The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 90, Issue 6

Scientific Articles | June 01, 2008

Cementless Total Hip Arthroplasty with Alumina Bearings in Patients Younger Than Fifty with Femoral Head Osteonecrosis

Seung-Hoon Baek, MD¹; Shin-Yoon Kim, MD, PhD²

¹ Department of Orthopaedic Surgery, Catholic University of Daegu Hospital, 3056-6 Dae-Myung-4, Nam-Gu, Daegu 705-718, South Korea. E-mail address: insideMe@paran.com
² Department of Orthopedic Surgery, Kyungpook National University Hospital, 50 Sam-Duk, Jung-Gu, Daegu 700-721, South Korea. E-mail address: syukim@knu.ac.kr

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Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

Investigation performed at the Department of Orthopedic Surgery, Kyungpook National University Hospital, Daegu, South Korea

The Journal of Bone and Joint Surgery, Inc.

J Bone Joint Surg Am, 2008 Jun 01;90(6):1314-1320. doi: 10.2106/JBJS.G.00755

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Abstract

Background: There are conflicting reports with respect to the outcomes of total hip arthroplasties with ceramic bearings in young patients with osteonecrosis of the femoral head. We prospectively investigated the outcomes after cementless total hip arthroplasties with contemporary alumina bearings in patients with osteonecrosis of the femoral head in this age group.

Methods: We prospectively followed sixty patients (seventy-one hips) with a mean age of 39.1 years for an average of 7.1 years. All procedures were performed at the same institution by one surgeon, and the results were evaluated serially. The clinical evaluations included use of the Harris hip score, and activities of daily living were evaluated with use of the criteria of Johnston et al.

Results: The mean Harris hip score was 97.0 points at the time of final follow-up. Thirteen patients (fourteen hips, 20%) reported noise in the hip. Loosening or osteolysis was not observed in any hip, and no prosthesis had been revised. No hip had dislocated, and no ceramic fracture had occurred.

Conclusions: After a minimum of six years of follow-up, this cementless total hip arthroplasty with contemporary alumina bearings was found to be a promising procedure for young, active patients with osteonecrosis of the femoral head. However, we remain concerned about the long-term implications of the noise that was reported in these hips.

Level of Evidence: Therapeutic Level IV. See Instructions to Authors for a complete description of levels of evidence.

Figures in this Article

Introduction

There are conflicting reports with respect to the success of total hip arthroplasty for patients with osteonecrosis of the femoral head^1-8. These different results may originate in part from the various risk factors for osteonecrosis of the femoral head^1,8,9 and from differences in the ages of the patients. Many authors have reported suboptimal results in younger patients^10,11. Recently, advances in surgical technique and in the designs of cemented and cementless prostheses have resulted in improved outcomes of total hip arthroplasty in young patients with osteonecrosis^1-3,7. Although the early results of total hip arthroplasty with a metal-on-highly cross-linked polyethylene articulation have shown a dramatic reduction in wear in vivo, the follow-up period is still relatively short^12,13. The results of total hip arthroplasty with metal-on-metal bearings have also shown negligible wear in vivo; however, there have been reports of early periprosthetic osteolysis and loosening potentially related to metal-ion release or delayed hypersensitivity^14-17.

Alumina ceramic bearings have been reported to reduce or eliminate wear problems, and currently available ceramics have been shown to be superior to the earlier generations of ceramics used in total hip arthroplasty^18-24. In spite of the tribologic evolution of ceramics, a number of concerns still remain: the potential for ceramic fracture^{18,19,21,23,25}, fewer intraoperative modular component options^18,20, microseparation¹⁸, impingement^18,25, noise issues^25,26, and the potential for problems when a new head is inserted on an old trunion during revision^18,23.

We investigated the outcomes of a cementless total hip arthroplasty with a ceramic-on-ceramic bearing in a group of patients with osteonecrosis of the femoral head who were less than fifty years of age.

