We performed a retrospective review of fifty-four patients (sixty
consecutive hips) in whom a porous tantalum implant (Trabecular Metal; Zimmer
Trabecular Metal Technology, Allendale, New Jersey) was inserted to treat
osteonecrosis of the femoral head (Figs.
1-A through 1-D). The biomechanical properties of the porous
tantalum implant have been previously described in
detail19,20,23.
All procedures were performed by a single surgeon (M.D.M.) between November 1,
2001 and September 15, 2005. Procedures were performed for symptomatic
patients who had radiographically documented osteonecrosis of the femoral head
without articular surface depression and who were sixty-five years of age or
younger (mean age, thirty-five years). Two patients (two hips, 3%) were lost
to follow-up early (at six weeks after the operation) because they were from
remote provinces. Both patients had improvement in their symptoms and no
evidence of clinical or radiographic complications. All patients received a
comprehensive evaluation that included preoperative medical history, physical
examination, and anteroposterior and lateral radiographs. The data recorded
included age at presentation, gender, associated risk factors, and, for hips
with more advanced disease, the presence of contralateral hip resurfacing or
total hip arthroplasty. The initial stage and the extent of involvement of the
femoral head were assessed radiographically according to the classification
system of Steinberg et
al.24-27.
Outcome measures included Harris hip scores, radiographic staging of the hip,
adverse events, and survival analysis, with total hip arthroplasty as the end
point for failure. Patients who had persistent pain and limitation in function
and who were not satisfied with the outcome following tantalum rod insertion
were assessed by a single surgeon (E.H.S.) for conversion to total hip
arthroplasty.
Demographics
Fifty-two patients (fifty-eight hips with tantalum implants) were available
for follow-up at an average of twenty-four months (range, six to fifty-two
months). Four patients (four hips) from remote areas had only radiographic
follow-up (sent by local physicians). Thirty-five patients were men and
seventeen were women. The average age at the time of the index procedure was
thirty-five years (range, twelve to sixty-four years). Twenty-five patients
(48%) had bilateral involvement, including six patients who received a porous
tantalum implant bilaterally, eleven patients who received a porous tantalum
implant on one side and had had a previous contralateral total hip
arthroplasty or resurfacing procedure, and one patient who received a porous
tantalum implant on one side and had a contralateral vascularized fibular
grafting. As of writing, seven patients are awaiting treatment for the
opposite hip. The associated risk factors included corticosteroid use in
twenty-two patients (twenty-six hips), excessive alcohol consumption in two
patients (two hips), none known in thirteen patients (fifteen hips), trauma in
six patients (six hips), and other factors in nine patients (nine hips).
Systemic lupus erythematosus was the reason for the use of steroids in nine
patients (eleven hips). Evaluation of preoperative radiographs for the stage
of disease according to the Steinberg classification indicated that one hip
(2%) had stage-I disease, forty-nine hips (84%) had stage-II disease, and
eight hips (14%) had stage-III disease.
Operative Technique
The procedure was performed with the patient in the lateral decubitus
position with the affected hip prepared and draped freely. Fluoroscopy was
used to project the planned trajectory of implant insertion onto the skin, and
a 2.5-cm mid-lateral longitudinal incision was made. The fascia lata and the
vastus lateralis muscle were split in the direction of their fibers down to
the lateral aspect of the proximal part of the femur. With use of fluoroscopic
guidance, the guidewire was then placed into the center of the osteonecrotic
lesion, typically in the anterosuperior portion of the femoral head. Core
decompression, under fluoroscopic guidance and with use of three cannulated
reamers (8, 9, and 10 mm), was then used to remove bone up to the subchondral
level. The length of the guidewire was then measured, and the
core-decompression hole was tapped. Next, the 10-mm porous tantalum rod was
inserted under fluoroscopic guidance until the implant abutted the subchondral
plate. The incision was closed in layers. Patients remained in the hospital
overnight and were told to remain non-weight-bearing with use of crutches for
six weeks. Patients were then started on a strengthening physiotherapy
protocol and allowed to progress to full weight-bearing as tolerated.
