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Survival Analysis of Hips Treated with Core Decompression or Vascularized Fibular Grafting Because of Avascular Necrosis*

SEAN P. SCULLY, M.D., PH.D., DURHAM, ROY K. AARON, M.D., PROVIDENCE, RHODE ISLAND and JAMES R. URBANIAK, M.D., DURHAM, NORTH CAROLINA

Investigation performed at Duke University Medical Center, Durham, and Brown University School of Medicine, Providence

	Abstract

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Avascular necrosis of the femoral head is a multifaceted process that leads to articular incongruity and subsequent osteoarthrosis of the joint. Clinicians concur that primary treatment should focus on preservation of the natural surface of the joint; however, there has not been a consensus on how best to accomplish this. While a number of therapeutic interventions have been reported, the efficacy has varied markedly and there have been few statistical comparisons. The purpose of the current study was to use statistical analysis to compare the results of two widely used procedures, vascularized fibular grafting (614 hips; 480 patients) and core decompression (ninety-eight hips; seventy-two patients), for the treatment of avascular necrosis. The patients were stratified according to age and the stage of disease, and a survival analysis was performed with total hip arthroplasty as the end point for failure. None of the eleven hips that had Ficat stage-I disease needed a total joint replacement after being treated with either regimen. Analysis of the hips that had stage-II disease revealed rates of survival, at fifty months, of 65 per cent (twenty-eight of forty-three hips) after core decompression and 89 per cent (ninety-nine of 111 hips) after vascularized fibular grafting. For the hips that had Ficat stage-III disease, the rates of survival at fifty months were 21 per cent (ten of forty-seven hips) after core decompression and 81 per cent (405 of 500 hips) after vascularized fibular grafting. Among the hips that had Ficat stage-II or III disease, the rate of eventual total joint arthroplasty after vascularized fibular grafting was significantly lower than that after core decompression (p < 0.0001). The results indicate that the increased morbidity associated with vascularized fibular grafting is justified by the associated delay in or prevention of articular collapse in hips that have stage-II or III disease.

	Introduction

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Avascular necrosis of the femoral head is probably the result of multiple etiologies, each of which culminates in a loss of subchondral support of the articular surface, which leads to collapse and subsequent osteoarthrosis of the joint. This disorder generally affects patients who are younger than fifty years, in whom joint replacement should be avoided. Clinicians have managed these patients with restricted weight-bearing; core decompression^{11,19,21,23,25,26,33,34}; osteotomy^31,43-46; non-vascularized structural grafts^4,5,8,30; electrical stimulation^3,36-38; and, more recently, vascularized bone grafts^{6,7,9,13-16,49}. Because of the small number of patients managed in many centers and the numerous factors that contribute to the outcome of the disease, reports in the literature have been disparate with respect to the efficacy of these procedures. Few investigators have attempted to compare treatment methods and therefore an accepted treatment algorithm has not emerged.

Ohzono et al. reported progression to articular collapse in 68 per cent (seventy-eight) of 115 hips in which avascular necrosis had been treated non-operatively²⁹. Stulberg et al. reported such progression in eight of twelve hips that had been randomized to non-operative treatment⁴¹. Mont and Hungerford reviewed the current literature regarding non-operative therapy and found that only 180 (22 per cent) of 819 hips had a satisfactory clinical result²⁴. These clinical series clearly demonstrate that the natural history for most hips that have avascular necrosis is one of progression to articular collapse and subsequent osteoarthrosis. Therefore, intervention that either delays or prevents articular collapse would be of substantial benefit.

