Factors Affecting the Pullout

Strength of Cancellous Bone

J. R. Chapman Screws
Screws placed into cancellous bone in orthopedic surgical applications, such as
R. M. Harrington fixation of fractures of the femoral neck or the lumbar spine, can be subjected to
high loads. Screw pullout is a possibility, especially if low density osteoporotic bone
is encountered. The overall goal of this study was to determine how screw thread
K. M. Lee geometry, tapping, and cannulation affect the holding power of screws in cancellous
bone and determine whether current designs achieve maximum purchase strength.
Twelve types of commercially available cannulated and noncannulated cancellous
P. A. Anderson bone screws were tested for pullout strength in rigid unicellular polyurethane foams
of apparent densities and shear strengths within the range reported for human cancel-
lous bone. The experimentally derived pullout strength was compared to a predicted
A. F. Tencer shear failure force of the internal threads formed in the polyurethane foam. Screws
embedded in porous materials pullout by shearing the internal threads in the porous
material. Experimental pullout force was highly correlated to the predicted shear
D. Kowalski failure force (slope = 1.05, R^ = 0.947) demonstrating that it is controlled by the
major diameter of the screw, the length of engagement of the thread, the shear
Harborview Biomechanics Laboratory of the strength of the material into which the screw is embedded, and a thread shape
Department of Orthopaedics, factor (TSF) which accounts for screw thread depth and pitch. The average TSF for
University of Washington, Seattle, cannulated screws was 17 percent lower than that of noncannulated cancellous
WA 98195 screws, and the pullout force was correspondingly less. Increasing the TSF, a result
of decreasing thread pitch or increasing thread depth, increases screw purchase
strength in porous materials. Tapping was found to reduce pullout force by an average
of 8 percent compared with nontapped holes (p = 0.0001). Tapping in porous
materials decreases screw pullout strength because the removal of material by the
tap enlarges hole volume by an average of 27 percent, in effect decreasing the depth
and shear area of the internal threads in the porous material.

Introduction
Many orthopaedic surgical procedures require the use of bone
screws. Screws are placed into cancellous bone for the fixation
of fractures in epiphyseal and metaphyseal areas such as the
femoral head and condyles, proximal and distal tibia, talus,
calcaneus, pelvis and spinal vertebrae. These screws may sus-
tain high loads, which could render them susceptible to failure
by pullout. Failures have been reported for cancellous screws
used to fix fractures of the femoral neck (Ragnarsson, and Karr-
holm, 1991) and pedicle screws used in spinal fixation (Ransom
et al., 1994). This study was undertaken to define parameters
which affect the pullout strength of screws designed for cancel-
lous bone applications with the objective of increasing screw
purchase strength. The terminology used in describing the ge-
ometry and dimensions of bone screws, and the thread designs
of some of the screws tested in this research study are shown
in Fig. 1. The terms holding power, pullout strength, purchase
strength, and extraction strength have been used interchange-
ably in the scientific literature to refer to the maximum tensile
force attained while pulling a screw out of bone along its longi-
tudinal axis.
In general, cancellous screws are designed to have greater
thread depth (producing a greater difference between major and
minor diameters) and decreased thread cross-sectional thickness
in comparison to cortical bone screws, to provide more holding
power in porous materials such as cancellous bone (Perren et
Contributed by the Bioengineering Division for publication in the JOURNAL
OF BiOMECHANiCAL ENGINEERING. Manuscript received by the Bioengineering
Division September 2, 1994; revised manuscript received August 10, 1995. Asso-
ciate Technical Editor; S. A. Goldstein.
al., 1992). Other factors which have been found experimentally
to increase the holding power of cancellous bone screws in-
clude: increasing the major diameter of the screw (DeCoster et
al, 1990; Finlay et al., 1989; Nunamaker and Perren, 1976),
increasing the length of engaged screw thread (Daum et al.,
1988; Hughes and Jordan, 1972), inserting the screw in cancel-
lous bone of greater apparent density and shear strength (Bent-
erud et al., 1992; Carlson et al., 1992; DeCoster et al., 1990;
Finlay et al, 1989; Hughes and Jordan, 1972; Swiontkowski et
al., 1987), and decreasing the thread pitch (Baker et al., 1988;
DeCoster et al., 1990; Evans et al., 1990).
Several questions related to the design of cancellous screws
have not been specifically addressed. According to the AOV
ASIF (Arbeitsgemeinschaft fur Osteosynthesefragen/Associa-
tion for the Study of Internal Fixation) technique manual
(Schatzker et al., 1990), screws placed into cancellous bone do
not require tapping of the thread. Although the role of tapping
on the pullout strength of cancellous bone screws has been
addressed (Hearn et al, 1993; Heam et al., 1992; Nunamaker
and Perren, 1976) the specific effect of tapping has not been
clearly established experimentally. A second question addressed
the effect of thread geometry, including thread depth and pitch,
on screw pullout strength. A third question related to the perfor-
mance of screws with cannulated shanks which allow the use
of a guide wire. Relative to noncannulated cancellous screws of
similar major diameter, cannulated screws have a larger minor
diameter to accomodate the central channel necessary to pass
the guide wire, which results in less thread depth. Although
increasing the minor diameter without changing the major diam-
eter should decrease pullout strength, Hearn et al. (1993) re-
ported a comparison between cannulated and noncannulated

