The Journal of Arthroplasty Vol. 12 No.

3 1997

Integral Porous Femoral Stem

5- to 8-Year Follow-up Study

David R. Mauerhan, MD,* Joseph Mesa, MD,~- Alexia M. Gregory, BS,*

and Jeffrey G. Mokris, MD*

Abstract: The outcome of total hip arthroplasty without cement was prospectively
followed in patients who received a titanium taper wedge femoral component with
a circumferential titanium plasma spray coating on the proximal surface (Integral
femoral stem, Biomet, Warsaw, IN). One hundred ninety femoral components were
implanted in 179 patients. Nine patients (9 hips) died prior to their 5-year exami-
nation, leaving 170 patients available for follow-up evaluation. Thirty-one of the
170 patients (33 hips) were lost at an intermediate follow-up period of 5 years
(mean, 5.8 years, range; 5-8 years), giving a follow-up rate of 82% for patients and
hips. The preoperative diagnoses included osteoarthritis (91 hips), avascular necro-
sis (38), post-traumatic arthritis (10), rheumatoid arthritis (4), congenital disloca-
tion of the hip (3), and fractures (2). The 78 men and 61 w o m e n had a m e a n age of
55 years (range, 18-81 years) and a mean weight of 81 kg (range, 50-136 kg). Pre-
operative Harris pain and function scores for the hip were 19.9 (range, 0-40) and
55.6 (range, 12-84), respectively. At the most recent follow-up visit, the mean pain
score increased to 41.2 (range, i 0 - 4 4 ) and the mean function score increased to
93.5 (range, 6-100). Thigh pain was present in 4% of the hips at the most recent
follow-up visit. Radiographically, 99% of the femoral components demonstrated
spot welds in the porous-coated zone. Two hips had demarcation of the femoral
component in the porous-coated zone consistent with fibrous fixation. None of the
femoral stems had been revised and there were no signs of aseptic loosening. Addi-
tionally, there were no cases of pain that could be directly attributed to the stem
and there was no evidence of distal femoral osteolysis. It is concluded that the Inte-
gral femoral stem provides excellent clinical and radiographic results at intermedi-
ate follow-up periods. K e y w o r d s - arthroplasty, Integral femoral stem, unce-
mented hip prosthesis, arthritis.

C e m e n t l e s s f i x a t i o n of t h e f e m o r a l c o m p o n e n t in cemented versus cementless fixation. Although

t o t a l h i p a r t h r o p l a s t y (THA) c o n t i n u e s to b e w i d e l y
u s e d as a n a l t e r n a t i v e to c e m e n t e d f e m o r a l fixa-
tion. C o n t r o v e r s y r e g a r d i n g t h e o p t i m u m m e t h o d
of f e m o r a l f i x a t i o n is d u e in p a r t to t h e d i s p a r i t y in
l e n g t h of f o l l o w - u p p e r i o d in s t u d i e s e m p l o y i n g
Prom the *Miller Orthopaedic Clinic, Charlotte, North Carolina, and
~The Rothman Institute, Philadelphia, Pennsylvania.
Reprint requests: Gary M. Kiebzak, PhD, Director of Research
Services, Miller Orthopaedic Clinic, 1001 Blythe Boulevard,
Suite 200, Charlotte, NC 28203.
several studies have shown excellent long-term
results with a cemented Charnley femoral compo-
n e n t at 15 to 20 y e a r s [1,21, o t h e r c e m e n t e d
f e m o r a l d e s i g n s h a v e h i g h e r r a t e s of a s e p t i c loos-
e n i n g at s h o r t e r f o l l o w - u p i n t e r v a l s [ 3 - 5 ] .
Clinical trials of b i o l o g i c a l l y f i x e d c e m e n t l e s s
c o m p o n e n t s of m u c h s h o r t e r f o l l o w - u p p e r i o d s
s h o w v a r i a b l e a n d m i x e d results. C a l l a g h a n et al.
reported 2-year results with the porous-coated
c o b a l t - c h r o m e f e m o r a l i m p l a n t [6]. Clinically, t h e r e
w a s a 1 6 % i n c i d e n c e of t h i g h p a i n a n d 2 8 % of
 Integral Porous Femoral Stem • Mauerhan et al. 251

