Pectoralis Minor Release Versus Non-release in RSA

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Pectoralis Minor Release

    Procedure/Surgery

    The 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/Surgery

    RSA is the current Standard of Care (SOC)

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: RSA with pectoralis minor releaseExperimental treatment 2 interventions
Group B: RSA without pectoralis minor releaseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, 6 months

Secondary outcomes

Other outcomes

1

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

Time frame
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
2

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.

Time frame
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
3

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%

Time frame
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)
4

Change in Range of motion (ROM)

ROM is calculated in terms of angles. Lower number suggests restricted motion.

Time frame
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year (each follow-up visit)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.