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 cancellous screws which did not show any statistically signifi-
cant difference.
This research was performed to resolve discrepencies related
to screw design and hole preparation so that screw pullout
strength in cancellous bone can be enhanced. To accomplish
this we first established the use of porous foam as a substitute
for cancellous bone. Second, we set out to verify that a general
relationship between pullout strength and screw geometry and
material shear strength used for machine screw design held
also for bone screws placed into porous materials. Finally, the
specific effects of the following factors on pullout strength were
determined: (i) screw thread geometry, (ii) tapping, and (iii)
cannulation.
Methods
(a) Poly urethane Foam as a Model for Bone Screw Pull-
out Testing. The variations in apparent density, trabeculae
orientation, and mechanical properties of cancellous bone
within and between specimens are large, and so a very large
number of tests are required to isolate the effects of screw design
(Sell et al., 1988). Human bone is classified as cancellous if
it has an apparent density in the range of 0.09 to 1.26 g/cm',
or a porosity between 3(3 and 90 percent (Gibson and Ashby,
1988; Hayes, 1991). The compressive and tensile strengths of
cancellous bone have been shown to be related to (apparent
density)^, and thus vary by more than two orders of magnitude
over a typical range of densities (Carter and Hayes, 1976).
In order to study the effects of specific parameters related to
cancellous screws independently from variations in bone mate-
rial properties and geometry, rigid unicellular foam was selected
as a test material.
The pullout strengths of cancellous bone screws were tested
in uniform bars made of rigid unicellular polyurethane foam
(Last-A-Foam FR-3700, General Plastics, Tacoma, WA
98409). This material is available in bulk quantities with appar-
ent densities, which range from 0.05 to 0.64 g/cm^, with a
variation of ±3 percent in density as stated by the manufacturer.
Consistency throughout the material of shear strength, a mea-
sure of apparent density was confirmed by testing specimens
cut from the ends of the bars. Polyurethane foam has been used
previously in bone screw design research (DeCosteret al., 1990;
Finlay et al., 1989; Hearn et al., 1993; Hearn et al., 1992; Hein
et al., 1987; Shaw, 1987). Cellular solids have been extensively
studied as engineering materials, and their properties have been
shown to correspond well to the mechanical properties and
behavior of cancellous bone (Gibson and Ashby, 1988).
Foam materials of three densities were selected to encompass
a range of apparent densities and shear strengths of human
cancellous bone. These were defined as: low (0.16 g/cm'*),
medium (0.24 g/cm^), and high (0.32 g/cm'). A shear strength
value for each material was determined by testing 5 samples of
each foam using the punch tool method described in the Ameri-
can Society for Testing and Materials Standard D732-90
(ASTM, 1990). This test method utilizes two blocks between
which a specimen 50 mm square by 12 mm thick is rigidly
clamped. A punch-type shear tool of 25.4 mm diameter then
shears a plug of material. Shear strength is calculated as the
maximum load divided by area of the sheared surface (shear
tool circumference X material thickness).
In order to compare the relationship between density and
pullout strength for foam and bone, pullout tests, to be described
below, were performed in 10 samples of 6 week old calf lumbar
and thoracic vertebrae, and 10 samples of human vertebrae. The
human specimens were taken from fresh donated cadavers. All
specimens were dissected free of adhering soft tissues and stored
wrapped in wet cloths and sealed in plastic bags at -20°C until
used. After insertion and pull testing using 6.5 mm cancellous
solid screws of 16 mm thread length (model 216.60, Synthes
Ltd, Paoli, PA), a 1.905 cm diameter sample of trabecular bone
