Conjoint Tendon Resection During Reverse Total Shoulder Arthroplasty

NCT05753904 | Terminated Results

• 1 other identifier: 2094589
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Injuries; Patient Satisfaction; Internal Rotation Contracture-shoulder

Keywords

Reverse Total Shoulder Arthroplasty; Functional Internal Rotation; Conjoint Tendon

Outcome Measures

Primary Outcomes (1)

• Functional Internal Shoulder Rotation

  . 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

  Functional Internal Shoulder Rotation will be measured at the 6 Month FU

Study Arms (2)

Reverse Total Shoulder Arthroplasty

NO INTERVENTION

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.

Reverse Total Shoulder Arthroplasty with Conjoint Tendon Resection

EXPERIMENTAL

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

Interventions

Conjoint Tendon Resection PROCEDURE

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.

Reverse Total Shoulder Arthroplasty with Conjoint Tendon Resection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All patients undergoing primary reverse total shoulder arthroplasty (RTSA)

You may not qualify if:

• Revision RTSA
• RTSA for acute proximal humerus fracture or fracture sequela

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Missouri Orthopaedic Institute

Columbia, Missouri, 65201, United States

Location

MeSH Terms

Conditions

Shoulder Injuries; Patient Satisfaction

Condition Hierarchy (Ancestors)

Wounds and Injuries; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Vicki Jones
• Organization: University of Missouri

jonesvicki@health.missouri.edu

573-882-7583

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: March 3, 2023
• Study Start: April 5, 2023
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: October 30, 2025
• Results First Posted: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)