patients had moderate or severe limp; however,

the average Harris clinical hip rating was 92.
Heekin et al., in a 5- to 7-year review of the same
prosthesis, reported Harris hip scores of 92 with a
15% incidence of continual thigh pain [7]. Radio-
graphically, fibrous fixation was present in 1%,
unstable fixation was present in 5%, and 5% of
the femoral c o m p o n e n t s had subsided. M a l o n e y
and Harris, in a matched-paired series of hybrid
THA, reported a 20% incidence of radiographic
loosening, 24% incidence of pain, and 16% inci-
dence of femoral revision in the u n c e m e n t e d
femur at 2 to 4 years [8]. Engh et al. have s h o w n
good clinical and radiographic results with the
AML c o m p o n e n t (DePuy, Warsaw, IN) at 10 to 12
years [9]. They reported 11-year survivorship of
91.8% in the original 166 single-sized AML stems.
They also noted osteolytic reactions in 25 (34%)
cases, which were confined to the calcar and
greater trochanteric area with no distal lysis.
Fig. 1. Integral femoral c o m p o n e n t profile; anteropos-
The purpose of this study was to present our terior and lateral views.
intermediate results from a series of patients w h o
were followed for a m i n i m u m of 5 years after
undergoing a THA with a titanium femoral compo- 0.5 m m to the real c o m p o n e n t to insure m a x i m u m
n e n t using cementless fixation.
fit and fill of the femoral canal. All surgeries were
performed by two surgeons (D.R.M. and J.G.M.).
The postoperative regimen included partial weight
Materials and Methods
bearing for 6 weeks, followed by advancement to
full weight bearing as tolerated by the patient.
B e t w e e n July 1986 and December 1989, 190 pri-
Of the 179 original patients, 9 (5%) died prior to
m a r y cementless THAs were performed in 179
their 5-year examination, and 31 (17%) patients
patients using the Integral femoral stem (Biomet,
(33 hips, 17%) were lost to follow-up evaluation,
Inc., Warsaw, IN), which was a tapered, collared,
leaving 148 hips in 139 patients with a m i n i m u m
titanium c o m p o n e n t with a circumferential tita-
5-year follow-up period (mean, 5.8 years; range,
n i u m plasma spray coating on the proximal 30 to
5-8 years). Multiple attempts were made to con-
40% of the stem (Fig. 1). The acetabular compo-
tact all patients lost to follow-up evaluation via
nents consisted of a threaded, titanium plasma-
certified mail and telephone calls at h o m e and at
sprayed hemispherical cup (32% of cases), a hemi-
work. Seven patients refused follow-up evaluation
spherical titanium plasma-sprayed cup with screws
because of inconvenience and stated that they
(34%), or a bipolar c o m p o n e n t (34%). Femoral
were doing well. Three patients had revision of
head sizes were 28 and 32 mm, the majority being
their failed threaded acetabular c o m p o n e n t s at
titanium alloy.
At follow-up evaluation there were 78 m e n
(56%) and 61 w o m e n (44%) with a m e a n age of Table 1. D e m o g r a p h i c s of Patients
55 (range, 18-81) and a m e a n weight of 81 kg With I n t e g r a l S t e m s
(range, 50-136 kg). The surgery was p e r f o r m e d on
66 (45%) right hips and 82 (55%) left hips. The Men/Women (n) 78/61
Age (y) 55 (range, 18-81)
preoperative diagnoses were primary osteoarthritis Weight (kg) 81 (range, 50-136)
in 91 hips, avascular necrosis in 38 hips, post-trau- Diagnosis
matic arthritis in 10 hips, r h e u m a t o i d arthritis in 4 Osteoarthritis 91
Avascular necrosis 38
hips, congenital dislocation of the hip in 3 hips, Post-traumatic arthritis 10
and fractures in 2 hips (Table 1). Rheumatoid arthritis 4
All surgeries were performed using a posterolat- Congenital dislocation of hip 3
Fracture 2
eral approach. Sequential conical reaming and Follow-up period (y) 5.8 (range, 5-8)
broaching were done with broaches undersized by
252 The Journal of Arthroplasty Vol. 12 No. 3 April 1997

