Lesser Tuberosity Osteotomy for Subscapularis Repair

Columbia University

Status: Completed

Conditions: Osteoarthritis

Treatments: Procedure: TSA with lesser tuberosity osteotomy technique; Procedure: TSA with tenotomy technique; Device: Shoulder prosthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT02762903

AAAE1446

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients already scheduled for total shoulder arthroplasty

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Tenotomy

Active Comparator group

Description:

Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique.

Treatment:

Device: Shoulder prosthesis

Procedure: TSA with tenotomy technique

Osteotomy

Active Comparator group

Description:

Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique.

Treatment:

Device: Shoulder prosthesis

Procedure: TSA with lesser tuberosity osteotomy technique