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surrounding the screw hole was cored from the specimen. The
screw hole was overdrilled to 0.635 cm to standardize its inter-
nal dimension. Apparent densities of the specimens were found
by first extracting marrow, then degreasing in ethanol, vacuum
degassing, centrifuging to remove residual water, and weighing.
Specimen apparent density was found by dividing weight by
specimen volume calculated from dimensions measured with a
caliper (Carter and Hayes, 1976).
(b) Comparison of Pullout Strengths of Different
Screws. Ten screws of the twelve types listed in Table 1 were
inserted into foam bars of the three densities, spaced 50 mm
apart, a large enough separation so that pulling a screw had
no effect on adjacent screws. The instruments supplied by the
manufacturers were used for screw placement. Pullout tests
were performed on a screw-drive materials testing machine
(Model 1122, Instron Corp., Canton, MA) at a constant cross-
head speed of 2 mm/min. The apparatus used consisted of a
simple fixture attached to the materials tester crosshead which
grasped the screw head protruding through a hole in a plate.
The plate was attached to the base of the tester. The foam Ijlock
rested against the underside of the plate. The screw-to-crosshead
coupling fixture permitted application of a pure tensile force
without inducing bending. Pullout force was measured by a
load cell having a capacity of 5 kN (Model 2511-317, Instron
Corp., Canton, MA), and data was sampled at 10 Hz using a
personal computer with an analog-to-digital convertor (2801A,
Data Translation Inc., Marlboro, MA). The maximum force
was determined for each test and defined as the pullout force.
(c) Verification of the Relationship Between Pullout
Strength, Thread Geometry, and Material Shear Strength.
Either the external thread on the screw or the internal thread in
the bone or porous foam will fail during pullout loading de-
pending on the relative strengths of each. The thread strength
is dependent on the material shear strength and shear area of
the threads. In the present study of stainless steel or titanium
bone screws inserted into polyurethane foam of shear strength
similar to that of human cancellous bone, stripping of the inter-
nal (foam) thread always occurred. The predicted shear failure
force necessary to strip the internal threads formed in the poly-
urethane foam was calculated from the following relationship
(FED-STD-H28, 1978; Oberg et al., 1987):
Fs = S*As = {S*L*7r*D,„ *TSF (1)
where:
Fs =
predicted shear failure force (N)
S =
material ultimate shear stress (MPa)
As =
thread shear area (mm^)
L =
length of thread engagement in material (mm)
£*roajor =
major diameter (mm)
TSF =
Thread Shape Factor (dimensionless) = (0.5 -I-
0.57735 d/p)
d = thread depth (mm) = (D„ajor - •Dn,i„or)/2
i'minor = mlnor (root) diameter (mm)
p = thread pitch (mm)
The product of ultimate shear stress, length and circumfer-
ence represents the force required to pull out an ideal cylindrical
plug. The thread shape factor (TSF) decreases the predicted
shear failure force depending upon the ratio of thread depth to
pitch. For the screws tested, the measured TSF varied from 0.70
to 0.87 (see Table 1). The screw pullout force was measured
experimentally. Using the geometry of the screw and the shear
strength of the foam, the shear failure force was also calculated
from Eq. (1). Pullout and shear failure forces were compared
to verify the relationship between thread geometry, material
shear strength, and screw pullout strength.
Transactions of the ASME
 Table 1 Cancellous bone screw types tested. Thread type C = cannulated, NC = noncannulated. All dimensions in mm.
Thread shape factor (TSF) = 0.5 + 0.57735 d/p. Manufacturer code (Mfr) A: Ace Medical Co., Los Angeles, CA 90061;
R: Richards Medical Co., Memphis, TN 38116; S: Synthes (U.S.A.), Paoli, PA 19301; Z: Zimmer, Warsaw, IN 46580.
Item Thread Screw Major Minor Thread Thread Pitch
Mfr number type length dia dia length depth (P) TSF