Materials and Methods

Demographics

From September 1998 to August 2001, 100 consecutive cementless total hip arthroplasties with an alumina-on-alumina bearing surface were performed in eighty-seven patients with a diagnosis of osteonecrosis who were less than fifty years old. The procedures were performed at a single institution by the same surgeon (S.-Y.K.). Sixty-five patients (seventy-six hips) had advanced osteonecrosis of the femoral head (Ficat stage III or IV²⁷). Two patients (two hips) died from conditions unrelated to the arthroplasty within two years after the surgery, and three patients (three hips) were lost to follow-up before the minimum five-year follow-up interval had elapsed. The remaining sixty patients (seventy-one hips) constituted the study cohort. There were fifty-three male and seven female patients with a mean age (and standard deviation) of 39.1 ± 6.8 years (range, eighteen to forty-nine years). The average body mass index at the time of the operation was 22.9 ± 3.0 kg/m² (range, 16.0 to 30.7 kg/m²). The mean follow-up period was 7.1 ± 1.1 years (range, six to nine years). The study was approved by our institutional review board, and all patients provided informed consent.

The underlying conditions and risk factors for osteonecrosis^1,8,9,28 that were identified included alcohol abuse(twenty-nine hips, 41%), smoking (twenty-six, 37%), corticosteroid therapy (nine, 13%), previous trauma (seven, 10%), systemic lupus erythematosus (five, 7%), diabetes (three, 4%), and gout (one, 1%). No underlying condition or risk factor was identified in twenty hips (28%). Some patients had two or more risk factors.

Prosthesis

BIOLOX forte ceramic bearing couples (CeramTec, Plochingen, Germany) were used. All patients were treated with a 28-mm modular femoral head, with a short neck in twenty-one hips, a medium neck in forty-six, and a long neck in four. The modular ceramic acetabular insert had an outer conical fit and was secured to the shell by light tapping with a plastic impactor. The shell was a cementless plasma-sprayed PLASMACUP SC (Aesculap, Tuttlingen, Germany) with a microporous pure titanium coating (PLASMAPORE; pore size, 50 to 200 µm). The mean size of the acetabular cup was 55.2 ± 2.9 mm (range, 48 to 64 mm). A cementless plasma-sprayed BiCONTACT titanium-alloy femoral component with a collarless stem (Aesculap) was inserted in all patients. The proximal one-third of the stem was porous-coated and consisted of a broad medial border, anterior and posterior support flanges, and a lateral anti-rotation wing. The tapered distal part of the stem was uncoated (Ra = 0.4 µm; Rz = 3.2 µm) (Fig. 1).

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Fig. 1: Photograph showing the PLASMACUP SC (Aesculap) and BiCONTACT (Aesculap) hip systems with the BIOLOX forte (CeramTec) alumina bearing surfaces.

Surgical Procedure

All of the procedures were performed through a conventional posterolateral approach (mean incision length, 12 cm) without a trochanteric osteotomy. Repair of the soft tissues, including the posterior capsule and the short external rotators, was routinely performed. We used no prophylaxis against thromboembolism because the prevalence of deep venous thrombosis in Korean patients without thromboprophylaxis had been reported to be low²⁹.

Clinical Evaluation

Patients were evaluated preoperatively; at six weeks, six months, and one year postoperatively; and annually thereafter on a regular basis. The clinical evaluation included a physical examination, administration of questionnaires that included queries regarding noise in the hip, and assessments of the levels of pain and activity³⁰. The Harris hip score³¹ was determined preoperatively and at each follow-up visit.

Radiographic Evaluation

Radiographs made at six weeks postoperatively were evaluated for stem alignment³², cup abduction, and cup anteversion³³. Serial radiographs were analyzed with regard to limb-length discrepancy, reactive lines around the implant³⁴, cortical hypertrophy, evidence of stress-shielding^34,35, component stability^34-36, osteolysis³⁷, and heterotopic ossification³⁸. The acetabular component was evaluated on the basis of three zones, according to the method of DeLee and Charnley³⁹, and the femoral component was divided into fourteen zones, on the basis of the criteria of Gruen et al.⁴⁰. All radiographs were evaluated independently by three orthopaedic surgeons.

Statistical Analysis

A Student t test and a chi-square test were used to compare variables. A p value of <0.05 was considered to be significant.

