A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 5
- 主要终点
- Device Survival
研究概览
简要总结
This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement.
详细描述
This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement. The PyroTITAN™ HRA Shoulder prosthesis device configuration will include humeral resurfacing CAP without cement. Patients will be selected for recruitment into the study based upon the normally accepted criteria for primary shoulder resurfacing arthroplasty.
The investigation will be conducted by up to 10 International surgeons experienced in HRA. 387 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for 10 years.
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
- •Patients selected for inclusion will present for primary shoulder surface replacement or arthroplasty with any of the following diagnoses:
- •Osteoarthritis
- •Rheumatoid / Inflammatory Arthritis
- •Post-traumatic arthritis.
- •Focal and large (Hill-Sachs) osteochondral defects.
- •Subject is able to or capable of providing consent to participate in the clinical investigation.
- •Subject agrees to comply with this protocol, including participating in required follow-up visits at the investigations site and completing study questionnaires.
- •Subject is at least 21 years of age and skeletally mature at the time of surgery.
排除标准
- •Have destruction of the proximal humerus to preclude rigid fixation of the humeral component.
- •Insufficient bone quality as determined by intra-operative evaluation.
- •Have arthritis with defective rotator cuff.
- •Have had a failed rotator cuff surgery.
- •Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
- •Have evidence of active infection.
- •Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexis injury with a flail shoulder joint).
- •Are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow-up visits prescribed by the protocol.
- •Are skeletally immature.
- •Have a known allergic reaction to pyrocarbon.
- •Have other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible.
- •Are currently participating in another clinical study.
- •Have known, active metastatic or neoplastic disease.
- •Are taking > 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
- •Are under 21 years of age or over
- •Require glenoid replacement (Glenoid Classification).
结局指标
主要结局
Device Survival
时间窗: up to 117 months
Clinical success was determined by the percentage of shoulders with device survival. Survival of the device was measured by the Kaplan-Meier survival estimate with survival defined as all the following: * Device remained implanted * Absence of device-related complications requiring surgical replacement, removal, or augmentation of components * Freedom from chronic dislocation
次要结局
- Visual Analog Scale (VAS) Pain Score(Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years)
- Radiographic Success(2 years, 3 years, 4 years, 5 years, 8 years and 10 years)
- ASES Score(Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years)
- Visual Analog Scale (VAS) Satisfaction Score(3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years)
- The Western Ontario of the Shoulder Index (WOOS) Score(Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years)
- Constant-Murley (CM) Score(Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years)
- EQ-5D-3L Quality of Life Score(Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years)
- EQ-5D-3L VAS Score(Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years)