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临床试验/NCT01987973
NCT01987973已完成不适用

Arthroscopic Repair of Chronic Two-tendon Rotator Cuff Tears by Human Dermal Allograft

Ivan Wong1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2015年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
29
试验地点
1
主要终点
Western Ontario Rotator Cuff (WORC) Index

研究概览

简要总结

The investigators hypothesize that the use of an allograft adjuvant to partial repair will lead to improved shoulder outcome measure scores compared to partial repair alone in massive rotator cuff tears.

详细描述

A total of 30 patients will be enrolled in the study. Subjects will be randomized into two arms, either (1) Partial Repair/Debridement or (2) Allograft Reconstruction.

The patients will complete a structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant, Pre-operatively and Post-operatively at 6 weeks, 3, 6, 12, 24 months. The examination will consist of range of motion testing by goniometer as well as strength testing by hand dynamometer. The patient will also complete the Western Ontario Rotator Cuff Index (WORC) questionnaire.

The main benefit of this procedure is that patients who have currently irreparable massive, chronic rotator cuff tears may acquire a means for their cuff to be repaired. This may aid in improving function of the shoulder, restoring ability to complete activities of daily living, while decreasing pain and sleep disturbances. This would allow the participant to become more functional after rehabilitation. It is our belief that this study could provide new information in helping to understand this relationship, which would in turn lead to future study in this area of orthopaedic surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Large/Massive rotator cuff tear >3cm proven on MRI

排除标准

  • •Non surgical candidate, unable to consent

研究组 & 干预措施

Partial Repair / Debridement

Active Comparator

Subjects in this arm of the study will receive the intervention "Partial Rotator Cuff Repair". This is the control group.

干预措施: Partial Rotator Cuff Repair (Procedure)

Allograft Reconstruction

Experimental

Subjects in this arm of the study will receive the intervention "Partial Rotator Cuff Repair with Allograft Augmentation"

干预措施: Partial Rotator Cuff Repair with Allograft Augmentation (Procedure)

结局指标

主要结局

Western Ontario Rotator Cuff (WORC) Index

时间窗: 24 months

A patient questionnaire evaluating shoulder pain, function.

次要结局

未报告次要终点

研究者

发起方
Ivan Wong
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ivan Wong

Orthopedic Surgeon

Nova Scotia Health Authority

研究点 (1)

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