S 205.40 C 40 3.5 2.5 13 0.50 1.25 0.73

R 121840 C 40 4.0 2.75 14 0.63 1.75 0.71
S 207.40 NC 40 4.0 1.9 14 1.05 1.75 0.85
A 14225-40 C 40 5.0 3.75 20 0.63 1.8 0.70
S 216.60 NC 60 6.5 3.0 16 1.75 2.75 0.87
S 208.60 C 60 7.0 4.5 16 1.25 2.75 0.76
zA 1146-60 c 65 7.0 5.0 16 1.00 2.75 0.71
14088-60 c 65 6.5 5.25 20 0.63 1.85 0.70
R 121632 cNC 60 6.5 4.7 20 0.90 2.12 0.75
S 217.60 60 6.5 3.0 32 1.75 2.75 0.87
s 209.60 c 60 7.0 4.5 32 1.25 2.75 0.76
z 1146-60-32 c 65 7.0 5.0 32 1.00 2.75 0.71

(d) Cannulated Versus Noncannulated Screws. Since
cannulation or creation of a bore down the center of a screw to
allow its placement over a guidewire may change screw thread
geometry, we compared cannulated and noncannulated screws
in a subsection of this study. As shown in Table 1 the screws
tested were a 4.0 mm diameter noncannulated cancellous bone
screw (model 207.40, Synthes Ltd, Paoli, PA) with a TSF of
0.85 and a 4.0 mm cannulated bone screw (model 121840,
Richards Medical Co, Memphis, TN) with a TSF of 0.71. Screw
pullout testing was performed as described above.
(e) Effect of Tapping on Screw Pullout Force. Large
fragment cancellous bone screws (6.5 mm major diameter, 3.0
mm minor diameter, 1.75 mm thread depth, 2.75 mm pitch,
TSF 0.87, Synthes Ltd, Paoli, PA) were used to evaluate the
effects of hole preparation by tapping prior to screw insertion
versus self tapping during insertion. Tapped holes were created
in the foam bars of different densities using the pilot drill and
tap supplied by the manufacturer. Ten screws each of 16 and
32 mm thread length were inserted and pullout tests were per-
formed. The screws were then inserted into new pilot holes
which were not tapped, and pullout tests repeated.
(f) Interaction of Screw Thread Geometry and Tap-
ping. In order to determine if the effects of tapping were
independent or interacted with other design elements such as
thread depth and pitch, two types of machine screws with simi-
lar outside diameters to the previously tested screws, but with
much finer threads were tested (Fig. 1). The machine screw
=itch M M ,d = thread depth
= (Major dia - Minor dia)/ 2
i_ M i.i_i
- I — ^ '—r
'—Minor dia
-Lengt h- I— Major dia
6.5 mm dia cancellous thread
7.0 mm dia cannulated 1/4-20 UNBC 1/4-28 UI\H=
4.0 mm dia cancellous 3.5 mm dia cannulated
Fig. 1 Screw thread terminology and illustration of some of the thread
types tested. (1/4-20 UNRC and 1/4-28 UNRF are standard machine
screw threads, ali others are commercially available cancellous bone
screw threads). In the text, p = pitch, minor diameter = Dminor> major
diameter = D„^„
thread types tested are designated as 1/4-20 UNRC (coarse
thread, 0.25 in. major diameter, 20 threads per in., American
Standard for Unified Screw Threads, Revised Standard ANSI
Bl.1-1974, 6.35 mm major diameter, 4.79 mm minor diameter,
0.78 mm thread depth, 1.27 mm pitch, TSF 0.86) and 1/4-28
UNRF (fine thread, 0.25 in. major diameter, 28 threads per in.,
6.35 mm x 5.24 mm X 0.56 mm X 0.91 mm, TSF 0.86) (Holo-
Krome Co., West Hartford, CN). A lathe was used to remove
some of the machine screw threads leaving a 16 mm thread
length. The threads were inserted to a depth of 25 mm in the
high density polyurethane foam, with and without tapping, and
pullout tests were performed. This left the threads 9 mm below
the surface to ensure that the screws developed their maximum
pullout strengths.
(g) Effect of Tapping on Screw Hole Volume. The ef-
fect of tapping was determined by making a cast of the volume
into which the screw was placed using a high density, low
melting point alloy (CerroBend, Cerro Corp., Bellefonte, PA)
and comparing tapped and untapped hole volumes. Ten speci-
mens of each of the three types of foam were prepared by
drilling, tapping, inserting, and then removing (not pulling out)
a 6.5 mm diameter solid cancellous bone screw (model 217.60,
Synthes Ltd, Paoli, PA). Another 10 specimens of each type
of foam were prepared by drilling, inserting a screw without
tapping, and removing it. Each threaded hole was 50 mm long.
Debris was removed from the hole using an air jet and the foam
specimen was weighed. The alloy was heated to its melting
point of 70°C and poured into the screw holes. The polyurethane
foam i.s designed to shrink by less than I percent when heated
to 120°C for two hours, so placing casting material was not
expected to cause any appreciable volume change in the screw
hole. The foam specimen with casting material in place was
reweighed. The volume of the hole was then calculated from:
Volume = (W,- W„)/p (2)
where:
Wc = weight of foam specimen with casting material (gms)
W„ = weight of foam specimen after hole preparation but
without casting material (gms)
p = density of casting material (gms/mm^)
The calculated volume was confirmed by immersing the cast-
ings themselves in water in a graduated cylinder. In order to
normalize the data for slight variations in lengths of the castings,
the average cross-sectional area of each casting was calculated
by dividing the volume of the casting by its length.
(h) Statistical Analysis. Analysis of variance (ANO VA)
and regression analyses were performed on a personal computer
statistical software package (StatView 4.0.1, Abacus Concepts