other institutions. Two were in nursing h o m e s and evaluated according to definitions described by
one was in prison. Engh et al. [14]. Proximity of the c o m p o n e n t to
within 1 m m of endosteal bone was identified
Clinical Evaluation in each zone, and anteroposterior fill of the
medullary bone by the c o m p o n e n t was measured
Pain and function were assessed by a certified at the junction of zones I and II and expressed as a
physical therapist using a Harris hip rating before and percentage. The primary sign of c o m p o n e n t insta-
1, 2, 5, and 7 years after surgery. Scores of 90 to 100 bility was subsidence of 5 m m or greater; con-
were considered to be excellent; 80 to 89, good; 70 to versely, the absence of subsidence was considered a
79 fair; and under 70, poor results. The patients were sign of probable c o m p o n e n t stability. Other signs
questioned about the presence or absence of groin suggestive of instability were calcar hypertrophy,
and thigh pain at each clinical visit. distal pedestal formation, and the development of
progressively widening radiolucent lines a r o u n d
Radiographic Analysis the c o m p o n e n t [16]. Complete radiolucencies in
I n d e p e n d e n t radiographic analysis was provided the porous-coated area (zone I) were considered
by an unbiased reviewer (J.M.) at a different insti- signs of failure of bony ingrowth (ie, fibrous fixa-
tution w i t h o u t knowledge of patients' clinical tion). Probable failure of ingrowth (probable
scores. Each patient had an anteroposterior radio- fibrous fixation) was likely if the radiolucency
graph of the pelvis and hip and frog-leg lateral encompassed more t h a n 50% of the interface on
radiographs of the hip performed before surgery zone I. The presence of spot welds in zone I
and, t h e n after surgery at 6 weeks, 1, 2, 5, and 7 denoted fixation of the c o m p o n e n t by bone
years. Magnification correction factors were calcu- ingrowth [14]. Representative radiographs of an
lated for each film based on the ratio of the mea- Integral femoral stem, 10 years after surgery, with
sured diameter of the prosthetic head to the actual a revised acetabular cup, 6 years postrevision, are
k n o w n diameter. The immediate postoperative and shown in Figures 2 and 3.
most recent follow-up radiographs were reviewed
for signs of femoral and acetabular c o m p o n e n t
failure. Because the focus of the study was the
femoral stem components, the radiographic analy-
sis of the acetabular c o m p o n e n t s is not included in
this report.
Preoperative radiographs were evaluated for Dorr
bone subtype [10]. Postoperative films were evalu-
ated for ectopic bone according to the Brooker et al.
classification [11]. Femoral component position was
assessed using a fixed point of reference on the pros-
thesis and the femur (using the lesser trochanter).
Subsidence was present if the c o m p o n e n t settled 5
m m or more. Component orientation was neutral if
the center lines of the c o m p o n e n t and femur were
within 3°; otherwise, the c o m p o n e n t was designated
as either varus or valgus.
All changes a r o u n d the cementless femoral com-
p o n e n t were d o c u m e n t e d using a system modified
from that suggested by Engh et al. [12-14]. The
femoral interface was divided in two zones. Zone I
was defined as the area a r o u n d the porous surface
of the femoral component; zone II was distal
a r o u n d the smooth part of the stem [15]. Calcar
changes (atrophy or hypertrophy), radiolucent
lines, endosteal n e w bone formation near the pros- Fig. 2. Anteroposterior view of lO-year postoperative
thesis (spot welds), presence of a distal pedestal (an Integral femoral stem with a 6-year postoperative
intramedullary shelf of n e w bone at the distal tip of acetabular cup revision. Large arrows, distal endosteal
the prosthesis), and cancellous bone changes were bone growth; small arrows, proximal spot welds.

