Lesser Tuberosity Osteotomy for Subscapularis Repair

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: TSA with tenotomy technique
* Procedure: TSA with lesser tuberosity osteotomy technique
* Device: Shoulder prosthesis


Participation Criteria
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Eligibility Criteria
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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).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tenotomy<br>Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique. | Procedure: TSA with tenotomy technique<br>* 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.<br>Device: Shoulder prosthesis<br>* Standard procedure: Total shoulder arthroplasty replaces both components of the ball and socket joint with a metal device.<br>|
| Active Comparator: Osteotomy<br>Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique. | Procedure: TSA with lesser tuberosity osteotomy technique<br>* 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.<br>Device: Shoulder prosthesis<br>* Standard procedure: Total shoulder arthroplasty replaces both components of the ball and socket joint with a metal device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with radiologic evidence of anatomic healing | Tendon healing/tuberosity union based on radiographs | Post operative at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual analogue pain scale | Pain indication measurement where 0 indicates no pain and 10 indicates worst possible pain | Post operative clinic visits at 3 weeks, 3 months, 6 months, and 1 year | 
| Change in dynamometer maximum exertion reading | Strength testing with Dynamometer in forward Flexion, abduction, external rotation and internal rotation using force measurement at max level. | Post operative clinic visits at 3 weeks, 3 months, 6 months, and 1 year | 
| Total Intra-Operative time | To be recorded in minutes, and documented by the surgical team | From incision time to time of complete skin closure | 
| Total Subscapularis Repair time (in minutes) | To be recorded in minutes, and documented by the surgical team | From glenoid implantation to completion of tendon or osteotomy repair | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder arthroplasty, Lesser Tuberosity Osteotomy, Subscapularis tenotomy