Core decompression was originally described as a diagnostic procedure, but it was later proposed that the procedure has therapeutic benefit². It gained popularity because of early promising results, low morbidity, and a paucity of alternative treatments. Core decompression is thought to relieve the compression caused by the interstitial edema, improve vascularity, and slow the progression of necrosis within the femoral head¹². The decrease in intraosseous pressure may result in marked relief of pain. The reported efficacy of this procedure varies widely. Koo et al. reported progression in fourteen of eighteen hips that had had core decompression¹⁹, and Mont et al. reported progression of the necrosis in 434 (36 per cent) of 1206 hips²⁵. Stulberg et al. compared core decompression with non-operative treatment and reported radiographic progression of the necrosis in nine (31 per cent) of twenty-nine hips that had been treated with core decompression compared with twenty (77 per cent) of twenty-six hips that had been treated non-operatively⁴¹. However, survivorship analysis of a large cohort managed with core decompression indicated a 57 per cent rate of survival (seventy-three of 128 hips) at ten years¹¹. One of us (R. K. A.) and colleagues reported radiographic progression of the necrosis in thirty-two (64 per cent) of fifty hips that had been treated with core decompression but in only twenty-two (39 per cent) of fifty-six hips that had been treated with pulsed electromagnetic-field stimulation¹.

Strut-grafting procedures, as originally described by Phemister³⁰, had encouraging early clinical results in the few studies that were reported^4,5,8, but the clinical outcome was found to decline markedly with longer follow-up^27,32.

Vascularized fibular grafting involves a procedure similar to that described by Phemister³⁰, but vascularized grafting introduces a source of mesenchymal stem cells and a vascular supply in addition to a structural bone graft that provides articular support^{7,13,16,22,47,50}. It is difficult to compare the results of vascularized strut-grafting with those of non-vascularized strut-grafting because of the small numbers of patients in reports on the latter procedure^4,5,8,30. More recently, the results of a large series of patients who had vascularized fibular grafting to treat avascular necrosis were reported by the senior one of us (J. R. U.) and colleagues; however, a historical control group was not available for comparison⁴⁷. The complexity of the procedure, the operative duration, and the prolonged postoperative rehabilitation have been reported⁴⁷.

The purpose of the present study was to perform a cohort statistical analysis, with multiple regression to control for covariates, in order to compare the clinical results of vascularized fibular grafting (614 femoral heads) with those of core decompression (ninety-eight femoral heads) carried out at another institution.

	Materials and Methods

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Databases that had been independently and prospectively developed at two centers were used in this study. In one of the centers avascular necrosis is traditionally treated with core decompression, and in the other it is traditionally treated with vascularized fibular grafting. The information in the databases included the stage of the disease at the time of presentation according to the system of Ficat¹²; the age and gender of the patient; the etiology of the disease; the date of the index procedure; and the date of subsequent procedures, including replacement arthroplasty. The specifics of the operative procedures and subsequent clinical care have been documented previously^1,47.

Between August 6, 1979, and December 29, 1995, 1028 hips (712 patients) were treated with vascularized fibular grafting for avascular necrosis of the femoral head at Duke University. Two hundred and thirty-two patients who were less than eighteen years old, had Ficat stage-IV disease, or had been followed for less than twenty-one months were excluded. Thus, 614 hips (480 patients) were included in the analysis. Observations were truncated at fifty months postoperatively to permit statistical comparison with the other treatment group. Of the 614 hips, 500 were Ficat stage III, 111 were stage II, and three were stage I. The average age of the 350 men and 130 women was thirty-five years (range, eighteen to sixty years). The etiology of the avascular necrosis was the excessive consumption of alcohol in 104 patients, idiopathic in 122, the use of steroids in 153, posttraumatic osteoarthrosis in seventy-nine, and another cause (such as Legg-Calvé-Perthes disease, caisson disease, pregnancy, lupus erythematosus, sickle-cell disease, or radiation) in twenty-two.

Ninety-eight hips (seventy-two patients) had a core decompression performed at Brown University during the same time-period as the vascularized-graft procedures were done. Forty-seven hips were Ficat stage III, forty-three were stage II, and eight were stage I. The average age of the thirty-two men and forty women was forty-one years (range, eighteen to sixty-six years). The etiology of the avascular necrosis was the excessive consumption of alcohol in seventeen patients, idiopathic in seven, the use of steroids in forty, posttraumatic osteoarthrosis in one, and another cause in seven.

