Clinical Trials Directory

Trials / Terminated

TerminatedNCT05753904

Conjoint Tendon Resection During Reverse Total Shoulder Arthroplasty

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
26 (actual)
Sponsor
University of Missouri-Columbia · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

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.

Detailed 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. 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREConjoint Tendon ResectionFor 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.

Timeline

Start date
2023-04-05
Primary completion
2024-05-16
Completion
2024-05-16
First posted
2023-03-03
Last updated
2025-10-30
Results posted
2025-10-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05753904. Inclusion in this directory is not an endorsement.