Humeral Resurfacing Hemiarthroplasty. Phase 2: Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- American Shoulder And Elbow Surgeons Shoulder Index (ASES)
研究概览
简要总结
The primary objective of this study is to examine quality of life outcomes in patients who have undergone a humeral surface replacement hemiarthroplasty.
详细描述
Resurfacing arthroplasty is gaining popularity for the reconstruction of advanced shoulder arthritis. New generation re-surfacing prostheses are engineered to anatomically restore a smooth articulating surface to the humeral head, while preserving bone stock, and potentially minimizing the risk for diaphyseal fracture. The results for shoulder resurfacing prostheses have largely been reported in retrospective reviews and have been very favorable. The purpose of this multi-centered, prospective study will be to determine the extent to which patient self-assessed outcomes (American Shoulder and Elbow Society (ASES) Score) following humeral resurfacing improve compared to pre-operative ASES scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Failed standard non-surgical management (analgesics, nsaids, physiotherapy, activity modification)
- •Persistent pain and disability for at least 6 months
- •Imaging demonstrates advanced humeral head cartilage loss
- •Pre-Operative
排除标准
- •Active or systemic joint infection
- •Significant muscle paralysis of shoulder girdle
- •Charcot's Arthropathy
- •Major medical illness (life expectancy <2years)
- •Unable to speak and read English/French
- •Psychiatric illness that precludes informed consent
- •Unwilling/unable to remain in study for one year
- •Intra-Operative Inclusion Criteria:
- •Advanced humeral head cartilage loss AND ONE of:
- •minimal/no glenoid cartilage loss
- •complete glenoid cartilage loss and no bony erosion
- •complete glenoid cartilage loss and concentric bony erosion with no humeral anterior/posterior subluxation
- •Intra-Operative Exclusion Criteria:
- •Eccentric glenoid erosion with biconcavity of glenoid and subluxation of humeral head
- •Inability of humeral head to support the CAP surface replacement
结局指标
主要结局
American Shoulder And Elbow Surgeons Shoulder Index (ASES)
时间窗: 24 months post-operative
次要结局
- Constant Score(24 months post-operative)
- Western Ontario Osteoarthritis of the Shoulder Index (WOOS)(24 months post-operative)
- Simple Shoulder Test (SST)(24 months post-operative)
- Radiographic Evaluation(3 months + yearly post-operative)