Patients were stratified according to the Ficat stage of the disease¹², and a parallel analysis was performed for patients who had stage-II disease and those who had stage-III disease. Survival, with total hip arthroplasty as the end point, was compared between the groups with use of the Kaplan-Meier method¹⁷ and log-rank survival analysis. A Cox proportional-hazards model¹⁰ was then used to determine the effects of covariates such as age and etiology. Failure was defined as conversion to total hip arthroplasty. The patients were followed for a minimum of twenty-one months, and observations were truncated at fifty months to permit statistical analysis.

	Results

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The two treatment groups differed markedly with respect to the ages of the patients who had stage-II disease (p = 0.081), and they differed significantly with respect to the ages of the patients who had stage-III disease (p = 0.001). In both instances, the patients who had vascularized fibular grafting were younger than those who had core decompression. There also was a difference in the distribution of Ficat stages between the two treatment groups; however, because the statistical comparison stratified the patients by stage the results were not biased by this parameter. In addition, there was a marked difference in the spectrum of etiologies between the two treatment groups; however, others²⁴ have shown that etiology is not an important prognostic indicator for the patients who have avascular necrosis and this variable was not considered in the statistical modeling.

Eight of the hips that had stage-I disease were treated with core decompression, and the other three were treated with vascularized fibular grafting. None of the stage-I hips were eventually treated with total hip arthroplasty.

Only twelve (11 per cent) of the 111 stage-II hips that had been treated with vascularized fibular grafting eventually had a total hip arthroplasty compared with fifteen (35 per cent) of the forty-three stage-II hips that had been treated with core decompression. At fifty months, the rate of survival of the stage-II hips that had been treated with vascularized fibular grafting was 89 per cent compared with 65 per cent of those that had been treated with core decompression (Fig. 1). Log-rank analysis indicated that this difference was significant (p < 0.0001). Increasing age was related to increased risk of total hip arthroplasty in the patients who had stage-II avascular necrosis (risk ratio = 1.055). While the patients who were managed with core decompression were markedly older than those who were managed with vascularized fibular grafting, analytical adjustment for this bias through the use of age as a covariate in a Cox proportional-hazards model still showed a highly significant difference in survival due to the procedure, independent of the bias due to the older age of the patients managed with core decompression (p = 0.0025; risk ratio = 3.63).

View larger version (15K): [in this window] [in a new window]   FIG1: Figs. 1 and 2: Kaplan-Meier survivorship curves17, with total joint replacement as the end point, for hips in which avascular necrosis was treated with either vascularized fibular grafting (line 2) or core decompression (line 5). Lines 1 and 3 represent the 95 per cent confidence intervals for the hips that were treated with vascularized fibular grafting. Lines 4 and 6 represent the 95 per cent confidence intervals for the hips that were treated with core decompression. Log-rank analysis indicated a significant difference in the results of treatment (p < 0.0001). Fig. 1: Hips that had Ficat stage-II disease.

View larger version (17K): [in this window] [in a new window]   FIG2: Fig. 2 Hips that had Ficat stage-III disease.

	Discussion

Top Abstract Introduction Materials and Methods Results Discussion References

 
While the natural history of avascular necrosis of the femoral head is related to several factors, including the age of the patient, the extent of involvement of the weight-bearing dome, and the etiology, most clinicians concur that hips that have radiographic evidence of disease usually progress to articular collapse and subsequent osteoarthrosis. The treatment options for these hips are limited, and none is completely satisfactory. We compared the outcomes from two centers, one in which vascularized fibular grafting is used and one in which core decompression is used, to determine if the outcome justified the added morbidity associated with vascularized fibular grafting. Both the stage of the disease and the age of the patient have been reported as significant variables in the successful of treatment of avascular necrosis of the femoral head^1,47. Our comparison stratified patients according to Ficat stage¹², and a statistical correction was made for the differences in age between the two treatment groups. We were not able to stratify patients according to the extent of involvement of the femoral head, which has also been demonstrated to influence outcome^{16,18,20,25,28,35,40,42,49}. Therefore, unrecognized differences between the patients in the two groups may have influenced the statistical results. Other parameters, such as gender and etiology, have not been shown to be prognostically important²⁴.

