentally
removed their QC during the immobilization phase did not result in
poorer DIPj extension at their nal follow up. In fact, only 1 subject
out of the 7 who did not adhere to the full-time wearing schedule
from the QC group failed according to the modied Gaberman and
colleagues scale,35 but this was the case of intentional removal by
Table 7
Active nger exion decits between groups after beginning exion exercises
Evaluation period

FU3
FU4
FU5
FU6
FU7
a

t-test.

Group LTTP

Group QC

Mean  SD

Mean  SD

29
30
26
27
30

36.4
26.5
11.9
10.0
4.2

26
22
23
21
27

36.5
24.8
12.0
11.7
6.3







19.4
18.3
12.2
10.5
11.4







16.0
14.3
10.7
11.3
12.3

Table 8
Grip and tip-to-tip strength ratio between groups after beginning exion exercises
Evaluation Pinch
period
Group LTTP

FU4
FU5
FU6
FU7

Mean  SD N

30
26
27
30

64.2
77.3
83.3
93.4






22.0
21.1
17.8
14.8

22
23
21
27

Group LTTP

Mean  SD N
69.4
78.6
77.1
89.4






36.8
55.0
27.5
18.0

30
26
27
30

Group QC

Mean  SD N
77.9
87.7
87.8
98.2






17.1
15.3
14.9
9.4

21
22
20
26

Mean  SD
77.0
84.6
90.0
96.0






18.4
17.0
16.0
12.6

the subject to practice judo on a weekly basis. All other subjects had
a successful outcome. Some reports also corroborate the hypothesis
that minimal joint movement may not hinder terminal tendon
repair. Hovgaard and Klareskov42 used an elastic double-nger
bandage which did not continuously immobilize the DIPj in
extension but prevented exion of the joint beyond 5 . Despite this
possible motion at the DIPj, 68% of subjects treated with this elastic
orthosis had full DIPj extension following treatment. Another
orthosis model which does not completely immobilize DIPj
movement is the moon sock.43 No data are presented in this report
but according to the author their nal outcomes were acceptable
when used as an adjunct to conventional orthotic positioning.
Results did not show an interaction between orthosis type and
edema but a signicant reduction of edema in the QC group was
observed at the end of the immobilization phase. Also, a statistical
signicant relationship between the amount of edema in the nger
and nal outcome was found, indicating that non-edematous
ngers at the end of the immobilization phase resulted in greater
nal DIPj extension. This result may be explained in part by the QC
material properties which provide compression when wrapped
around the nger. In addition, although it is not yet fully understood how casting materials favor edema reduction, Colditz44 has
listed edema reduction as one of the properties of plaster of Paris in
treating stiffness and chronic edema. From a physiological
perspective, excessive edema may hinder wound healing by
decreasing arterial, venous and lymphatic ow45 thereby
increasing the probably of an extensor lag in swollen mallet ngers.
Once more, patients successfully treated with compressive
orthoses such as the elastic double-nger bandage42 and moon
sock orthosis43 may have beneted from their anti-edematous
characteristic, similarly to that provided by QC nishing tape.
Success rate
The success rate was slightly greater in the QC group (81%) than
in the LTTP group (60%) but fell short of statistical signicance
possibly due to the small sample size. As was highlighted in the
Cochrane review,5 authors use their own success rating scale which
makes it difcult to compare results between studies. Pratt14 made
Table 9
Maceration levels severity between groups
Evaluation period

FU 2

p-value
FU 3

0.98
0.99
0.99
0.60
0.50

Grip
Group QC

FU 4

Maceration
severity
A
T
M
A
T
M
A
T
M

A absent; T trace; M moderate.