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 4000
Shear Force/Displacement of Materials Used for Screw tests
3000 High Density (0.32 g/cm^S)
Shear failure force = 2920 N
Medium Density (0.24 a/<:m'^3)
Shear Failure Force = 2412 N
Calf Vertebra
2000
Shear Failure Force - 2114 N
Low Density (0.16 g/cm'^3)
1000 Shear failure Force = 1189 N
Displacement (mm)
Fig. 2 Typical shear force versus displacement curves for foam materi-
als of 3 different densities used in this study, and calf cancellous bone,
as tested by the method of ASTM D732-90 to determine shear strength
Inc., Berkeley, CA 94704). Differences were considered statis-
tically significant a t p < 0.05.
Results
(a) Polyurethane Foam as a Model for Bone Screw Pull-
out Testing. Typical foam material shear results are shown
in Fig. 2. The mean shear strengths were: low (0.16 g/cm^,
mean shear strength = 1 . 4 1 MPa, sd = 0.048 MPa), medium
(0.24 g/cm^ mean = 2.78 MPa, sd = 0.087 MPa) and high
(0.32 g/cm^ mean = 3.89 MPa, sd = 0.095 MPa). Figure 3
shows the relationship between material density and pullout
strength for the same screw type, size, and length, (6.5 mm
cancellous solid screw, 16 mm thread length, model 216.60,
Synthes Ltd, Paoli, PA) in three grades of foam as well as in
human and calf bone. The data also demonstrate how density
of cancellous bone and corresponding pullout strengths relate
to the densities of the foam materials selected. The human bone
used was in general from old, and likely osteoporotic specimens
so would be at the low end of the density range. The calf
bone represents young cancellous bone of considerably higher
density. The foam materials selected span the range of expected
bone densities. It is interesting to note the relatively large scatter
in pullout strengths of bone specimens (coeff of variation =
2000
Screw pullout strength vs material density
° Foam materials (n=35)
* Human cancellous bone (n=:f 0)
• Bovine cancellous bone (n=9) , 1106 N
^ \
00 0.1 0.2 0.3 0.4
Apparent Density (g/cm'^3)
Fig. 3 Screw pullout strength versus material density for human and
calf bone and foam materials of three different densities. (Screw used
was 6.5 mm diameter solid cancellous screw, 16 mm thread length,
model 216.60, Synthes Ltd, Paoli, PA.)
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0.412) in comparison to foam (low density, coeff of variation
= 0.055), which validates our hypothesis that foam, because
of its uniform density is a better model for testing bone screws.
(b) Comparison of Pullout Strengths of Different
Screws. Comparative force-displacement data generated dur-
ing pullout testing of a large fragment cancellous bone screw
(6.5 mm solid cancellous bone screw, 16 mm thread length,
model 216.60, Synthes Ltd, Paoli, PA) in the three foams of
different densities are shown in Fig. 4. The maximum pullout
force for this screw occured at a displacement of 1.25 mm in
low density foam. For this screw having a pitch of 2.75 mm,
this displacement corresponds to rotating the screw less than j
of a turn from the point at which it starts to become tensioned
to the point at which the internal threads fail. In high density
foam, maximum pullout force occurred at a displacement of
2.25 mm which corresponds to approximately | of a turn. There-
fore the range of rotation available during tightening of the
screw is between 180° and 270° before over-tightening and
stripping of the threads occur in these materials.
The mean pullout force for each cancellous screw in each of
the three types of foam is shown in Table 2. The pullout force-
displacement data were very consistent for any particular screw
and foam with most coefficients of variation being less than 6
percent. The greatest variation was 19 percent, which occurred
for the smallest screw tested in the lowest density foam. These
results demonstrate in general that pullout strength increases
with screw diameter and material density (or shear strength).
(c) Verification of the Relationship of Pullout Strength
to Thread Geometry and Material Shear Strength. The
measured pullout force for each screw tested was correlated to
its predicted shear failure force based on Eq. (1), as shown in
Fig. 5. The slope of this relationship (m = 1.05) and high
correlation coefficient (R^ = 0.947) indicates that screw diame-
ter, length of insertion, thread geometry (thread shape factor)
as well as the shear strength of the material into which the
screw is placed can be used as predictors of screw pullout force.
(d) Cannulated Versus Noncannulated Screws. The
pullout force of 4.0 mm diameter cannulated screws was 20
percent below that of noncannulated screws of equivalent diam-
eter, length and thread pitch (Fig. 6). This was a statistically
significant reduction in strength (p < 0.01). The threads of
both screws have a 4.0 mm major diameter, 14 mm length, and
1.75 mm pitch. The noncannulated screw has a thread depth of
1.05 mm and a resulting TSF (thread shape factor) of 0.85.
The cannulated screw has a thread depth of 0.63 mm because
1500
High density foam
1250- "|.32 g/cm'^3
1000 vertebra
N
Medium density foam
iS; 750 0.24 g/cm*3
877 N
500
Low density foam
0.16 g/cm"3
250 361 N
Human vertebra
237 N
0.5
Displacement (mm)
Fig. 4 Typical pullout force vs displacement curves for large fragment
(6.5 mm diameter x 16 mm thread length, model 216.60, Synthes Ltd,
Paoli, PA) standard cancellous screws tested in foam materials of 3
different densities along with human and calf bone specimens
Transactions of the ASME
 Table 2 Mean values and standard deviations of pullout strengths for screws in foams of three different densities. Thread
type C = cannulated, NC = noncannulated. All dimensions in mm. Manufacturer code (Mfr) A: Ace Medical Co., Los
Angeles, CA 90061; R: Richards Medical Co., Memphis, TN 38116; S: Synthes (U.S.A.), Paoli, PA 19301; Z: Zimmer,
Warsaw, IN 46580.
Diameter (mm) Thread High density Medium density Low density
Mfr X length (mm) type pullout strength pullout strength pullout strength
S 3.5 X 13 C 370 ± 24 N 261 ± 18 N 61 ± 12N
R 4.0 X 14 c 518 ± 56 N 336 ± 27 N 153 ± 18 N
S 4.0 X 14 NC 631 ± 13 N 428 ± 9N 194 ± 25 N
A 5.0 X 20 cNC 843 ± 15 N 672 ± 35 N 264 ± 11 N
S 6.5 X 16 1129 ± 37 N 857 ± 9N 380 ± 13 N
S 7.0 X 16 c 938 ± 52 N 598 ± 14 N 298 ± 5N
zA 7.0 X 16 c 1153 ± 89 N 675 ± 47 N 273 ± 22 N
6.5 X 20 c 1139 ± 154 N 955 ± 33 N 326 ± 13 N
R 6.5 X 20 cNC 1343 ± 40 N 1027 ± 24 N 342 ± 13 N
S 6.5 X 32 2001 ± 51 N 1548 ± 14 N 716 ± 18N
S 7.0 X 32 C 2042 ± 46 N 1375 ± 16N 545 ± 17 N
z 7.0 X 32 C 2355 ± 127 N 1502 ± 64 N 467 ± 77 N

