Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06292169
Study type Interventional
Source Emory University
Contact Eric Wagner, MD
Phone 404-778-7249
Email eric.r.wagner@emory.edu
Status Not yet recruiting
Phase N/A
Start date May 2024
Completion date January 2026

See also
  Status Clinical Trial Phase
Active, not recruiting NCT06105398 - the Effect of Core Stability on Hand Functions
Completed NCT01778777 - Safety Study of Univers® Revers Shoulder Prosthesis N/A
Recruiting NCT05002335 - Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
Active, not recruiting NCT02588027 - Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder N/A
Withdrawn NCT01873651 - Longterm Outcome of the Delta III Inverse Prosthesis Phase 4
Not yet recruiting NCT04093804 - Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty N/A
Recruiting NCT04529798 - Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless
Completed NCT01954433 - Costs and Consequences of Three Common Orthopedic Procedures on the Upper Extremity
Recruiting NCT05438914 - Subscapularis Repair in Reverse Shoulder Arthroplasty N/A
Withdrawn NCT03488433 - Abduction Brace Versus Antirotation Sling for Immobilization Following Reverse Shoulder Arthroplasty and Rotator Cuff Repair N/A
Not yet recruiting NCT05355844 - Cutibacterium Acnes in Deep Tissues in Primary Spine and Shoulder Surgery N/A
Completed NCT01687894 - Vasopressin to Prevent Hypotension During Beach Chair Surgery N/A
Enrolling by invitation NCT01405781 - Functional and Radiographic Outcomes After Shoulder Surgery
Completed NCT03111147 - Impact of Humeral Component Version on Outcomes Following RTSA N/A
Active, not recruiting NCT03425500 - Massive Rotator Cuff Tear Reconstruction N/A
Active, not recruiting NCT02679352 - SMR Stemless Shoulder Arthroplasty Clinical Study N/A
Recruiting NCT05926622 - Clinical and Radiological Outcomes of Medacta Shoulder System FR
Recruiting NCT03547947 - Clinical and Radiological Outcomes of Medacta Shoulder System
Withdrawn NCT04285606 - Effect of Postop Rehab Methods on Outcomes Following Reverse Shoulder Arthroplasty N/A
Completed NCT02512536 - Does Botulinum A Toxin Help With Pain From Rotator Cuff Arthropathy? Phase 2