a
Fishers exact test

Group LTTP

Group QC

20
6
4
22
7
1
24
4
0

66.7
20.0
13.3
73.3
23.3
3.3
85.7
14.3
0.0

23
1
2
17
10
0
22
4
0

88.5
3.8
7.7
63.0
37.0
0.0
84.6
15.4
0.0

p-value

0.13

0.39

1.00

S. Tocco et al. / Journal of Hand Therapy 26 (2013) 191e201

an attempt in showing various study results that used the original

Abouna & Brown scale26 or personal outcome measures. In those
studies, success rates varied between 33% and 95%, but none of the
reviewed studies used either the modied-Abouna & Brown scale
or the Gaberman and colleagues scale.35 Thus the authors of the
Cochrane review recommend using a more detailed scale, with
clearly dened ROM and/or pain levels to facilitate comparison
between future mallet nger injury studies.
Hand function related to orthosis type
Finger pain related to orthosis discomfort was lower in the LTTP
group at the end of the immobilization period but the difference
was so small (0.4 cm) that it cannot be considered clinically
important. Nevertheless, these ndings differ from those reported
by Stern and Kastrup16 who stated that 6% of subjects complained
of pain due to their thermoplastic orthosis. A qualitative homemade pain scale was used in their study, making it difcult to
compare results with those of the present study.
Overall, subjects in both groups were satised with the
aesthetics of their orthosis at baseline. However, the QC group was
slightly more satised than those from the LTTP group when they
were questioned about the aesthetics at their rst follow up
appointment. Some subjects in the QC group did mention that
friends and family members were intrigued by their nger cast as
they had never encountered this type of cast. This may have
rendered the cast orthosis more attractive than the more common
orthosis. Indeed, this group difference was lost at the next follow up
evaluation.
No treatment approach resulted in greater subject satisfaction
with regard to their nal DIPj extension recovery. However, it is
interesting that those with poor DIPj extension at the end of
treatment were very dissatised with their treatment. This may
assist health professionals in deciding which steps to take if
conservative treatment fails.
Distal interphalangeal joint exion was limited in both groups
after the immobilization phase but there were no differences
between groups. This limitation was most likely due to stiffness and
could not be assessed properly through passive exion testing since
this maneuver was contraindicated at that stage of the healing
process. Active DIPj exion consistently improved throughout the
remainder of the study and approximately 5 decits remained in
comparison to the contralateral healthy nger at their nal 6
months follow up. Flexion recovery could be accelerated by introducing passive composite exion exercises after discontinuing the
orthosis, but at the risk of creating an extensor lag. The authors
recommend passive composite exion exercises only in severe
cases of stiffness 6 months after treatment is initiated. Cases of
severe stiffness in the DIPj may occur with bony mallet injuries due
to excessive callus formation and should be evaluated with radiographs. Another reason for DIPj exion limitation may be related to
oblique retinacular ligament shortening. In this case, passive
stretches are applied only to the DIPj while the PIPj is held in
extension. These types of complications did not occur in the present
trial even when immobilizing the DIPj for up to 8 weeks with a cast.
There were no differences between groups with respect to grip
and tip-to-tip strength. Grip and pinch strength gradually
improved after full nger exion was allowed. At the end of the
study, subjects from both groups had mean grip and pinch strength
only slightly below their contralateral side.

199

with fewer cases of mild to moderate maceration than the LTTP

group, which supports the claim that this synthetic casting material
has superior aeration characteristics which allows for a continuous
wearing schedule. The subjects in the QC group who presented
with traces or moderate maceration where mainly patients that
applied more than a single adhesive tape wrap around their cast or
used non-brous adhesive tape (i.e., synthetic tape) thus blocking
skin aeration underneath, thus instructions about tape type and
application procedures should be strongly reinforced. There were
no cases of ulceration or other skin complication in this study, even
for subjects using the LTTP orthosis. Kinninmonth and Holburn39
had a single case (4%) of skin irritation with a custom-fabricated
perforated lever-type orthosis which occurred in a nurse after
using Hibisol regularly. Other studies report no complications after
using custom-fabricated thermoplastic orthoses.17,28,37,46 Cases of
skin ulceration or severe maceration can be found in the literature
but these ndings occurred with prefabricated high-temperature
thermoplastic orthoses or custom-fabricated orthoses made of
other materials.16,25,47e52 Both orthotic materials used in this study
had minimal adverse events but as has been suggested in other
studies,25,44 it is important to regularly assess the skin during the
immobilization phase and instruct the patient to return for follow
up if any issues are identied. Quickcast nishing tape can be held
in place for longer periods of time than perforated thermoplastic
but still requires occasional monitoring by the therapist as dirt may
be trapped beneath the cast and irritate the skin.
The LTTP group had more occurrences of PIPj hyperextension
than the QC group at the end of this study. Lateral bands dorsal
migration is common with terminal tendon injuries.53 In a clinical
setting, when a swan-neck deformity is associated to a mallet
injury, it is recommended to apply a dorsal hood over the PIPj thus
keeping this joint slightly exed to approximately 20e30 . This
position reduces isometric tension at the terminal tendon rupture
site, favoring a better healing of the tendon. This was not done in
this study but the authors do recommend it in clinical practice.
Study limitations
Time constraints and limited economic resources prevented
enrolling a larger sample which would have given additional
statistical power to the study. Power calculations were not performed prior to initiating this study since data collection was time
limited to a one year maximum. Since 70 patients on average were
admitted to our hospital emergency room the 3 years prior to study
initiation this number was the anticipated maximal enrollment. As
expected, several subjects did not meet the inclusion criteria;
therefore the study included 60 ngers initially. Despite having
only one drop-out, 2 additional ngers were removed from the
analysis in the subject with triple injuries. However, this study may
have not been adequately powered to determine statistical significance between groups for a number of the variables that were
analyzed.
Some assessment tools used in this study are not yet standardized and validated. Also, inter-rater reliability analysis could
not be performed in this study, as practice data was not recorded
before and during the data collection period. This drawback was
somewhat offset by the method of reporting objective values as
a difference between the unaffected and affected side and assigning
the same evaluator for given subjects throughout the entire study.
Clinical relevance and future considerations

