Rotator Cuff Tear Arthropathy Clinical Trial
Official title:
A Randomized Control Trial to Evaluate Release Versus Non-release of Pectoralis Minor With Reverse Shoulder Arthroplasty
The goal of this clinical trial is to assess if concomitant open pectoralis minor release would improve pain and outcomes after Reverse Shoulder Arthroplasty (RSA). The main questions it aims to answer are: - whether releasing the pectoralis minor prophylactically could have better pain relief - whether releasing the pectoralis minor prophylactically could have increased Range of motion (ROM) outcomes - whether releasing the pectoralis minor prophylactically could have higher final Patient Reported Outcome Measurements (PROMs) Participants will be randomized to either undergo RSA with pectoralis minor release or RSA without pectoralis minor release.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | January 2026 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients undergoing surgery for reverse total shoulder arthroplasty - Patients willing and able to provide informed consent Exclusion Criteria: - Revision arthroplasty - Reverse shoulder arthroplasty for proximal humerus fractures - Adults unable to consent - Individuals who are not yet adults (infants, children, teenagers) - Pregnant women - Prisoners |
Country | Name | City | State |
---|---|---|---|
United States | Emory Clinic | Atlanta | Georgia |
United States | Emory Healthcare Orthopaedics and Spine Center | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Visual analog Scale (VAS) pain scores | The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Study participants will be asked to rate their current level of pain by placing a mark on the line | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit) | |
Other | American Shoulder and Elbow Score (ASES) | 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. | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit) | |
Other | Subjective Shoulder Value (SSV) | Subjective Shoulder Value is study participant's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100% | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit) | |
Other | Change in Range of motion (ROM) | ROM is calculated in terms of angles. Lower number suggests restricted motion. | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit) | |
Other | Change in Scapulohumeral Rhythm (SHR) on Digital Dynamic Radiography (DDR) | SHR is the ratio of humeral abduction over the change in scapula upward rotation during humeral abduction. This SHR will be captured on Digital Dynamic Radiography (DDR) and reported as a change in SHR before and after the interventions. | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit) | |
Other | Number of complications | Number of complications post intervention would be measured. | 1 year | |
Other | Number of reoperations | Number of reoperations following intervention would be measured. | 1 year | |
Primary | Visual analog Scale (VAS) pain scores | The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Study participants will be asked to rate their current level of pain by placing a mark on the line | Baseline, 6 months |
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