Pectoralis Minor Release Versus Non-release in RSA

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Tear Arthropathy; Reverse Total Shoulder Arthroplasty; Advanced Glenohumeral Osteoarthritis
• Intervention / Treatment: Procedure: Pectoralis Minor Release; Procedure: RSA

Detailed Description

Shoulder arthroplasty has been increasing at exponential rates, particularly due to the rise of reverse shoulder arthroplasty (RSA). Postoperative complications after RSA include infection, instability, hardware component loosening, acromial and scapular spine fractures, neurologic injury, and scapular notching which can all cause pain. However, despite excluding these causes, some patients can have persistent anterior shoulder pain with poor motion.

RSA prostheses work by translating the center of rotation (COR) inferiorly and medially, which increases tension on the deltoid, which is thought to increase the deltoid's mechanical moment arm and thus its ability to abduct and flex the humerus. However, excessive lengthening may be a cause of acromial and scapular spine fractures or neurologic injury. In addition, other structures are tensioned, including the conjoint tendon (short head of the biceps brachii and coracobrachialis) and pec minor (PM). It is unclear if lengthening these muscle-tendon units has functional consequences or whether it can create an intrinsic pathology. It is therefore feasible that muscle lengthening could create tendinitis, which could lead to persistent anterior shoulder pain after RSA. In addition, excessive tension or over-activity in the PM is also known to be a cause of altered scapula biomechanics.

Good scapula biomechanics after RSA are critical to preserving an impingement-free range of motion, which is important in maximizing postoperative outcomes, implant longevity, and preventing component loosening and instability. However, it is known from the non-arthroplasty population that during repetitive movements with scapular protraction, a hyperactive or spasming PM shortens and develops contracture, leading to protracted resting scapular position and altered scapular contribution to shoulder range of motion.1 This causes altered scapular kinematics, or dyskinesia, and alters scapular accommodation to shoulder motion, a well-known feature in various shoulder pathologies. This can be a major problem after RSA when scapula accommodation is critical to ROM and function.

Due to the expendability of the pectoralis minor, its release would cause minimal functional detriment in non-pathological cases, but in cases of overactivity, release could markedly improve scapula biomechanics. This can be performed open or arthroscopically, but the concomitant open release would be straight-forward at the time of the index surgery through the same incision

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Wagner, MD; Phone Number: 404-778-7249; Email: Eric.r.wagner@emory.edu
• Study Contact Backup: Name: Musab Gulzar; Phone Number: 201-344-0298; Email: mgulzar@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Clinic
      • Sub-Investigator: Michael Gottschalk, MD
      • Contact: Eric Wagner, MD; Phone Number: 404-778-7249; Email: Eric.r.wagner@emory.edu
      • Contact: Musab Gulzar; Phone Number: 201-344-0298; Email: mgulzar@emory.edu
    • Atlanta, Georgia, United States, 30329
      • Emory Healthcare Orthopaedics and Spine Center
      • Contact: Eric Wagner, MD; Phone Number: 404-778-7249; Email: Eric.r.wagner@emory.edu
      • Contact: Musab Gulzar; Phone Number: 201-344-0298; Email: mgulzar@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RSA with pectoralis minor release	Procedure: Pectoralis Minor Release; 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.; Procedure: RSA; RSA is the current Standard of Care (SOC)
Active Comparator: RSA without pectoralis minor release	Procedure: RSA; RSA is the current Standard of Care (SOC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
Number of complications	Number of complications post intervention would be measured.	1 year
Number of reoperations	Number of reoperations following intervention would be measured.	1 year
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)
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)

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Eric Wagner, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: March 2, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Range of motion; Reverse Total Shoulder Arthroplasty; Reverse Shoulder Arthroplasty; Pectoralis Minor; American Shoulder and Elbow
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Arthritis; Rupture; Shoulder Injuries; Tendon Injuries; Crystal Arthropathies; Chondrocalcinosis; Rotator Cuff Injuries; Rotator Cuff Tear Arthropathy
• Other Study ID Numbers: STUDY00007201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No