Results

Clinical Outcome

The mean preoperative Harris hip score (and standard deviation) was 56.8 ± 14.2 points (range, 21 to 80 points), and it improved significantly to 97.0 ± 3.3 points (range, 89 to 100 points) at the final follow-up evaluation (p < 0.001). Thirty-nine patients (forty-seven hips, 66%) could perform strenuous labor; nineteen patients (twenty-two hips, 31%), moderate labor; and two patients (two hips, 3%), light labor. Twelve patients (thirteen hips, 18%) reported mild thigh pain³⁰ during the first postoperative year that did not alter activity or work patterns; there was no pain in the remaining fifty-eight hips. The thigh pain disappeared by two years postoperatively in nine patients (ten hips), and three patients (three hips, 4%) reported persistent mild thigh pain that did not restrict activity at the time of final follow-up. The patients with thigh pain were significantly taller than those without thigh pain (171.4 cm compared with 166.8 cm, p = 0.009). They were also significantly heavier (71.4 kg compared with 62.8 kg, p = 0.004) at the time of the operation, and they had a lower final Harris hip score (94.4 points compared with 97.5 points, p = 0.006) (Table I). At the time of final follow-up, ten patients (eleven hips, 15%) were found to have a mild limp, whereas the remaining patients (sixty hips) had no limp. No patient required any kind of walking aid, and all were able to use stairs, board public transportation, sit in a chair, and put on shoes.

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TABLE I Comparative Data Related to Thigh Pain

	Group without Thigh Pain	Group with Thigh Pain	P Value
No. of hips	58	13	Not applicable
Age*(yr)	40.6 ± 8.4	37.8 ± 4.3	0.25
Gender (no. of hips)			0.55
Male	50	12
Female	8	1
Height*(cm)	166.8 ± 6.0	171.4 ± 2.8	0.009
Weight*(kg)	62.8 ± 9.2	71.4 ± 10.5	0.004
Final Harris hip score*(points)	97.5 ± 3.1	94.4 ± 5.0	0.006
Reactive lines (no. of hips)	24	7	0.41
Body mass index*(kg/m²)	22.5 ± 2.9	24.3 ± 3.1	0.061
Limb-length discrepancy*(mm)	1.1 ± 2.3	0.0 ± 3.5	0.23
Neck length (no. of hips)			0.82
Short	18	3
Medium	37	9
Long	3	1
Stem alignment (no. of hips)			0.19
Neutral	55	11
Varus	3	2
Valgus	0	0
Undersized stem on anteroposterior radiograph (no. of hips)	22	7	0.29
Cortical hypertrophy (no. of hips)	13	1	0.23
Risk factors for osteonecrosis (no. of hips)
Alcohol	24	5	0.85
Smoking	23	3	0.26
Steroid	6	3	0.21
Trauma	7	0	0.19
Systemic lupus erythematosus	4	1	0.92
Diabetes	3	0	0.40
Gout	1	0	0.63
Idiopathic	15	5	0.36

The values are given as the mean and standard deviation.

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TABLE I Comparative Data Related to Thigh Pain

	Group without Thigh Pain	Group with Thigh Pain	P Value
No. of hips	58	13	Not applicable
Age*(yr)	40.6 ± 8.4	37.8 ± 4.3	0.25
Gender (no. of hips)			0.55
Male	50	12
Female	8	1
Height*(cm)	166.8 ± 6.0	171.4 ± 2.8	0.009
Weight*(kg)	62.8 ± 9.2	71.4 ± 10.5	0.004
Final Harris hip score*(points)	97.5 ± 3.1	94.4 ± 5.0	0.006
Reactive lines (no. of hips)	24	7	0.41
Body mass index*(kg/m²)	22.5 ± 2.9	24.3 ± 3.1	0.061
Limb-length discrepancy*(mm)	1.1 ± 2.3	0.0 ± 3.5	0.23
Neck length (no. of hips)			0.82
Short	18	3
Medium	37	9
Long	3	1
Stem alignment (no. of hips)			0.19
Neutral	55	11
Varus	3	2
Valgus	0	0
Undersized stem on anteroposterior radiograph (no. of hips)	22	7	0.29
Cortical hypertrophy (no. of hips)	13	1	0.23
Risk factors for osteonecrosis (no. of hips)
Alcohol	24	5	0.85
Smoking	23	3	0.26
Steroid	6	3	0.21
Trauma	7	0	0.19
Systemic lupus erythematosus	4	1	0.92
Diabetes	3	0	0.40
Gout	1	0	0.63
Idiopathic	15	5	0.36

The values are given as the mean and standard deviation.

