Lesser Tuberosity Osteotomy for Subscapularis Repair

NCT ID: NCT02762903

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-06-30

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Tenotomy

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

Group Type: ACTIVE_COMPARATOR

TSA with tenotomy technique

Intervention Type: PROCEDURE

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.

Shoulder prosthesis

Intervention Type: DEVICE

Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.

Osteotomy

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

Group Type: ACTIVE_COMPARATOR

TSA with lesser tuberosity osteotomy technique

Intervention Type: PROCEDURE

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.

Shoulder prosthesis

Intervention Type: DEVICE

Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.

Interventions

TSA with tenotomy technique

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.

Intervention Type: PROCEDURE

TSA with lesser tuberosity osteotomy technique

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.

Intervention Type: PROCEDURE

Shoulder prosthesis

Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William N. Levine, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

References

Levine WN, Munoz J, Hsu S, Byram IR, Bigliani LU, Ahmad CS, Kongmalai P, Shillingford JN. Subscapularis tenotomy versus lesser tuberosity osteotomy during total shoulder arthroplasty for primary osteoarthritis: a prospective, randomized controlled trial. J Shoulder Elbow Surg. 2019 Mar;28(3):407-414. doi: 10.1016/j.jse.2018.11.057.

Reference Type: RESULT

PMID: 30771825 (View on PubMed)

Other Identifiers

AAAE1446

Identifier Type: -

Identifier Source: org_study_id