Hospital for Special Surgery, New York, NY.
Anderson Orthopaedic Research Institute, Alexandria, Virginia.
J Bone Joint Surg Am. 2021 Jul 21;103(14):1303-1311. doi: 10.2106/JBJS.20.01886.
The BIRMINGHAM HIP Resurfacing (BHR) system is a metal-on-metal hip implant system approved by the U.S. Food and Drug Administration in 2006. The approval required a multicenter, prospective, post-market-approval study. Our purpose is to report the current results at 10 years of follow-up.
Between October 2006 and December 2009, 280 primary BHR procedures were performed at 5 sites. Outcome measures included Kaplan-Meier survivorship, reasons for revision, radiographic component stability and osteolysis, Harris hip scores, and metal levels including cobalt and chromium. The mean age at the time of the procedure was 51.3 ± 7.1 years, 74% (206) of 280 BHRs were implanted in male patients, the mean body mass index was 27.8 ± 4.4 kg/m2, and 95% (265) of 280 hips had a primary diagnosis of osteoarthritis. The mean follow-up among all 280 hips was 9.0 ± 2.5 years. Prior to 10-year follow-up, 20 hips were revised and 5 patients representing 5 hips had died. Among the remaining 255 hips, 218 (85%) met the minimum follow-up of 10 years.
The 10-year survival free from all-cause component revision was 92.9% (95% confidence interval [CI], 89.8% to 96.1%) for all hips and 96.0% (95% CI, 93.1% to 98.9%) among male patients <65 years old at the time of the procedure. Reasons for revision included femoral loosening (n = 5), femoral neck fracture (n = 3), pseudotumor (n = 3), osteolysis (n = 2), and acetabular loosening (n = 1), as well as 6 revisions for a combination of pain, noise, or metal levels. Among unrevised hips, the median Harris hip score improved from preoperatively (59) to 1 year postoperatively (99; p < 0.001) and remained stable through 10 years postoperatively (99; p = 0.08). Radiographically, 5% (10) of 218 unrevised hips had osteolysis with no component migration. Median metal levels had increased at 1 year postoperatively (cobalt: from 0.12 ppb preoperatively to 1.5 ppb at 1 year postoperatively, p < 0.001; chromium: from 0.6 ppb preoperatively to 1.7 ppb at 1 year postoperatively, p < 0.001), then remained stable through 5 years before slightly decreasing at 10 years postoperatively (cobalt: 1.3 ppb, p < 0.001; chromium: 1.4 ppb, p < 0.001).
This prospective, multicenter, post-market-approval study demonstrated that the BHR implant system is safe and effective through 10 years of follow-up, particularly among young male patients.
Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
Birmingham Hip Resurfacing（BHR）系统是一种获得美国食品和药物管理局批准的金属对金属髋关节植入物系统，于 2006 年获得批准。批准要求进行多中心、前瞻性、上市后批准研究。我们的目的是报告 10 年随访的当前结果。
2006 年 10 月至 2009 年 12 月，在 5 个地点进行了 280 例原发性 BHR 手术。结果评估包括 Kaplan-Meier 生存率、翻修原因、影像学组件稳定性和骨溶解、Harris 髋关节评分以及金属水平，包括钴和铬。手术时的平均年龄为 51.3±7.1 岁，280 例 BHR 中有 74%（206 例）植入男性患者，平均体重指数为 27.8±4.4kg/m2，95%（265 例）的髋关节有原发性骨关节炎诊断。所有 280 例髋关节的平均随访时间为 9.0±2.5 年。在 10 年随访之前，20 例髋关节进行了翻修，5 例患者（代表 5 例髋关节）死亡。在其余 255 例髋关节中，218 例（85%）满足至少 10 年的随访要求。
所有髋关节的 10 年无全因组件翻修生存率为 92.9%（95%置信区间[CI]，89.8%至 96.1%），65 岁以下男性患者为 96.0%（95%CI，93.1%至 98.9%）。翻修的原因包括股骨松动（n=5）、股骨颈骨折（n=3）、假瘤（n=3）、骨溶解（n=2）和髋臼松动（n=1），以及 6 例因疼痛、噪音或金属水平组合而进行的翻修。在未翻修的髋关节中，Harris 髋关节评分中位数从术前（59）改善至术后 1 年（99；p<0.001），并在术后 10 年保持稳定（99；p=0.08）。影像学上，5%（10 例）未翻修的髋关节出现骨溶解，但无组件迁移。术后 1 年金属水平升高（钴：从术前的 0.12ppb 升高至术后 1 年的 1.5ppb，p<0.001；铬：从术前的 0.6ppb 升高至术后 1 年的 1.7ppb，p<0.001），然后在 5 年前保持稳定，在术后 10 年略有下降（钴：1.3ppb，p<0.001；铬：1.4ppb，p<0.001）。
这项前瞻性、多中心、上市后批准研究表明，BHR 植入物系统在 10 年的随访中是安全有效的，尤其是在年轻男性患者中。
治疗性 IV 级。有关证据水平的完整描述，请参见作者说明。