of the larger root diameter required for the central channel,
resulting in a TSF of 0.71, a 16 percent reduction below that
of the standard screw. This decrease in TSF accounts for most
of the decreased pullout force of the cannulated screws.
(e) Effect of Tapping on Screw Pullout Force. The re-
duction in pullout force due to tapping in foam materials was
statistically significant (p < 0.001) for all three densities (Fig.
7). The average reduction in pullout force due to tapping for
all three densities of foam was 73 ± 41 A^, a percentage reduc-
tion of 8 ± 4 percent.
(f) Interaction of Screw Thread Geometry and Tap-
ping. Compared with not tapping the pilot holes, tapping
caused a statistically significant reduction in pullout force (p
< 0.001) for both cancellous bone screws, as shown above,
and machine thread screws, all of similar major diameter (Fig.
8). The decrease in pullout strength due to tapping was greatest
for screws with the finest threads (smallest thread pitch). The
mean decrease in pullout strength was 234 N for the screws
with the fine 1/4-28 UNRF threads (21.5 percent), compared
to 84 N for the 1 /4-20 UNRC threads (8 percent) and 79 A^ for
the 6.5 mm diameter cancellous screw (6.9 percent).
(g) Effect of Tapping on Screw Hole Volume. The av-
erage cross-sectional area of the holes prepared for 6.5 mm
diameter bone screws with tapped threads was 15.4 ± 0.2 mm^
versus 12.2 ± 0.2 mm^ for non-tapped threads, an increase of
27 percent (Fig. 9). There was a statistically significant (p <
0.001), increase in hole area for the tapped threads in all three
foam densities. For comparison, the cross-sectional area through
the minor diameter of the threads on the 6.5 mm diameter
cancellous bone screw is 7.1 mm^, and the area through the
major diameter is 33.2 mm^.
Discussion
This study was performed to determine the relationship be-
tween some properties of bone screws and their resulting pullout
strengths. We first demonstrated that porous foams are an appro-
priate choice as a material for determining screw pullout which
eliminates the inter- and intra-specimen variability found in
bone. Second, a relationship used in the design of machine
threads, between screw pullout force and screw thread geometry
and shear strength of the material into which the screw was
placed, was verified by comparison to experimental pullout
force measurements. We found that the geometry of the screw
thread, specifically the ratio of thread depth to pitch, expressed
as the Thread Shape Factor (TSF) affects screw pullout force.
This implies that screw purchase can be enhanced for most
commercially available screws by increasing the TSF which

1000

3000

y = 1.05X - 44.81

R'^2 = 0.947, n = 360

3000 Experimental Predicted

Predicted Screw Failure Force (N)
Fig. 5 Relationship between experimentally measure^uliout force and
predicted screw failure force of the Internal threads formed in the poly-
urethane foam specimens (calculated from equation 1), since failure is
due to stripping of foam thread
Fig. 6 Comparison of experimentally derived pullout force and predicted
screw failure force for cannulated 4.0 mm diameter screws (model
121840, Richards i\1edicai Co, Memphis, TN) and noncannulated 4.0 mm
diameter screws (model 207.40, Synthes Ltd, Paoli, PA) of equivalent
thread lengths and thread pitches, In high density foam. Results for low
and medium density foam were similar (error bar = sd, n = 5).

