About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients undergoing surgery for reverse total shoulder arthroplasty
Patients willing and able to provide informed consent
Disqualifiers
Revision arthroplasty
Reverse shoulder arthroplasty for proximal humerus fractures
Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Trial design
Parallel
Treatments tested in this trial
Pectoralis Minor Release
Procedure/SurgeryThe pectoralis minor is a muscle on the anterior chest wall attaching to the coracoid process. In the group undergoing pectoralis minor release, through the same deltopectoral incision that will not be extended or different as compared to the RSA only group, the pec minor will be exposed on the medial aspect of the coracoid at the upper part of the incision. It will be cut from its insertion on the coracoid while being careful to protect any neurovascular structures.
RSA
Procedure/SurgeryRSA is the current Standard of Care (SOC)
Treatment groups
Trial outcomes
Primary outcomes
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
Other outcomes
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
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.
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%
Change in Range of motion (ROM)
ROM is calculated in terms of angles. Lower number suggests restricted motion.
Sponsors and contacts
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