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Completed

NCT Number: NCT02762903

Lesser Tuberosity Osteotomy for Subscapularis Repair

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

TSA with tenotomy technique

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.

TSA with lesser tuberosity osteotomy technique

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

Device

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

Primary outcomes

  1. Number of Subjects With Radiologic Evidence of Anatomic Healing

    Time frame: Post operative at 1 year

    Tendon healing/tuberosity union based on radiographs

Secondary outcomes

  1. Mean Visual Analogue Pain Scale (VAS)

    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.

  2. Forward Elevation (FE) Strength

    Time frame: 1 year post-operatively

    Strength testing with Dynamometer in forward elevation was conducted to determine the mean in FE strength.

  3. Total Intra-Operative Time

    Time frame: From incision time to time of complete skin closure

    To be recorded in minutes, and documented by the surgical team

  4. Total Subscapularis Repair Time (in Minutes)

    Time frame: From glenoid implantation to completion of tendon or osteotomy repair

    To be recorded in minutes, and documented by the surgical team

  5. External Rotation (ER) Strength

    Time frame: 1 year post-operatively

    Strength testing with Dynamometer in external rotation.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Lesser Tuberosity Osteotomy Versus Tenotomy for Subscapularis Repair During Total Shoulder Arthroplasty

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
May 5, 2016
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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