Statistical Methods
Statistical analysis of the data was performed with use of Statistical
Package for the Social Sciences (SPSS) software (version 13.0 for Windows;
SPSS, Chicago, Illinois). The Student t test was used for the comparison of
means for parametric scale variables in independent groups. Nominal variables
were tested with use of the chi-square test or the Fisher exact test. A
Kaplan-Meier survivorship analysis, with revision to total hip arthroplasty as
the end point, was performed. A comparison of Kaplan-Meier curves for
stratified factors was performed with the log-rank test (Mantel-Cox).
Multivariate analysis was performed with use of the Cox proportional-hazards
model with censoring to identify the independent prognostic factors associated
with clinical and radiographic failure. All tests were two-sided. The results
were considered to be significant at p < 0.05.
Hip Scores
The average postoperative Harris hip score for the fifty-four hips
available for clinical evaluation at a mean of twenty-four months was 80
points (range, 55 to 96 points). Overall, nine hips were scored as excellent
(91 to 100 points); eighteen hips, good (81 to 90 points); seventeen hips,
fair (70 to 80 points); and ten hips, poor (<70 points). According to the
preoperative stage of the disease, hips with stage-I or II disease (n = 47) at
the time of surgery had a mean score of 81 points (range, 55 to 96 points
[nine excellent, seventeen good, fourteen fair, seven poor]), whereas hips
with stage-III disease (n = 7) had a mean score of 72 points (range, 60 to 90
points [one good, three fair, three poor]) (p = 0.07). With the numbers
studied, an analysis of the hip scores according to associated risk factors
(corticosteroid use, trauma, excessive alcohol intake, or idiopathic origin)
did not show any significant difference with regard to the Harris hip scores;
however, hips in patients with chronic systemic disease (systemic lupus
erythematosus, Wegener granulomatosis, human immunodeficiency virus, or
hepatitis) had a significantly lower average hip score (73 points; range, 55
to 95 points [one excellent, three good, five fair, six poor]) than hips in
patients without chronic systemic disease (82 points; range, 60 to 96 points
[eight excellent, fifteen good, twelve fair, four poor]) (p = 0.01).
Radiographic Progression
Radiographic progression occurred in sixteen of the fifty-eight hips (28%)
after insertion of the porous tantalum implants. Thirteen stage-II hips showed
progression on the preoperative radiographs: eight hips progressed to stage
III, three hips showed flattening of the femoral head with depression (stage
IV), and two hips showed joint-space narrowing (stage V). Two stage-III hips
showed progression on follow-up radiographs: one hip progressed to stage V,
and one hip showed advanced degenerative changes consistent with stage VI.
Overall, seven of sixteen hips (43.8%) that had radiographic progression had
conversion to a total hip arthroplasty, whereas only two of forty-two hips
(4.8%) in patients without radiographic progression required conversion to a
total hip arthroplasty (odds ratio = 15.8; 95% confidence interval, 2.7 to
87.7; p = 0.001). A comparison of Kaplan-Meier curves showed significantly
higher survival rates (p = 0.002) for hips without radiographic signs of
progression (94% at forty-eight months; 95% confidence interval, 89.9% to
98.1%) than in patients with radiographic signs of progression (36.6% at
forty-eight months; 95% confidence interval, 19.1% to 54.1%)
(Fig. 2).
Conversion to Total Hip Arthroplasty
Nine hips (15.5%) were converted to a total hip arthroplasty at an average
of eighteen months (range, ten to forty-five months) after insertion of the
porous tantalum implant. The primary indication for reoperation was pain in
eight patients. One patient with chronic hepatitis had development of a deep
infection and required a two-stage conversion to a total hip arthroplasty. The
patients who had a revision included four men and five women (average age,
thirty-six years; range, nineteen to sixty-four years). The preoperative
associated risk factors were corticosteroid use for seven of these hips and
none known for two hips.
