A Clinical and Radiological Study to Evaluate the Safety and Efficacy of the PyroTITAN Humeral Resurfacing Arthroplasty (HRA) Device in a New Cohort of Patients After Product Re-Release
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Device Survival: Kaplan-Meir Estimate
研究概览
简要总结
The study is designed as a single center, post-market, non-randomized, open-label, observational clinical study with retrospective and prospective enrollment to evaluate the 2-year post implantation survivorship of the PyroTITAN™ HRA device following the implementation of a new proof test to identify and eliminate devices with sub-standard mechanical integrity.
详细描述
The study is designed as a single center, post-market, non-randomized, open-label, observational clinical study with retrospective and prospective enrollment to evaluate the 2-year post implantation survivorship of the PyroTITAN™ HRA device following the implementation of a new proof test to identify and eliminate devices with sub-standard mechanical integrity. The results will be compared to data collected in a prior study conducted before implementing the new proof test. The PyroTITAN™ HRA Shoulder prosthesis device configuration will include humeral resurfacing CAP without cement. Patients will be selected retrospectively and prospectively for recruitment into the study based upon the normally accepted criteria for primary shoulder resurfacing arthroplasty.
137 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for up to 60 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex will be included, if they:
- •Present (prospective cohort) or presented (retrospective cohort) 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 receives (prospective cohort) the PyroTITAN HRA device after the re-release of the product or received (retrospective cohort) the PyroTITAN HRA device after the re- release of the product and is enrolled in the study prior to their two-year follow-up visit.
- •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 18 years of age and skeletally mature at the time of surgery.
排除标准
- •Patients will be excluded from participation if they:
- •Has/had destruction of the proximal humerus to preclude rigid fixation of the humeral component.
- •Has/had insufficient bone quality as determined by intra- operative evaluation.
- •Has/had arthritis with defective rotator cuff.
- •Has/had had a failed rotator cuff surgery.
- •Has/had loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
- •Has/had evidence of active infection.
- •Present/presented with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexus 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/were skeletally immature.
- •Has/had a known allergic reaction to PyroCarbon.
- •Has/had 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.
- •Has/had known, active metastatic or neoplastic disease.
- •Are/were taking > 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
- •Are/were under 21 years of age or over
- •Require/required glenoid replacement.
- •Retrospective patients cannot be enrolled if they are two year or greater out from the index surgery.
- •Women, who are pregnant or are planning to become pregnant.
结局指标
主要结局
Device Survival: Kaplan-Meir Estimate
时间窗: 2 years
Device survival was defined as the absence of device fracture at the two year time-point. Percentage of participants with survival of the device estimated using the Kaplan-Meier method.
次要结局
- Number of Participants With Device-Related Adverse Events(Post-operatively to 5-Years)
- Cumulative Device Success(2-Years and 5-Years)
- Cumulative Device Survival(2-Years and 5-Years)
- Device Functionality: American Shoulder and Elbow Surgeons (ASES) Score(Baseline, 2-Years and 5-Years)
- Device Functionality: Visual Analog Scale (VAS) - Pain(Baseline, 2-Years and 5-Years)
- Device Functionality: Visual Analog Scale (VAS) - Satisfaction(Baseline, 2-Years and 5-Years)
- Device Functionality: Western Ontario Osteoarthritis Score (WOOS)(Baseline, 2-Years and 5-Years)
- Device Functionality: QuickDASH Outcome Measure(Baseline, 2-Years and 5-Years)
- Device Functionality: Constant Murley Score (CMS)(Baseline, 2-Years and 5-Years)