Latissimus Dorsi Tendon Transfer vs. Superior Capsular Reconstruction in Massive Rotator Cuff Tears

NCT07154641 | Recruiting

• 1 other identifier: 102/13-3-25
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the results of two surgical operations for the treatment of massive rotator cuff tears: latissimus dorsi tendon transfer (LDT) and superior capsular reconstruction (SCR). The main question it wants to answer is which of the two operations provides better functional results, as measured by two patient-reported questionaires: the American Shoulder and Elbow Surgeons (ASES) score and the Constant-Murley score. The patients will be randomly assigned to one of two groups according to the surgery they will undergo (LDT or SCR). They will be examined clinically and asked to fill the questionaires before the surgery, at 6 weeks and at 3, 6, 12 and 24 months after surgery.

Conditions

Massive Rotator Cuff Tears

Keywords

Massive rotator cuff tears; Latissimus dorsi tendon transfer; Superior capsular reconstruction; rotator cuff tears

Outcome Measures

Primary Outcomes (5)

• Constant-Murley score

  Functionality will be measured based on the Constant-Murley score. This questionaire includes 4 sections, regarding pain, activities of daily living (ADL), range of motion (ROM) and muscle strength. The questions regarding pain and ADL are filled by the patients, whereas the assessment of ROM and muscle strength require physical examination by a member of the research team. For the assessment of strength a handheld dynamometer will be used. The minimum score is 0 and the maximum 100.

  Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.

• American Shoulder and Elbow Surgeons (ASES) score

  American Shoulder and Elbow Surgeons (ASES) score, measures functionality of the shoulder. It includes 17 multiple-choice questions which are filled by the patients and is divided in two sections: one section about pain assessment and one about activities of daily living (ADL). The minimum score is 0 and the maximum 100.

  Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.

• Visual Analog Scale (VAS) for pain

  The Visual Analog Scale for pain is a scale from 0 to 10, that measures the intensity of pain and is a patient-reported score. 0 means "no pain at all" and 10 "pain as bad as it can be". The scale is included in the Pain Questionaire of the American Shoulder and Elbow Surgeons (ASES) score.

  Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.

• Active Range of Motion (ROM)

  The active Range of Motion (ROM) will be measured before and after surgery and compared between the two arms. The participants will be examined clinically by an investigator who will be blinded to the type of surgery. The active ROM in forward flexion, abduction, internal and external roation of the shoulder will be examined. For this purpose, a typical goniometer will be used. During the examination the patients should be standing and the scapula should be stabilised in the vertical plane.

  Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.

• Muscle strength

  Muscle strength will be measured using a hand dynamometer. This is included in the last section of the Constant-Murley score. Minimum score is 0 and maximum is 25. The score is calculated as 1 point per pound or 2.2 points per kilogram. The patient should hold the weight with the arm in 90° of abduction and the elbow extended for at least 3 seconds. Three consecutive measurements are performed with at least 1 minute break in between. The measurement with the best score defines the overall score. If the patients are unable to abduct the arm 90° or if they are experiencing pain, the score is 0.

  Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.

Secondary Outcomes (2)

• Treatment of Pseudoparalysis

  Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.

• Progression of Rotator Cuff Arthropathy

  Before surgery, at 6 weeks and at 3, 6, 12, and 24 months after surgery, per participant.

Study Arms (2)

Latissimus dorsi tendon transfer group

ACTIVE COMPARATOR

22 patients are expected to undergo latissimus dorsi tendon transfer for the treatment of massive rotator cuff tears

Procedure: Latissimus dorsi tendon transfer

Superior capsular reconstruction group

ACTIVE COMPARATOR

22 patients are expected to undergo superior capsular reconstruction for the treatment of massive rotator cuff tears.

Procedure: Superior capsular reconstruction

Interventions

Latissimus dorsi tendon transfer PROCEDURE

Latissimus dorsi tendon transfer is a surgical procedure that aims to restore active range of motion and stability of the shoulder in patients with massive rotator cuff tears. The tendon of the latissimus dorsi muscle is dettached from its insertion in the midbicipital groove of the humerus and reattached to the greater tubetosity. Therefore, the muscle acts as an external rotator, while the forces created pull the humeral head down and stabilize it in the glenoid.

Latissimus dorsi tendon transfer group

Superior capsular reconstruction PROCEDURE

Superior capsular reconstruction is a surgical procedure that aims to restore shoulder stability in patients with massive rotator cuff tears. The superior capsule of the shoulder joint is attached to the greater tuberosity and is therefore often torn in cases of supraspinatus or infraspinatus tears. A fascia lata autograft is used to reconstruct the torn capsule, between the greater tuberosity and the glenoid. Thus, superior migration of the humeral head is prevented, and pain and functionality are improved.

Superior capsular reconstruction group

Eligibility Criteria

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

You may qualify if:

• Adult patients (over 18 years old). Massive rotator cuff tear diagnosis based on shoulder MRI. -

You may not qualify if:

• Advanced glenohumeral arthritis (Hamada ≥3). Deltoid dysfunction. Irrepearable subscapularis tear. Infection. Prior shoulder surgery. Shoulder stiffness.

Sponsors & Collaborators

• Konstantopoulio-Patission General Hospital of Nea Ionia: lead

Study Sites (1)

Konstantopouleio-Patision General Hospital of Nea Ionia

Athens, Attica, 14233, Greece

RECRUITING

Related Publications (1)

• Ozturk BY, Ak S, Gultekin O, Baykus A, Kulduk A. Prospective, randomized evaluation of latissimus dorsi transfer and superior capsular reconstruction in massive, irreparable rotator cuff tears. J Shoulder Elbow Surg. 2021 Jul;30(7):1561-1571. doi: 10.1016/j.jse.2021.01.036. Epub 2021 Mar 4.

  PMID: 33675971 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Dimitrios V Papadopoulos, MD, PhD

  Second Department of Orthopaedics, Medical School, National and Kapodistrian University of Athens, Athens, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitrios V Papadopoulos, MD, PhD

CONTACT

+306976016874; di_papadopoulos@yahoo.gr

Athanasios Kontogiannis, MD

CONTACT

+306988278537; thanoskon163@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedics

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: September 4, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

GR (1)