Fig. 3. Frog-leg lateral view of 10-year postoperative Inte-
gral femoral stem with a 6-year postoperative acetabular
cup revision. Arrows, distal endosteal bone growth.
Statistics
Comparisons between pre- and postoperative vari-
ables were performed using the two-tailed, paired t-
test. Differences were considered to be significant at
P < .05.
Results
The average preoperative pain score was 19.9
(range, 0-40), increasing to 41.8 (range, 20-44) at
1 year (P < .0001) and 41.2 (range, 10-44) at the
most recent follow-up visit (P < .0001). The aver-
age preoperative function score was 55.6 (range,
12-84), increasing to 92.3 (range, 58-100) at 1
year (P < .0001), and 93.5 (range, 6 - I 0 0 ) at the
most recent follow-up visit (P < .0001) (Table 2).
Excellent and good results were obtained in 139
Table 2. Clinical R a t i n g s of the I n t e g r a l S t e m
Harris Hip Score
Preoperative 1 Year Most Recent*
Pain 19.9 41.8 41.2
Function 55.6 92.3 93.5
*Mean follow-up period was 5.8 years; range, 5-8 years.
Integral Porous Femoral Stem • Mauerhanetal. 253
hips (94%). Nine hips (6%) had fair or poor
results; however, of those hips, 4 hips (3%) were
rated just prior to revision surgery of a failed
acetabular c o m p o n e n t . At the most recent follow-
up visit, the incidence of thigh pain was 4%. In
these patients the thigh pain was present after long
periods of activity and was disabling in none.
Thirty-seven hips (25%) had a revision of the
acetabular cup. Thirty-two (22%) that were revised
for acetabular cup loosening had threaded acetabu-
lar components and 5 hips (3%) had a porous hemi-
spherical cup with adjuvant screws. The use of 28
and 32-mm titanium femoral heads as well as thin
polyethylene liners with first-generation locking
mechanisms contributed significantly to these fail-
ures. In this series, the average time to acetabular
failure was 5.3 years (range, 2-8 years). Of the 37
acetabular failures, 21 of 37 (57%) had an element
of acetabular osteolysis contributing to failure. At
the time of acetabular revision, no femoral compo-
nent showed radiographic evidence of loosening,
and intraoperative evaluation of the femoral compo-
nent found it to be solidly fixed and stable. The
return of the pain and function scores to excellent
and good results after acetabular revision was
reflected in the most recent clinical evaluation.
Deteriorating clinical scores during the follow-up
period represented impending acetabular failure. To
date, none of the femoral components have been
revised or showed signs of aseptic loosening.
Radiographic Analysis
There were 46 hips (31%) with a Dorr bone type
A, 98 hips (66%) with a Dorr bone type B, and 4
hips (3%) with a Dorr bone type C. Femoral subsi-
dence of 5 m m or more was seen in 2 hips (1.4%);
however, these two subsidence events were 5 m m
and both demonstrated spot welds and no distal
pedestals. In the porous-coated zone (zone I), spot
welds were present in 147 (99.3%). Only 2 (1.4%)
had radiolucencies that constituted greater than
50% of the porous-coated zone. These two hips
probably had fibrous fixation. Distal pedestals
could be identified in 13 (9.0%). Direct bone appo-
sition in this zone was apparent. Distal cortical
h y p e r t r o p h y in zone II was seen in 42 (28.6%).
Calcar atrophy was absent in 32 hips (22%), pres-
ent above the lesser trochanter in 96 hips (65%),
and to the level of the lesser trochanter in 13 hips
(13 %). Radiographic evaluation demonstrated no
evidence of aseptic loosening.
Measurable osteolytic defects were seen in only
two patients. One patient developed a defect in the
greater trochanter at 6 years. This patient subse-
254 The Journal of Arthroplasty Vol. 12 No. 3 April 1997
quently had a revision of a failed threaded acetabular
component and grafting of a 2 x 3-cm defect. The
second patient developed a defect in the region of
the calcar and lesser trochanter at 6 years. This
patient also had a revision of a threaded acetabular
component without grafting of the calcar defect.
There were no cases of distal osteolysis at the time of
this report.
The anteroposterior fill ratio had a m e a n of 0.81
(range, 0.54-0.95). On the a n t e r o p o s t e r i o r radio-
graph, 94.6% of patients w e r e judged to have an
excellent fit. On the lateral radiograph, only
67.3% were judged to have an excellent fit. There
was no correlation b e t w e e n fit and fill and radio-
graphic c o m p o n e n t migration or change in varus
