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临床试验/NCT01086202
NCT01086202已完成不适用

Clinical Outcome Comparison Between Medial and Lateral Offset Reverse Shoulder Arthroplasty

Loma Linda University1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
Clinical Outcome Comparison Between Medical Lateral Offset Reverse Shoulder Arthroplasty

研究概览

简要总结

The purpose of this study is to prospectively evaluate two FDA approved implant designs for the Tornier Reverse Shoulder arthroplasty. The small difference in design is the amount of offset each implant has. This offset may improve clinical outcomes in the patient population. There have been no clinical comparative studies between these two designs in the literature to date. We would like to follow these patients for two years after implantation of the reverse shoulder and evaluate their radiographs, pain scores, and shoulder functional scores. this would be the first randomized prospective single blinded study of its kind.

详细描述

The combination of shoulder arthritis and rotator cuff deficiency presents quite a surgical challenge. The reverse prosthesis offers a treatment option for subset of patients as previous attempts to treat with soft tissue reconstruction or conventional arthroplasty have provided sub-optimal clinical results. Numerous reports in the literature have validated the effectiveness of the reverse design.

Patients meeting criteria must be between the ages of 50 and 95 years of age and are a candidate for a reverse shoulder arthroplasty. This is includes patients with rotator cuff tear arthroplasty, irreparable rotator cuff tears, significant proximal humerus fractures and malunions, and chronic proximal humerus dislocators. A total of 40 patients will be enrolled and randomized to either one of two groups; 20 patients will be randomized to the Tornier Reversed shoulder Arthroplasty Medial offset, and 20 will receive the Lateral offset design. Both implants are FDA approved. The patients will be followed for 24 months and will follow-up will be at 6 weeks, 3 months, 6 months, 12 months and 24 months questionnaires will be completed at each visit, x-rays will be done at pre-op, 3 month, 6 months 12 and 24 months.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient that is a candidate for reverse shoulder arthroplasty this includes:
  • rotator cuff tear arthroplasty,
  • irreparable rotator cuff tear,
  • significant proximal humerus fracture and malunions,
  • chronic proximal humerus dislocation.

排除标准

  • Any patient with previous arthroplasty on affected shoulder.
  • Patient who will need additional procedures including: bone grafting of the glenoid and muscle transfer.
  • Patients who do not want to participate or participate in follow-ups.

结局指标

主要结局

Clinical Outcome Comparison Between Medical Lateral Offset Reverse Shoulder Arthroplasty

时间窗: 36 Months

We would like to follow these patients for two years after implantation of the reverse shoulder and evaluate their radiographs, pain scores, and shoulder functional scores. this would be the first randomized prospective single blinded study of its kind.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wesley P. Phipatanakul

M.D. Asscoaite Professor

Loma Linda University

研究点 (1)

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