Columbia University Medical Center
New York, 10032, United States
NCT Number: NCT02762903
The primary objective of this study is to assess the clinical effectiveness of two different techniques used for subscapularis tendon repair during total shoulder replacement. The investigators hypothesize that participants who receive a newer repair technique called a lesser tuberosity osteotomy will have lower rates of postoperative subscapularis muscle dysfunction and rupture as compared to those who receive the traditional tenotomy repair.
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Interventional
Not applicable
New York, 10032, United States
The subscapularis tendon is mobilized during total shoulder arthroplasty in order to gain anterior access to the glenohumeral joint. Postoperative subscapularis dysfunction is being recognized more frequently and has been reported in >65% of patients following shoulder arthroplasty with a soft-tissue repair. Subscapularis dysfunction has been associated with poor functional outcomes including tendon rupture and anterior instability, a major indication for revision surgery. Recent studies suggest that a standard subscapularis tenotomy with primary tendon repair may lead to failure of the repair and decreased functional outcomes as compared to a more novel lesser tuberosity osteotomy technique. The investigators study aims to validate the results of the current literature in a prospective randomized controlled trial, which to their knowledge has not been reported on this topic.Investigators will compare clinical outcomes following these two techniques during total shoulder arthroplasty. Participants undergoing total shoulder replacement will be randomized to receive either a lesser tuberosity osteotomy or tenotomy with primary subscapularis tendon repair. All other procedures conducted in this study are considered standard of care except for ultrasounds, which are conducted for research purposes in the subscapularis tenotomy group. Postoperative outcomes will be monitored objectively and subjectively at routine postoperative office visits using physical exam, imaging (X-rays and ultrasounds), and questionnaires. If the hypothesis is proven to be true, the investigators will establish gold-standard evidence for the use of the newer osteotomy technique to improve patient satisfaction and mobility following shoulder arthroplasty.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard procedure: Utilization of tenotomy for mobilization of subscapularis during total shoulder arthroplasty (TSA). The subscapularis tendon is incised close to its attachment on the humerus. The Tendon is repaired with sutures.
Standard procedure: Utilization of the osteotomy to mobilize the subscapularis during TSA. A small fleck of bone is removed from humerus, the subscapularis tendon is still attached. The fleck of bone is reattached with sutures.
Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.
Time frame: Post operative at 1 year
Tendon healing/tuberosity union based on radiographs
Time frame: 1 year post-operatively
Pain indication measurement where 0 indicates no pain and 10 indicates worst possible pain. Mean score is reported without a range or standard deviation.
Time frame: 1 year post-operatively
Strength testing with Dynamometer in forward elevation was conducted to determine the mean in FE strength.
Time frame: From incision time to time of complete skin closure
To be recorded in minutes, and documented by the surgical team
Time frame: From glenoid implantation to completion of tendon or osteotomy repair
To be recorded in minutes, and documented by the surgical team
Time frame: 1 year post-operatively
Strength testing with Dynamometer in external rotation.
Columbia University
Other
Lesser Tuberosity Osteotomy Versus Tenotomy for Subscapularis Repair During Total Shoulder Arthroplasty
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