or valgus position. Additionally, there was no cor-
relation b e t w e e n fit and fill, Dorr b o n e type, and
clinical outcome.
Discussion
Cenrentless fixation of the femoral c o m p o n e n t in
THA can be achieved with stems of different geom-
etry, metallurgy, porous coatings, and surface treat-
ments. The degree to which each of these variables
contributes to initial fixation and long-term dura-
bility continues to be elucidated as intermediate
studies are published. Studies have attempted to
define the ideal stem geometry for cementless fixa-
tion [17]. Others have explored the nature of
porous coatings [i8]. Still others have espoused
the benefits of bioactive coatings such as hydroxya-
patite [ 19-21 ].
Certainly, long-term studies will clarify which
variables promote the durability of THA as well as
those that are detrimental, such as titanium femoral
heads [22] and thin polyethylene liners [23-26]. If
long-term studies show equivalency of these vari-
ables, then issues such as cost and ease and repro-
ducibility of implantation will assume a major role
in decisions of implant choice and fixation method.
This study demonstrates several points. First, the
femoral c o m p o n e n t design used, a tapered wedge
with a proximal plasma spray coating, allowed
excellent initial implant stability, with 98% radio-
graphic bone ingrowth at 5 to 8 years. The two
stems with radiographic fibrous fixation had no
progressive changes and excellent clinical function.
Secondly, titanium plasma spray surface treatment
facilitates osseointegration of the implant radio-
graphically in a predictable fashion. Although diffi-
cult to quantitate, endosteal bone apposition can be
demonstrated in zone II of the series on both the
anteroposterior and lateral radiographs. This adap-
tive remodeling combined with a 99% incidence of
spot welds seen in zone I (the porous c o a t i n g ) -
without incidence of deterioration of the bone-pros-
thesis interface--is an encouraging finding.
Third, it is conceivable that the absence of distal
osteolysis is related to the circumferential titanium
plasma spray coating that may serve to inhibit distal
transfer of particulate debris. Even though we did
not observe distal osteolysis in this series, however,
we do agree that caution must be exercised w h e n
predicting h o w the bone-prosthesis interface will
change over longer periods, given the constant
assault of particulate debris. The presence of oste-
olytic defects in the calcar region, particularly under
the collar, may be underestimated in this study. In
our series, it is c o m m o n to find a small (< 1 cm)
scalloped lesion in the region of the lesser trochanter
at the time of revision of failed acetabular compo-
nents. These lesions are clearly demarcated by a
sclerotic bony rim that is firmly attached to the pros-
thesis, without distal extension.
This study emphasizes the n e e d for c o n t i n u e d
periodic follow-up evaluation in THA. There was a
25% acetabular failure rate, and it is anticipated
that this will increase with time as more cases
of asymptomatic and symptomatic periacitabular
osteolysis are discovered. After an initial excellent
and good period of function, we found the deteri-
oration of clinical scores in this series was uni-
formly attributable to impending acetabular fail-
ure at an average time of 5.3 years from initial
implantation. Femoral c o m p o n e n t s in this series
all s h o w e d evidence of osseointegration and stable
fixation which was maintained t h r o u g h o u t the
period of acetabular failure and eventual revision.
Because radiographic acetabular failure preceded
clinical failure in m a n y cases, the need for con-
tinued long-term follow-up evaluations of all
patients is necessary, a fact that should be continu-
ally expressed to patients, third-party payors, and
health policy analysts.
Conclusion
We believe these results demonstrate that a
femoral c o m p o n e n t with design parameters set
forth in this paper gives excellent clinical and
radiographic results in the intermediate follow-up
period of 5 to 8 years. The issues of durability and
preservation of the bone-prosthesis interface will
be further elucidated with time.
Acknowledgment
We t h a n k Dr. William J. Hozack of The R o t h m a n
Institute (Philadelphia, PA) for his help in the

radiographic interpretations and a n a l y s i s of t h e
Integral femoral stem.
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