Six (12%) of the hips with stage-II disease were converted to total hip
arthroplasty, and three (38%) of the stage-III hips required conversion to
total hip arthroplasty. The one stage-I hip did not need a total hip
arthroplasty. The Kaplan-Meier survivorship analysis for all hips
(Fig. 3) showed that the
probability for not requiring revision to total hip arthroplasty after
insertion of a porous tantalum implant was 91.8% (95% confidence interval,
87.8% to 95.8%) at twelve months, 81.7% (95% confidence interval, 75.8% to
87.6%) at twenty-four months, and 68.1% (95% confidence interval, 54.7% to
81.5%) at forty-eight months. Six of fifteen hips (40%) in patients with
chronic systemic disease (systemic lupus erythematosus, Wegener
granulomatosis, human immunodeficiency virus, or hepatitis) required
conversion to total hip arthroplasty, whereas only three of forty-three hips
(7%) in patients without chronic systemic disease required conversion to total
hip arthroplasty (odds ratio = 8.9; 95% confidence interval, 1.9 to 42.4; p =
0.006). A comparison of Kaplan-Meier curves showed significantly higher
survival rates (p < 0.001) for hips in patients without chronic systemic
diseases (91.9% at forty-eight months; 95% confidence interval, 80.9% to
95.1%) than in patients with chronic systemic diseases (22.9% at forty-eight
months; 95% confidence interval, 4.7% to 41.1%)
(Fig. 4). In addition, in
comparison with stage-II hips, there was a trend for stage-III hips to more
likely require conversion to total hip arthroplasty (p = 0.18). With regard to
underlying risk factors, there was a trend toward worse survival rates for
hips with corticosteroid-induced osteonecrosis than for hips with idiopathic
or other causes of osteonecrosis (p = 0.10). Four of eleven hips (36%) in
patients with systemic lupus erythematosus required conversion to total hip
arthroplasty, whereas only five of forty-seven hips (11%) in patients without
systemic lupus erythematosus required conversion (odds ratio = 4.8; 95%
confidence interval, 1.03 to 22.4; p = 0.05). With the numbers studied, no
significant differences were found among the survivorship curves when
stratified for bilateral disease (p = 0.57), age greater than fifty years (p =
0.78), and gender (p = 0.20).
The Cox proportional-hazards model revealed that chronic systemic disease
was an independent prognostic factor related to conversion to total hip
arthroplasty (hazard ratio, 4.5; 95% confidence interval, 1.03 to 19.79; p =
0.046). However, in the univariate or multivariate analyses, with the numbers
available for study, no significant relationship was found between conversion
to total hip arthroplasty and such factors as corticosteroid use, age over
fifty years, gender, or bilateral disease. In addition, the use of
corticosteroids was found to be an independent predictor of radiographic
progression, regardless of the stage of disease (hazard ratio, 5.35; 95%
confidence interval, 1.49 to 19.24; p = 0.01).
Complications
Complications included one case of superficial infection treated
successfully with oral antibiotics, one case of deep infection managed with a
two-stage conversion to a total hip arthroplasty, and one case of trochanteric
bursitis.
There has not been a consensus on how best to reduce symptoms and slow the
progression of osteonecrosis of the femoral head. Several studies have shown
that nonoperative treatment in symptomatic patients with early stage disease
results in poor outcomes with progressive collapse in up to 80% of
patients5,6.
Numerous treatment algorithms have been proposed for early stage osteonecrosis
of the femoral head. The most common procedures include core decompression
alone or in combination with a structural vascularized fibular graft or one of
several nonvascularized bone-graft techniques. Unfortunately, the efficacy of
core decompression has varied markedly. Stulberg et al. showed that core
decompression was successful in approximately 70% of hips on the basis of
Harris hip scores5.
In contrast, Koo et al., in a randomized clinical trial, reported radiographic
signs of progression in 72% of patients treated with core decompression, and
the majority of those hips required conversion to a total hip
arthroplasty6. In a
comprehensive literature review of twenty-four studies (1166 hips) that
reported on the clinical outcome after core decompression, Mont et al.
demonstrated an overall satisfactory clinical result in 64% of hips after an
average of thirty months from core
decompression4.
Scully et al. reported that the rate of conversion to total joint arthroplasty
after vascularized fibular grafting was significantly lower than after core
decompression in hips that had stage-II or III disease. The survival rates, at
fifty months, for hips that had stage-II disease were 65% after core
decompression and 89% after vascularized fibular grafting. In hips that had
stage-III disease, the rates of survival were 21% after core decompression and
81% after vascularized fibular
grafting12.
Recently, Tsao et al. reported favorable early clinical results in a
multicentered investigational device exemption study of 113 porous tantalum
implants in ninety-eight
patients23. With
revision to total hip arthroplasty as the end point, the overall survival rate
for all stage-II hips (n = 93) was 72.5% at forty-eight months. The early
results of the present study support the results of other studies, which
indicate that, in patients without chronic systemic disease, hips treated with
a porous tantalum implant have similar or better survival rates (92% at
forty-eight months; 95% confidence interval, 87.4% to 96.4% in our study) than
hips treated with core decompression and vascularized fibular grafting.