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 1500
Effect of Tapping on Pullout Strength
in Different Density Foams
•
0
Tapped
Non-tapped
£. 1000 p<0.OS
500 p<0.05
Low lUled High
Polyurethane Foam Density
Fig. 7 Effect of tapping on pullout force for 6.5 m m diameter cancellous
b o n e s c r e w s of 16 m m thread length (model 217.60, Synthes Ltd, Paoli,
PA) in three different densities of f o a m . Results for screws of 3 2 m m
thread length w e r e similar (error bar = sd, *p < 0 . 0 5 ) .
results from a decrease in pitch (using a finer thread) or an
increase in thread depth. In porous foam, (and presumably can-
cellous bone) tapping removes considerable material from the
screw hole, enlarging it and reducing pullout strength. Cannu-
lated screws, with altered thread depth to pitch ratios compared
to solid screws to accomodate a central bore, have lower Thread
Shape Factors and pullout strengths.
Clearly, this study does not address biologic effects such as
apposition of bone around the screw threads which is known
to enhance pullout strength (Schatzker et al., 1975) with time.
This study should therefore be considered as representing a
worst case condition. Pullout was chosen as the direction of
testing for the following reason. A screw is a machine that is
designed to convert torque to compressive force between the
two objects that it engages. Therefore, pullout or pushout will
be the primary directions of force that a screw is designed to
resist. Screws may fail in shear when torque is applied, typically
during insertion, or by bending during loading transverse to
their long axis, but the strength of the screws in these modes
is related to the material of the screw and its diameter (and
cross sectional as well as polar moments of inertia) and has
little to do with the thread design, a primary focus of our study.
2000
Effect of Thread Pitch and Thread Shape Factor (TSF)
on Pullout Strength for Tapped and Nontapped Holes,
High Density Foam
• Tapped
1500 0 Non-Tapped
p < 0.05 p < 0.05
1000
500
Fig. 8 Effect of tapping on pullout force for 3 screws of similar major
diameter, length and TSF, but different combinations of thread depth
and pitch. Tests were performed in high density foam (error bar = sd).
396 / Vol. 118, AUGUST 1996
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i
I
I
Low iUedlum High
Foam Density
Fig. 9 A comparison of the average cross-sectional areas of prepared
screw holes after insertion and removal of screws, with and without
tapping, in porous foams of three different densities. Screw used was
6.5 mm diameter solid cancellous screw, 16 mm thread length (model
217.60, Synthes Ltd, Paoli, PA).
The thread shape factor (TSF), for a given screw diameter,
thread engagement length, and material shear strength, controls
the pullout strength of screws in porous materials. The TSF can
be increased by increasing thread depth and/or decreasing pitch.
Practically, other considerations such as excessively decreasing
the strength of the threads whose profile would become deeper
and thinner with increased TSF, limit the changes that can be
made to these parameters. One way to optimize the TSF would
be to design the external threads of the screw to equal the
strength of the internal threads in bone.
Defining an optimum value for the TSF clearly requires con-
siderable additional study. For the sake of discussion we com-
pared the differences in geometry of currently used screws and
those designed with a TSF of 1.00, by solving for the relation-
ship between pitch and thread depth. From Eq. (1) we obtain:
(0.5 + 0.57735 d/p) = 1, which yields,
p = 1.1547 c; (3)
Table 3 compares the thread pitches and the resulting shear
areas (i.e., L*7r*D„„jo,.*TSF) calculated using a TSF of 1.00,
with current cancellous thread designs.
The average thread shape factor (TSF) for the three noncan-
nulated cancellous bone screws was 0.86 ± 0.01, and for the
nine cannulated cancellous screws was 0.73 ± 0.03. This is due
to the cannulated screws being designed with a smaller thread
depth because of the presence of a central channel without a
proportional change in thread pitch. The pitch of the threads of
the cannulated screws tested seems to have been chosen to
match the pitch of noncannulated cancellous bone screw threads
of similar major diameter. For the screws tested, the shear fail-
ure force of cannulated cancellous bone screws was 15 percent
less than that of noncannulated cancellous bone screws of simi-
lar major diameter and length.
A guideline for the design of cannulated screws with greater
pullout strength can be suggested from this study. The maxi-
mum thread depth for a particular screw design may be limited
by the need for a central channel as in a cannulated screw, or
by the shear strength of the screw material (for example using
titanium versus stainless steel). If the minor diameter is too
small, the screw may fail during insertion or removal by shear-
ing under insertion torque. Once the thread major and minor
diameters are chosen based on screw strength considerations,
the pitch may be determined from Eq. (2) for a specified value
of the thread shape factor (TSF). The cannulated screws that
Transactions of the ASME
 Table 3 Thread depth and pitch as currently designed and pitch as predicted by Eq (2) for TSF = 1.0 to increase the
predicted shear failure force of the internal threads formed in porous material. Thread shear areas as currently designed
and for threads designed with TSF = 1.0. Thread type C = cannulated, NC = noncannulated. All dimensions in mm.
Manufacturer code (Mfr) A: Ace Medical Co., Los Angeles, CA 90061; R: Richards Medical Co., Memphis, TN 38116;
S: Synthes (U.S.A.), Paoli, PA 19301; Z: Zimmer, Warsaw, IN 46580.
Diameter (mm) Thread Thread depth Pitch Pitch (mm) Shear area Shear area (mm^)
Mfr X length (mm) type (mm) (mm) TSF = 1.0 (mm^) TSF = 1.0
S 3.5 X 13 C 0.50 1.25 0.58 104 143
R 4.0 X 14 C 0.63 1.75 0.73 124 176
S 4.0 X 14 NC 1.05 1.75 1.21 149 176
A 5.0 X 20 C 0.63 1.80 0.73 220 314
S 6.5 X 16 NC 1.75 2.75 2.02 283 327
S 7.0 X 16 C 1.25 2.75 1.44 268 352
zA 7.0 X 16 C 1.00 2.75 1.15 250 352
6.5 X 20 c 0.63 1.85 0.73 284 408
R 6.5 X 20 c 0.90 2.12 1.04 304 408
S 6,5 X 32 NC 1.75 2.75 2.02 567 653
s 7.0 X 32 cC 1.25 2.75 1.44 537 704
z 7.0 X 32 1.00 2.75 1.15 500 704

