Conjoint Tendon Resection During Reverse Total Shoulder Arthroplasty

Patient Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05753904
• Other study ID #: 2094589
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: February 2024
• Source: University of Missouri-Columbia
• Contact: Charles Gusho, MD
• Phone: 2622417944
• Email: umhsorthoenroll[@]umsystem.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria

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

Exclusion criteria

• Revision RTSA

• RTSA for acute proximal humerus fracture or fracture sequela

Related Conditions & MeSH terms

• Contracture
• Internal Rotation Contracture-shoulder
• Patient Satisfaction
• Shoulder Injuries

Intervention

Procedure:
• Conjoint Tendon Resection
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.

Locations

Country	Name	City	State
United States	Missouri Orthopaedic Institute	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.