Thirteen patients (fourteen hips, 20%) reported noise in the hip, which was not associated with pain or functional limitation (Table II). They described a subjective "clicking" in thirteen hips and "squeaking" in one hip. Nine patients (nine hips) experienced clicking when rising from a squatting position, and three patients (four hips) experienced it only after a prolonged period of walking. A thirty-six-year old patient with bilateral total hip arthroplasty (Case 14; Table II) reported intermittent squeaking in the left hip after a prolonged period of descending a slope but no noise in the contralateral hip. The squatting habits of the patients who reported the clicking were no different from those of the patients who did not experience clicking. With the numbers available, we could find no significant associations between noise in the hip and a variety of patient-related and prosthesis-related factors (see Appendix).

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TABLE II Demographic Details of Patients Reporting Noise in the Hip

Case	Type of Noise	Gender	Age (yr)	Weight (kg)	Height (cm)	Onset of Noise (yr after op.)	Final Harris Hip Score (points)	Underlying Conditions and Risk Factors	Limb-Length Discrepancy (mm)	Cup Size (mm)	Abduction Angle (deg)	Cup Anteversion (deg)	Neck Length
1	Clicking	Male	46	73	167	0.3	100	Alcohol abuse, smoking	-5	54	36	24	Long
2	Clicking	Male	41	62	162	4.5	100	Smoking	1	56	38	14	Medium
3	Clicking	Male	46	73	168	3	92	Alcohol abuse, smoking	-1	56	52	25	Medium
4	Clicking	Male	39	55	169	1.5	100	Corticosteroid therapy	0	54	47	26	Medium
5	Clicking	Male	39	55	169	1.5	100	Corticosteroid therapy	0	52	42	5	Medium
6	Clicking	Male	38	70	174	0.1	99	Alcohol abuse, smoking	2	58	40	26	Short
7	Clicking	Male	45	60	165	7	96	Alcohol abuse	-2	54	40	23	Medium
8	Clicking	Male	34	70	173	6	94	None	-1	56	40	20	Medium
9	Clicking	Male	31	72	170	5	96	None	3	54	40	12	Medium
10	Clicking	Male	35	83	175	6.5	92	Corticosteroid therapy	0	56	35	20	Medium
11	Clicking	Male	41	69	172	5	97	Smoking, prev. trauma	-2	60	37	11	Medium
12	Clicking	Male	47	70	170	3	98	None	2	56	38	21	Short
13	Clicking	Male	44	68	164	0.5	99	Alcohol abuse, smoking	3	50	41	8	Long
Average			40.5	67.7	169.1	3.4	97.2		0	55.1	40.5	18.1
14	Squeaking	Male	36	54	164	5	94	None	-4	58	42	26	Medium

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TABLE II Demographic Details of Patients Reporting Noise in the Hip

Case	Type of Noise	Gender	Age (yr)	Weight (kg)	Height (cm)	Onset of Noise (yr after op.)	Final Harris Hip Score (points)	Underlying Conditions and Risk Factors	Limb-Length Discrepancy (mm)	Cup Size (mm)	Abduction Angle (deg)	Cup Anteversion (deg)	Neck Length
1	Clicking	Male	46	73	167	0.3	100	Alcohol abuse, smoking	-5	54	36	24	Long
2	Clicking	Male	41	62	162	4.5	100	Smoking	1	56	38	14	Medium
3	Clicking	Male	46	73	168	3	92	Alcohol abuse, smoking	-1	56	52	25	Medium
4	Clicking	Male	39	55	169	1.5	100	Corticosteroid therapy	0	54	47	26	Medium
5	Clicking	Male	39	55	169	1.5	100	Corticosteroid therapy	0	52	42	5	Medium
6	Clicking	Male	38	70	174	0.1	99	Alcohol abuse, smoking	2	58	40	26	Short
7	Clicking	Male	45	60	165	7	96	Alcohol abuse	-2	54	40	23	Medium
8	Clicking	Male	34	70	173	6	94	None	-1	56	40	20	Medium
9	Clicking	Male	31	72	170	5	96	None	3	54	40	12	Medium
10	Clicking	Male	35	83	175	6.5	92	Corticosteroid therapy	0	56	35	20	Medium
11	Clicking	Male	41	69	172	5	97	Smoking, prev. trauma	-2	60	37	11	Medium
12	Clicking	Male	47	70	170	3	98	None	2	56	38	21	Short
13	Clicking	Male	44	68	164	0.5	99	Alcohol abuse, smoking	3	50	41	8	Long
Average			40.5	67.7	169.1	3.4	97.2		0	55.1	40.5	18.1
14	Squeaking	Male	36	54	164	5	94	None	-4	58	42	26	Medium