Complications
In this study, skin maceration was minimal. Although there were
no statistical differences between groups, the QC group did present

The ndings of this study demonstrate that full-time immobilization with QC of Type 1 mallet ngers was more effective than
the traditional approach of fabricating an LTTP orthosis and

200

S. Tocco et al. / Journal of Hand Therapy 26 (2013) 191e201

instructing the patient to remove it daily for skin care. Cast

immobilization resulted in greater edema reduction, better DIPj
extension gains and had no detrimental effects on nger exion or
hand and nger strength. The casting material used in this study
offers similar functional advantages to low temperature thermoplastic. Edema reduction and age rather than accidental orthosis
removal, seemed to have a more substantial impact on the
successful treatment of mallet nger injuries but further investigation into this relationship is warranted. Additionally, further
investigation of the immobilization duration and orthosis discontinuation process after a mallet nger injury is warranted to
improve success rates, particularly in older patients and when
edema is signicant.
Acknowledgments
The authors thank the subjects from Policlinico of Modena who
participated in this study for their valuable contributions. The
statistical support of Dr. Jos A. Correa is gratefully acknowledged.
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201

JHT Read for Credit

Quiz: #269

Record your answers on the Return Answer Form found on the

tear-out coupon at the back of this issue or to complete online
and use a credit card, go to JHTReadforCredit.com. There is
only one best answer for each question.
#1. In this study, once the immobilisation period was completed,
the orthosis was intermittently removed and a home-based
exercise program initiated. Which of the following correctly
describes the rst step after the immobilisation period
a. the orthosis was donned only at night and sting exercises
were begun
b. the orthosis was donned only during daytime and intrinsic
strengthening (interphalangeal extension) exercises were
begun
c. the orthosis was donned at night and between exercises and
intrinsic strengthening exercises alternated with sting
exercises were begun
d. the orthosis was donned at night and between exercises
and only intrinsic strengthening exercises were begun
#2. Subjects in this study were assigned to receive 2 different
orthotic treatments. Which orthoses were used
a. volar thermoplastic (TP) orthosis and Quickcast tape
orthosis
b. volar TP orthosis and Stack orthosis
c. lever-type TP orthosis and Quickcast tape orthosis
d. lever-type TP orthosis and Stack orthosis
#3. Many outcomes in this study showed differences between
groups in favor of the Quickcast group but fell short of statis-

tical signicance. Which one of these outcomes was better

for the Quickcast group but fell short of statistical signicance
a. success rate (modied-Gaberman scale)
b. grip strength
c. DIP exion stiffness
d. maceration rate
#4. The immobilisation period selected for all participants in this
study was identical. However, this differs from the recommendations suggested by the Indiana Hand Center. According to
their protocol, what variable determines the number of weeks
that someone with a mallet nger injury should wear an
orthosis
a. edema
b. acuity of injury
c. type of injury (bony vs. tendinous)
d. age of the patient
#5. Before this study, it was believed that minimal DIP motion
during self-orthotic removal was responsible for conservative
treatment failures. According to the results in this study, this
is not the case but the treatment success does appear to be
related to other factors. Which factors seem to negatively inuence DIP extensor recovery?
a. edema and baseline DIP extensor lag
b. edema and older aged participants
c. edema and old injuries
d. edema and bony injuries
When submitting to the HTCC for re-certication, please batch your
JHT RFC certicates in groups of 3 or more to get full credit.

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permission.