Lesser Tuberosity Osteotomy for Subscapularis Repair

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: TSA with lesser tuberosity osteotomy technique; Procedure: TSA with tenotomy technique; Device: Shoulder prosthesis

• Registration Number: NCT02762903
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-05
• Results First Submitted: 2021-08-12
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-16
• Last Update Submitted: 2024-07-16
• Results First Posted: 2024-08-06
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients already scheduled for total shoulder arthroplasty

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Exclusion Criteria

• Unable to provide information throughout postoperative recovery and attend subsequent office visits thereafter (a minimum of one year).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osteotomy	TSA with lesser tuberosity osteotomy technique	Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique.
Tenotomy	TSA with tenotomy technique	Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique.
Tenotomy	Shoulder prosthesis	Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique.
Osteotomy	Shoulder prosthesis	Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Radiologic Evidence of Anatomic Healing	Post operative at 1 year	Tendon healing/tuberosity union based on radiographs

Secondary Outcome Measures

Name	Time	Method
Mean Visual Analogue Pain Scale (VAS)	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.
Total Intra-Operative Time	From incision time to time of complete skin closure	To be recorded in minutes, and documented by the surgical team
Total Subscapularis Repair Time (in Minutes)	From glenoid implantation to completion of tendon or osteotomy repair	To be recorded in minutes, and documented by the surgical team
Forward Elevation (FE) Strength	1 year post-operatively	Strength testing with Dynamometer in forward elevation was conducted to determine the mean in FE strength.
External Rotation (ER) Strength	1 year post-operatively	Strength testing with Dynamometer in external rotation.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States