Rotator Cuff Tears Clinical Trial
Official title:
Randomized Clinical Trial Comparing Rotator Cuff Repair (RCR) With Subacromial Balloon Spacer (SBS) Implantation
The purpose of this pilot study is to assess the feasibility of a full randomized trial design.
The feasibility objectives are: 1. Recruitment 1. To establish an estimate of the proportion of patients screened who are eligible for inclusion, and of those, the proportion who consent. 2. To establish an estimate of the proportion of eligible patients with medium/large tears versus massive tears. 2. Surgery -to confirm agreement among surgeons regarding the protocol's standardized surgical techniques of both groups. Clinical objectives for observational purposes only are as follows: 1. Patient reported and clinical outcomes. 2. Number of "failures" in each group (defined as additional surgery and/or having <12% improvement in SANE score from baseline). ;
Status | Clinical Trial | Phase | |
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Recruiting |
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Not yet recruiting |
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Completed |
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Recruiting |
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Not yet recruiting |
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