Conjoint Tendon Resection During Reverse Total Shoulder Arthroplasty

Study Overview
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Brief Summary
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Reverse total shoulder arthroplasty (RTSA) can reliably restore active forward elevation, abduction, and external rotation, which are often lost in patients with massive rotator cuff tears. However, functional internal rotation (i.e., functional movements of the hand behind the body) is often unsatisfactorily restored and/or lost after RTSA. This study aims to compare the standard surgical approach for RTSA to RTSA with conjoint tendon resection with the targeted metric being postoperative functional internal rotation.

Detailed Description
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This study will be a prospective, randomized-controlled clinical trial comparing standard of care RTSA to RTSA with conjoint tendon resection in 64 patients undergoing RTSA by a single surgeon. Participants and assessors will not be blinded to intervention. The primary outcome is postoperative functional internal rotation. Secondary outcome measures include VAS, ASES, SANE, PROMIS, and VR-12 scores, as well as forward elevation and external rotation at the side, and complications at any time point. Our null hypothesis is that patients who undergo conjoint tendon resection during RTSA will have significantly increased functional internal rotation and clinically significant improved above-mentioned scores compared to non-resected tendon patients.

Official Title
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The Impact of Conjoint Tendon Resection on Functional Internal Rotation of the Shoulder Following Reverse Shoulder Arthroplasty: A Prospective, Randomized Clinical Trial

Conditions
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Shoulder Injuries, Patient Satisfaction, Internal Rotation Contracture-shoulder

Intervention / Treatment
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* Procedure: Conjoint Tendon Resection


Participation Criteria
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Eligibility Criteria
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Inclusion criteria - All patients undergoing primary reverse total shoulder arthroplasty (RTSA) Exclusion criteria Revision RTSA RTSA for acute proximal humerus fracture or fracture sequela
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will be a prospective, randomized-controlled clinical trial comparing standard of care RTSA to RTSA with conjoint tendon resection in 64 patients undergoing RTSA by a single surgeon.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Reverse Total Shoulder Arthroplasty<br>For RTSA using a deltopectoral approach, the Perform glenoid and humeral components of Tornier Stryker Reverse Shoulder system will be used for all cases. The sizes and offsets of the components will be chosen based on each patient's local anatomy which will vary among patients. The subscapularis tendon will be repaired using three transosseous nonabsorbable sutures whenever there is a reparable subscapularis tendon. After definitive implantation of the prosthesis is completed, in the 'no interventional' group, the wound will be closed in layers, and the shoulder will be immobilized in an abduction sling. | |
| Experimental: Reverse Total Shoulder Arthroplasty with Conjoint Tendon Resection<br>RTSA in the experimental group will be identical, except for that after definitive implantation of the prosthesis is completed, in the 'experimental' group, the conjoint tendon will be released completely via a transverse incision made at a level 2 cm distal to the coracoid process for the patients assigned the conjoint resection group. Electrocautery will be used for the resection, and the underlying muscular portion of the conjoint tendon will be preserved. As mentioned above, the control group will not receive this conjoint tendon resection. Similarly, in the experimental group, the wound will be closed in layers, and the shoulder will be immobilized in an abduction sling. | Procedure: Conjoint Tendon Resection<br>* For conjoint tendon resection in the experimental group, the conjoint tendon will be released completely via a transverse incision made at a level 2 cm distal to the coracoid process for the patients assigned the conjoint resection group. Electrocautery will be used for the resection, and the underlying muscular portion of the conjoint tendon will be preserved.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Internal Shoulder Rotation Over Time Points | . Functional internal rotation will be measured based on the highest anatomical level that the patient's thumb can reach: Side Ipsilateral buttock Lower lumbar Mid-lumbar Upper lumbar Thoracolumbar junction T10 and above | All participants were be surveilled per standard of care at our hospital for the targeted patient group. Patients will return for follow-up at two weeks, six weeks, three months, six months, one year, and two years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale (VAS) Pain Score Over Time Points | The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain. | All participants were be surveilled per standard of care at our hospital for the targeted patient group. Patients will return for follow-up at two weeks, six weeks, three months, six months, one year, and two years. | 
| Change in American Shoulder and Elbow (ASES) Score Over Time Points | The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. Patients can complete the questionnaire in less than five minutes (Leggin, 2006). | All participants were be surveilled per standard of care at our hospital for the targeted patient group. Patients will return for follow-up at two weeks, six weeks, three months, six months, one year, and two years. | 
| Change in Single Assessment Numeric Evaluation (SANE) Score Over Time Points | The SANE is a single-question outcome measure that asks patients to rate their function, as it pertains to the area being treated, on a scale of 0 to 100. The SANE score has excellent acceptance in some orthopedic surgery research, where it has been shown responsiveness similar to more comprehensive legacy measures. | All participants were be surveilled per standard of care at our hospital for the targeted patient group. Patients will return for follow-up at two weeks, six weeks, three months, six months, one year, and two years. | 
| Change in Patient Reported Outcome Information System (PROMIS) Score Over Time Points | PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population). | All participants were be surveilled per standard of care at our hospital for the targeted patient group. Patients will return for follow-up at two weeks, six weeks, three months, six months, one year, and two years. | 
| Change in Veterans Rand 12 Health (VR-12) Score Over Time Points | The Veterans RAND 12-Item Health Survey (VR-12) is a self-reported global health measure used to assess a patient's overall perspective of their health | All participants were be surveilled per standard of care at our hospital for the targeted patient group. Patients will return for follow-up at two weeks, six weeks, three months, six months, one year, and two years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reverse Total Shoulder Arthroplasty, Functional Internal Rotation, Conjoint Tendon