Radiographic Results

Sixty-six stems (93%) were in neutral alignment, and five stems were aligned in a varus position. The mean abduction angle of the acetabular component was 40.7° ± 5.5° (range, 32° to 54°), and the mean anteversion angle of the cup was 21.2° ± 6.4° (range, 5° to 29°). Eight patients (eight hips, 11%) demonstrated an abduction angle of <35°. All femoral components demonstrated osseous ingrowth. No patient showed a reactive line around the proximally coated area, but twenty-nine patients (thirty-one hips, 44%) demonstrated a reactive line of <1 mm without progression around the smooth portion of the stem after two years postoperatively. All patients showed stress shielding that was graded as second-degree or less^34,35, and cortical hypertrophy in zone 5 was observed in twelve patients (fourteen hips, 20%). Six patients (six cups, 8%) exhibited a reactive line limited to zone 1 that was <1 mm in width. No hip showed any radiographic evidence of aseptic loosening or osteolysis. There were no significant differences in the radiographic findings between the patients who reported noise and those who reported no noise (the majority of patients) (see Appendix).

Wear was not measured because it was not possible to differentiate the ceramic head from the cup on standard radiographs. The mean limb-length discrepancy was 0.9 ± 2.5 mm (range, -8 to 7 mm).

Complications

Two intraoperative linear femoral fractures were treated with cerclage wires and healed without complication. One patient (one hip) had Brooker grade-I heterotopic ossification³⁸, which did not cause any symptoms. One patient had an asymptomatic thrombosis, which was discovered in the distal portion of the superficial femoral vein on a routine postoperative sonogram. There were no fractures of the alumina heads or peripheral chip fractures of the inserts. No hip dislocated, and there were no postoperative infections. No hip was revised for any reason.

Discussion

The early experience with the use of a ceramic-on-ceramic bearing surface in total hip arthroplasty for patients with osteonecrosis of the femoral head was disappointing⁵. Over the last decade, there have been dramatic improvements in the so-called third-generation manufacturing process and in the design of ceramic components^24,41. These improvements include decreased grain size, porosity reduction, and increased strength as a result of hot isostatic pressing^18,23,24, laser etching²⁴, nondestructive proof-testing^18,20,23,24, and a metal-backed socket for acetabular fixation⁴². Nevertheless, to our knowledge, the outcome of total hip arthroplasties with third-generation ceramic bearings in patients with osteonecrosis has been reported in only one study⁶. In that prospective, randomized, multicenter study of seventy-nine arthroplasties with alumina bearings, Seyler et al. found an implant survival rate of 95.5% (95% confidence interval, 86.5% to 98.6%) at a mean of 4.2 years postoperatively. However, that study was limited because it did not include a description of the associated risk factors for osteonecrosis and the follow-up period was short.

In the present study, the absence of dislocation, ceramic head fracture, or peripheral chip fracture contrasts with the results of other studies on the use of contemporary designs with alumina bearings^6,19-21,24. Several factors may account for the low rate of these complications in our series. Surgical factors included obtaining an optimal implant position, the absence of a trochanteric osteotomy, efforts to preserve and reconstruct soft tissues, and restoration of limb length. Prosthetic factors included improved prosthetic design and ceramic properties. Finally, despite the excellent tribologic properties of ceramics, we were careful to clean the trunion prior to placement of the modular femoral head and to ensure that there was no impingement at the time of relocation of the femoral head into the acetabulum^18,20,23.

