Evaluation of Medial Supraspinatus Muscle Release in Treatment of Retracted Rotator Cuff Tear

NCT06648941 | Active Not Recruiting

• 2 other identifiers: Soh-Med-24-08-01MDno one
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

\- Introduction Rotator cuff tears are a prevalent cause of shoulder pain and dysfunction, particularly among individuals engaged in repetitive overhead activities or advancing in age. The supraspinatus muscle, integral to shoulder function, initiates abduction and provides essential stability to the glenohumeral joint. When the supraspinatus tendon tears and retracts, surgical intervention is often necessary to restore function and alleviate symptoms. (1) Traditional surgical approaches for retracted rotator cuff tears typically involve reattaching the tendon to the greater tuberosity of the humerus. However, severe retraction can lead to challenges during repair, including increased tension on the repair site, potentially compromising healing and increasing the risk of re-tears. • Partial Repair with or without Augmentation: In cases of moderate retraction where complete tendon mobilization is challenging, a partial repair combined with augmentation techniques (e.g., patch augmentation, autografts, allografts) may be considered to optimize tendon-to-bone healing. • Tendon Transfer: For massive irreparable tears or poor tendon quality, tendon transfer procedures (e.g., transferring the teres minor or lower trapezius tendon) may be necessary to restore function and shoulder stability. (2) To address these challenges, medial release of the supraspinatus tendon from its attachment on the medial border of the scapula has emerged as a promising technique. Medial release involves detaching the supraspinatus tendon from its scapular attachment and mobilizing it medially. This technique aims to reduce tension at the repair site, allowing for better tendon apposition and potentially improving healing outcomes. Proponents suggest that medial release enhances biomechanical strength and reduces the risk of postoperative complications such as re-tears. However, the technique's optimal application, outcomes, and comparative effectiveness against traditional repair methods remain subjects of ongoing research and debate within the orthopedic community. (3) Given the complexity and variability of retracted rotator cuff tears, a systematic evaluation of medial release is crucial to clarify its efficacy, safety, and role in surgical management. This protocol outlines a comprehensive framework for evaluating medial release of the supraspinatus tendon in the repair of retracted rotator cuff tears. The study aims to provide evidence-based insights that can guide surgical decision-making, improve patient outcomes, and advance the field of shoulder surgery. Furthermore, medial release may enhance the biomechanical integrity of the repair. By optimizing tendon positioning and tension during repair, it could improve the mechanical strength of the repair construct. This aspect is crucial for achieving durable outcomes and preventing repair failure over time..

Conditions

Rotator Cuff Tears of the Shoulder

Keywords

rotator cuff tear; supraspinatus muscle

Outcome Measures

Primary Outcomes (1)

• Improvement in pain score ( vas) score

  Improvement in pain score ( vas) score at 12 months.

  one year

Other Outcomes (2)

• Rate of re-tear

  one year

• Incidence of complications (infection, stiffness)

  one year

Study Arms (1)

Supraspinatus muscle release

OTHER

supraspinatus muscle release in retracted rotator cuff tear

Procedure: Muscle release

Interventions

Muscle release PROCEDURE

supraspinatus muscle release

Supraspinatus muscle release

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 35-65 years
• Diagnosed with retracted rotator cuff tear confirmed by MRI
• Failed conservative treatment for at least 6 months
• Informed consent provided

You may not qualify if:

• Previous fracture around shoulder on the affected side
• shoulder infection on the affected side
• Axillary nerve injury
• Previous shoulder surgery on the affected side

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Egypt sohag

Sohag, 093, Egypt

Location

Related Publications (3)

• Burkhart SS, Danaceau SM, Pearce CE Jr. Arthroscopic rotator cuff repair: Analysis of results by tear size and by repair technique-margin convergence versus direct tendon-to-bone repair. Arthroscopy. 2001 Nov-Dec;17(9):905-12. doi: 10.1053/jars.2001.26821.

  PMID: 11694920 BACKGROUND

• Gerber C, Fuchs B, Hodler J. The results of repair of massive tears of the rotator cuff. J Bone Joint Surg Am. 2000 Apr;82(4):505-15. doi: 10.2106/00004623-200004000-00006.

  PMID: 10761941 BACKGROUND

• Boileau P, Brassart N, Watkinson DJ, Carles M, Hatzidakis AM, Krishnan SG. Arthroscopic repair of full-thickness tears of the supraspinatus: does the tendon really heal? J Bone Joint Surg Am. 2005 Jun;87(6):1229-40. doi: 10.2106/JBJS.D.02035.

  PMID: 15930531 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Myotomy

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mustafa hemaid

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 18, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: one year

Locations

EG (1)