Clinical trial NCT05753904: Conjoint Tendon Resection During Reverse Total Shoulder Arthroplasty
Official title: The Impact of Conjoint Tendon Resection on Functional Internal Rotation of the Shoulder Following Reverse Shoulder Arthroplasty: A Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Injuries
Patient Satisfaction
Internal Rotation Contracture-shoulder
Keywords: Reverse Total Shoulder Arthroplasty
Functional Internal Rotation
Conjoint Tendon
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion criteria

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

Exclusion criteria

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

Primary outcomes:
measure: Change in Functional Internal Shoulder Rotation Over Time Points
timeFrame: 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 outcomes:
measure: Change in Visual Analog Scale (VAS) Pain Score Over Time Points
timeFrame: 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.
measure: Change in American Shoulder and Elbow (ASES) Score Over Time Points
timeFrame: 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.
measure: Change in Single Assessment Numeric Evaluation (SANE) Score Over Time Points
timeFrame: 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.
measure: Change in Patient Reported Outcome Information System (PROMIS) Score Over Time Points
timeFrame: 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.
measure: Change in Veterans Rand 12 Health (VR-12) Score Over Time Points
timeFrame: 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.
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Missouri Orthopaedic Institute
state: Missouri
Study officials:
References: