NCT00611585已完成不适用
Birmingham Hip Resurfacing System (BHR) Post Approval Study: A Prospective, Multi-Centered Study of the Birmingham Hip Resurfacing System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 329
- 试验地点
- 11
- 主要终点
- Effectiveness evaluation based on incidence of revision, radiographic review and Harris Hip Score
研究概览
简要总结
The purpose of this study is to meet a PMA condition of approval of the BHR System. The study will evaluate the long term safety and effectiveness of the BHR system in patients with non-inflammatory and inflammatory arthritis.
详细描述
This is a post-approval, prospective, non-randomized, longitudinal, unmasked, multi-center, clinical trial designed to evaluate the longer-term safety and effectiveness of the BHR system. The data collected will permit clinical evaluation for the device performance in improving hip pain, function and range of motion through ten years. The study will permit radiographic evaluation of proper component fixation and alignment maintenance through 10 years post-operative. The incidence of revision is an especially important measure in this study. Data collected will allow analysis of the implant survivorship.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. Males or females, at least 21 years of age, inclusive, and skeletally mature.
- •B. The BHR System is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component. The BHR System is intended for use in patients requiring primary hip resurfacing arthroplasty due to:
- •non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH, or
- •inflammatory arthritis such as rheumatoid arthritis.
- •The BHR System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision.
- •C. The subject or his/her legal guardian was willing to consent to participate in the study by signing and dating the approved consent form;
- •D. The subject was available for clinical follow-up through at least ten years postoperative;
- •E. The patient met none of the
排除标准
- •Exclusion Criteria:
- •A. Subjects with infection or sepsis,
- •B. Subjects with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery,
- •C. Female subjects of child-bearing age due to unknown effect on the fetus of medal ion release.
- •D. Subjects with bone stock inadequate to support the device including:
- •Subjects with severe osteopenia should not receive a BHR procedure. Patients with a family history of severe osteoporosis or sever osteopenia.
- •Subjects with osteonecrosis or avascular necrosis (AVN) with >50% involvement of the femoral head (regardless of FICAT Grade) should not receive a BHR.
- •Note: In cases of questionable bone stock, a DEXA scan may be necessary to assess inadequate bone stock.
- •E. Subjects with known moderate to severe renal insufficiency. Subjects on medications (such as high-dose or chronic aminoglycoside treatment) or with co-morbidities (such as diabetes) that increase the risk of future, significant renal impairment should be advised of the possibility of increase in system medal ion concentration. Preoperative and postoperative monitoring of renal function 9such creatinine, GFR, BUN) at 6wk/3month, 6 month (optional visit), 1-, 2-, 3-, 4,-, 5-, and 10-year time points was necessary.
- •F. Patients who were immunosuppressed with disease such as AIDS or persons receiving high dose of corticosteroids.
- •G. Patients with psychological or neurological conditions which would pre-empt their ability or unwillingness to participate in the study.
- •H. Patients who were severely overweight.
研究组 & 干预措施
Hip Resurfacing
Birmingham Hip Resurfacing
干预措施: Birmingham Hip Resurfacing (Device)
结局指标
主要结局
Effectiveness evaluation based on incidence of revision, radiographic review and Harris Hip Score
时间窗: 3 months, 1-10 years
Proportion of Participants with Revision by 10 Years
时间窗: 10 years
Proportion of participants with revision by 10 years. A revision was defined as removal with or without replacement of the components (device revision may have been partial or total).
次要结局
- Adverse events(post op through 10 years)
- Harris Hip Score (HHS): Overall Score(Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years)
- Harris Hip Score (HHS): Pain Score(Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years)
- Harris Hip Score (HHS): Function Score(Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years)
- Harris Hip Score (HHS): Absence of Deformity Score(Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years)
- Harris Hip Score (HHS): Range of Motion Score(Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years)
- Radiographic Assessment: Any Radiographic Findings(Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years)
- Radiographic Assessment: Radiographic Findings for Acetabular Radiolucent Lines(Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years)
- Radiographic Assessment: Radiographic Findings for Acetabular Migration(Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years)
- Radiographic Assessment: Radiographic Findings for Acetabular Osteolysis Lines(Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years)
- Radiographic Assessment: Radiographic Findings for Acetabular Stress Shielding(Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years)
- Radiographic Assessment: Radiographic Findings for Femoral Radiolucent Lines(Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years)
- Radiographic Assessment: Radiographic Findings for Femoral Migration(Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years)
- Radiographic Assessment: Radiographic Findings for Femoral Osteolysis Lines(Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years)
- Radiographic Assessment: Radiographic Findings for Femoral Stress Shielding(Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years)
- Radiographic Assessment: Heterotopic Ossification(3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years)
- Cumulative Number of Revisions(3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years)
研究者
研究点 (11)
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