Although vascularized fibular grafting has shown promising results in young
patients with osteonecrosis of the femoral head, there are several potential
concerns: an extensive surgical procedure, increased donor-site
morbidity15,16,
prolonged rehabilitation with protected weight-bearing for three to six
months, and the risk of proximal femoral
fracture17. Our
study has shown that insertion of the porous tantalum implant can be performed
safely and effectively through a minimally invasive technique (2.5-cm
incision) with no associated donor-site morbidity and minimal local
complications. In addition, the patients who had the minimally invasive
technique recovered more quickly than the patients of other studies who had
vascularized fibular grafts; our patients required only a single overnight
hospital stay followed by six weeks of non-weight-bearing walking with
crutches.
Several studies have examined the prognostic factors associated with
progression of collapse and subsequent osteoarthrosis despite operative
intervention for osteonecrosis of the femoral head. Numerous studies have
found that the results of core
decompression4,6-8,12,28-30
and vascularized fibular
grafting11-13
were substantially worse when there had been collapse of the femoral head
preoperatively. Although we had a limited number of hips with preoperative
collapse in our study, our results suggested a trend toward worse survival
rates in stage-III hips compared with stage-II hips.
Another important factor in patient selection has been the underlying
associated risk factors for the osteonecrosis. The results of several studies
have suggested that outcomes are worse for patients who have
corticosteroid-associated
osteonecrosis31-35.
Bozic et al.29
demonstrated an independent relationship between the use of corticosteroids
and survival of the hip in their survival analysis of hips that were treated
with core decompression for osteonecrosis. In agreement with these studies,
the present study identified the use of corticosteroids as an independent
prognostic factor for radiographic progression, regardless of the stage of the
disease.
The overall survival rate for all hips with a porous tantalum implant was
68.1% at forty-eight months. However, further analysis revealed that
two-thirds of the hips that required conversion to total hip arthroplasty were
in patients with chronic systemic diseases. In contrast, Garberina et al.
reported that, in patients with systemic lupus erythematosus, the results of
vascularized fibular grafting at a minimum duration of follow-up of two years
are similar to those in patients without this
diagnosis36.
Although we were unable to show a statistically significant difference between
the overall survival rates for hips stratified according to the diagnosis of
systemic lupus erythematosus, the odds of requiring conversion to total hip
arthroplasty were almost four times higher in patients with systemic lupus
erythematosis than in patients without that disease. A comparison of the
survivorship curves with hips stratified according to chronic systemic disease
revealed significantly improved survival rates at forty-eight months (91.9%;
95% confidence interval, 87.4% to 96.4%) in the absence of chronic systemic
disease. Furthermore, the Cox proportional-hazards model identified chronic
systemic disease as an independent prognostic factor for failure and
conversion to total hip arthroplasty.
The high failure rates in patients with chronic systemic disease may result
from multiple concurrent vascular insults (vasculitis, hyperlipidemia, or
thrombosis) and impaired bone metabolism. Systemic lupus erythematosus,
Wegener granulomatosis, and human immunodeficiency virus may have effects on
bone from associated vasculitis or antibody-mediated
thrombosis31,33,37.
In addition, these diseases often require ongoing management with
corticosteroids, which may further potentiate the osteonecrosis. Furthermore,
patients with chronic systemic disease often have bone-mineralization defects
and osteoporosis with poor bone quality. These underlying factors may present
a poor milieu for healing and prevention of collapse after porous tantalum-rod
insertion and may explain the higher failure rate in this subset of patients.
We believe that it is important to discuss with these patients the more
guarded prognosis following insertion of porous tantalum implants.
The treatment of early stage osteonecrosis of the femoral head with core
decompression and a porous tantalum implant can be accomplished with a
minimally invasive technique, no donor-site morbidity, and few major
device-related complications. For patients who do not have chronic systemic
disease, and especially for those with early stage disease, the early clinical
results from our study show encouraging survival rates and a delay in or
prevention of progressive articular collapse in hips that are treated with a
porous tantalum implant for osteonecrosis of the femoral head. ?