Vascularized fibular grafting is a complex procedure, which has been refined during the previous thirteen years by the senior one of us (J. R. U.), and it involves two teams of surgeons who have experience with microvascular techniques⁴⁷. The procedure has resulted in improved function and a high degree of patient satisfaction. The patient is allowed only protected weight-bearing for six months postoperatively. The procedure may be associated with complications. In one study that included 247 lower limbs, seventy-four of which had been followed for five years or more, Kaplan-Meier analysis revealed a prevalence of pain at the donor site of 11.5 per cent at five years and a prevalence of neurological motor deficit at the donor site of 2.7 per cent at five years⁴⁸. Subtrochanteric fracture also may occur.

Only eleven hips in the present study had stage-I disease; eight were treated with core decompression and three, with vascularized fibular grafting. None of these hips progressed to total joint replacement. In a review of twenty-one studies that included a total of 559 non-operatively treated hips with avascular necrosis for which radiographs were available, Mont and Hungerford reported that the femoral head was not preserved in 65 per cent of the stage-I hips (the number of stage-I hips was not given)²⁴. In a study of the results of treatment of osteonecrosis of the femoral head with core decompression, the rate of failure for thirty-two hips that had stage-I disease was 41 per cent (thirteen)³³. The results of the present study suggest that either core decompression or vascularized fibular grafting may be satisfactory treatment for stage-I disease if, in fact, operative intervention is indicated. However, the number of stage-I hips in the current study is small, and the results for them may not be different from those for historical controls.

Reports of successful treatment of avascular necrosis with core decompression have suggested that this technique could markedly alter the natural history of the disease process¹². The 35 per cent rate of failure of core decompression for the forty-three hips that had stage-II disease and the 79 per cent rate of failure for the forty-seven hips that had stage-III disease are similar to those reported in other large series in which this treatment method was used^{1,11,19,23,25,26,33,34,39}; however, they differ from the 64 per cent rate of success (741 of 1166 hips) reported in a comprehensive review of the literature²⁴. The median time to failure in our series was twenty-seven months. The early acceptance of core decompression has led others to compare the results of alternative treatments with those of core decompression as a means of establishing the efficacy of core decompression^1,16,25,38.

The group of patients managed with vascularized fibular grafting in the current study represents an expansion of a previously reported group of the first 103 hips treated with this procedure at Duke University and followed for a minimum of five years⁴⁷. The rate of survival did not change with the inclusion of more patients. The results of the present study compare favorably with other reported results of this treatment method^6,50 and dramatically demonstrate that stage-II or III hips that are treated with vascularized fibular grafting have a lower rate of subsequent total joint arthroplasty than do those that are treated with core decompression. These results are very similar to those reported by Kane et al., who performed a randomized, prospective study that included thirty-nine hips¹⁶. Those authors reported failure in eleven of nineteen hips that were treated with core decompression and in four (20 per cent) of twenty hips that were treated with vascularized fibular grafting.

In the case of stage-I avascular necrosis of the femoral head, it appears that core decompression may improve the outcome as effectively as vascularized fibular grafting. In the case of stage-II or stage-III disease, the outcome is better (p = 0.001) after vascularized fibular grafting than after core decompression. There are probably many reasons for the differences in outcome between the two groups, but these reasons probably do not include differences in the selection of patients or in the patients' compliance with the postoperative protocol because the groups were drawn from the entire population of patients managed at each institution. The benefit of performing vascularized fibular grafting with core decompression may be a function of either the addition of structural support to the articular surface or the introduction of a vascular supply and a source of mesenchymal stem cells, or both. This reconstructive method can decrease morbidity by either delaying or preventing progression of the avascular necrosis so that total joint arthroplasty is not necessary.

NOTE: The authors acknowledge the cooperation of Dr. Dennis Lenox and Dr. Bernard Stulberg.

	Footnotes

 
*No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. No funds were received in support of this study.

Duke University Medical Center, Boxes 3312 (S. P. S.) and 2912 (J. R. U.), Durham, North Carolina 27710. E-mail address for Dr. Scully: scull00@2mc.duke.edu.

Brown University School of Medicine, Southwest Pavilion 524, 593 Eddy Street, Providence, Rhode Island 02903.

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