we tested have shallower thread depths because of their central
channels, but the thread pitch was not adjusted proportionally
to maintain the same TSF as the noncannulated screws. The
result is that the average TSF for the cannulated screw threads
is 0.73 compared with a mean of 0.87 for the noncannulated
screws (Table 1). All of the cannulated screws tested in this
study would benefit from a finer pitch which would increase
the TSF and the predicted shear failure force of the threads
formed in the porous material.
Our findings concerning thread geometry are consistent with
those of previous studies which found that finer threads had
higher pullout force (Baker et al., 1988, DeCoster et al, 1990;
Evans et al., 1990; Krag et al., 1986). Krag et al. reported on
custom screws with threads having a major diameter of 6 mm,
a minor diameter of 3.8 mm, and a thread pitch of 2 or 3 mm.
Equation (1) predicts that the screw with a 3 mm pitch would
have a 13 percent lower shear failure force than the screw with
a 22 mm pitch. Their data showed a decrease in mean pullout
strength from 1978 N to 1435 N (27 percent). DeCoster et al.
tested screws with a constant major diameter of 6 mm, a minor
diameter of 5 mm, and a pitch of 1.0 mm or 2.5 mm. Equation
(1) predicts that the thread with a 2.5 mm pitch has a 22 percent
lower shear failure force than the thread with a 1.0 mm pitch.
The data showed a decrease from 1360 A' to 1102 iV (19 per-
cent).
The AO/ASIF technique manual (Schatzker et al., 1990)
recommends not tapping in cancellous bone because it is
thought that inserting a screw without tapping compresses the
trabeculae and gives better holding power. The process of tap-
ping threads requires that the tap be inserted to cut the threads,
then removed and the screw placed into the prepared hole. Some
of the material cut by the tap is removed in the process rather
than being compressed into the threads. This is confirmed by
our measurement of a 27 percent increase in average thread
cross-sectional area for tapped versus non-tapped screw holes
in porous materials. When cutting threads in cortical bone or
other solid materials the material must be removed, therefore
tapping is beneficial; however, in porous materials and cancel-
lous bone, with self tapping, it can be compressed into the void
spaces. If it were possible to accurately measure the internal
diameter of the thread in foam due to tapping as opposed to
the minimum diameter of the screw thread the reduction in
pullout strength would probably be explained by Eq. (1).
Tapping exposes the material forming the internal threads to
many loading cycles as the tap and screw are inserted. The finer
the threads (smaller the pitch), the greater the number of turns
required to advance the screw into the hole. For example, the
6.5 mm diameter cancellous screw (2.75 mm pitch) requires 9
turns to advance 25 mm, the 1/4-20 UNRC screw (1.27 mm
pitch) requires 20 turns, and the 1/4-28 UNRF screw (0.91
mm pitch) requires 28 turns. The process of advancing and
removing the tap and inserting the screw requires 27 turns for
the cancellous screw and 84 for the fine thread machine screw.
This process breaks down the threads to some extent and may
be another factor which explains the three times greater reduc-
tion in pullout force found for fine threads compared with coarse
threads.
The choice of unicellular polyethylene foam as a test material
requires some comment. Two factors should be considered in
justifying the use of porous foam instead of bone. First, shear
strengths of the materials must be similar since screw purchase
strength has been demonstrated to be directly related to material
shear strength. Bovine trabecular bone has been shown to be a
good substitute for young human trabecular bone (Swartz et
al., 1991). Stone et al. (1983) tested bovine trabecular bone in
pure shear and found the following relationship between shear
strength, S (MPa) and apparent density, p (g/cm^): S = 21.6
p " ' ^ The physical property data sheet for the polyurethane
foam we used provides a similar relationship between shear
strength and apparent density: S = 23.9 p'^"*. Therefore choos-
ing foam materials of densities encompassing the range of tra-
becular bone should provide materials of similar shear strengths.
The data of Fig. 3 show that the foam materials we selected do
fall within the range of expected densities of cancellous bone
and importantly, demonstrate much less scatter in the data. Us-
ing foam should allow testing of screw design variables with
considerable fewer samples than equivalent tests in cancellous
bone. A second factor to consider is the internal architecture of
the foam, compared to bone. Both have high porosity and should
react similarly to tapping, that is compressing the material cut
by the threading procedure into the void space in the material.
The specific geometry of the trabeculae of cancellous bone is
highly irregular and likely varies greatly even along the length
of the screw so it is not possible to compare to the internal
architecture of porous foam.
In summary, the following have been shown in this study:
(a) Screws embedded in porous materials within the range
of densities and shear strengths of cancellous bone
shear the internal threads in the porous material during
pullout.
(b) Experimental bone screw pullout strength in porous
materials is highly correlated to that predicted for ma-
chine screws.
(c) The pullout strength of screws in porous materials is
governed by the following factors; the major diameter
of the screw, the length of engagement of the thread,
the shear strength of the material into which the screw

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 is embedded, and a thread shape factor which accounts
for thread depth and pitch.
(d) Increasing the thread shape factor by decreasing the
pitch (ie creating a finer thread), increases screw pur-
chase strength in a porous material.
(e) Cannulated screws that we tested had lower pullout
strengths than noncannulated screws of equivalent di-
ameter. These screws are apparently designed to have
similar thread geometries (thread major diameter and
pitch) as noncannulated screws; however, the necessary
decrease in thread depth because of the presence of the
central channel in the cannulated screw decreases its
thread shape factor, and pullout strength.
(/) Tapping in porous materials decreases screw pullout
strength because the removal of material by the tap
enlarges the hole considerably, in effect decreasing the
depth of the internal threads (in the porous material).
Acknowledgment
This work was supported by the University of Washington
Department of Orthopaedics. Implants used in this study were
donated by the manufacturers. The authors thank Laurel Rogers,
M. S., Johnson & Johnson Orthopaedics, Raynham, MA for
information on the shear failure force of threads; and Bob
Borchers, M. S., Prosthetics Research Study, Seattle, WA for
information on the shear strength of cancellous bone and cellular
solids.
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Transactions of the ASME