Calculating the wear of ceramics is difficult because of the inability to distinguish the ceramic head from the cup on standard radiographs and because of the very low rate of wear^21,42. Thus, we paid particular attention to the presence of endosteal scalloping at the level of the neck resection (Gruen zones 1, 7, 8, and 14) as indirect evidence of wear. Because conditions associated with ceramic wear have been reported to include a vertical cup position, impingement, and microseparation^18,20, we tried to place the acetabular component in 45° ± 10° of abduction and 15° ± 10° of anteversion.

Previous studies showed a relatively high prevalence of fracture (13% to 15%) of the BiCONTACT femoral stem because of the prosthetic geometry and the technically demanding implantation technique^19,43. However, fracture occurred in only two hips in the present study.

Mild thigh pain was reported by twelve patients (thirteen hips) and was associated with increased height and body weight. The thigh pain disappeared within two years in nine patients (ten hips), whereas three patients (three hips) had persistent mild thigh pain that did not restrict activity at the time of final follow-up. This 4% rate of thigh pain is comparable with the reported rates associated with the BiCONTACT stem (range, 3% to 14%^19,22). The noise reported by thirteen patients (fourteen hips) is a concern. The rate in our study was higher than previously reported rates^25,26. We speculate that this difference may have been due to the fact that Asian people frequently squat as well as the younger, active cohort that we studied²⁶. Toni et al.²⁵ reported that noise could be an early clinical sign of a ceramic fracture or head stripe wear and recommended clinical and radiographic evaluation for early recognition of these complications. Although impingement or instability was proposed as the main cause of this recently recognized complication, the data available in the present study are not sufficient for drawing any conclusions. At present, the mechanism(s) of the underlying noise is yet to be determined; to date, there is insufficient evidence that noise per se adversely affects longevity of total hip prostheses. Additional investigations are necessary to clarify the etiology and clinical implications.

A limitation of this study is that three hips were lost to follow-up. If each lost hip was defined as a failure, as recommended by Murray et al.⁴⁴, the worst-case survival rate as determined with Kaplan-Meier survivorship analysis would be 96.0% (95% confidence interval, 91.4% to 100%) after the minimum five-year follow-up interval. However, because the clinical performance and radiographic results associated with the three hip prostheses were excellent at the time of follow-up (before the minimum five-year interval), not all were likely to fail.

The current study had several other limitations. First, it was not a comparative study, so we can draw no conclusions regarding the outcomes of this design compared with another design in a similar group of patients. Second, it included a relatively small number of patients, which makes the statistical power of the study relatively weak. Third, the maximum body mass index of the cohort was <31 kg/m², limiting our ability to extend our conclusions to obese patients.

To our knowledge, the current study is the first midterm investigation of the outcomes of total hip arthroplasties with contemporary ceramic bearings in young patients with osteonecrosis of the femoral head. It was conducted consecutively in a homogeneous cohort at a single institution at which all of the procedures were done by the same surgeon, and confounding variables were controlled.

In summary, on the basis of the encouraging outcomes in the current study, we believe that this cementless total hip arthroplasty with contemporary alumina bearings is a promising procedure for young, active patients with osteonecrosis of the femoral head. However, longer-term follow-up is necessary to assess any effect of noise on the longevity of the prosthesis.

Appendix

Tables showing comparative data and radiographic findings as related to noise in the hip are available with the electronic versions of this article, on our web site at (go to the article citation and click on "Supplementary Material") and on our quarterly CD-ROM (call our subscription department, at 781-449-9780, to order the CD-ROM). Image Not Available

Acknowledgements

Note: The authors thank Young-Hun Sohn, MD, Sang-Won Lee, MD, and Seung-Gil Baek, MD, for their radiographic analysis. They also thank professor Im-Hee Shin at Catholic University of Daegu for her statistical analysis.

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Topics

fracture ; aluminum oxide ; ceramics ; femur head necrosis ; hip region ; hip joint ; prosthesis implantation ; hip replacement arthroplasty ; noise

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Seung-Hoon Baek, Shin-Yoon Kim; Cementless Total Hip Arthroplasty with Alumina Bearings in Patients Younger Than Fifty with Femoral Head Osteonecrosis. The Journal of Bone & Joint Surgery. 2008 Jun;90(6):1314-1320.

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