RecruitingNot Applicable

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

Greece44 participantsStarted 2025-07-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Adult patients (over 18 years old). Massive rotator cuff tear diagnosis based on shoulder MRI. - Exclusion Criteria: Advanced glenohumeral arthritis (Hamada ≥3). Deltoid dysfunction. Irrepearable subscapularis tear. Infection. Prior shoulder surgery. Shoulder stiffness. \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Constant-Murley score

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

American Shoulder and Elbow Surgeons (ASES) score

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

Visual Analog Scale (VAS) for pain

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

Active Range of Motion (ROM)

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

Muscle strength

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

Trial details

NCT IDNCT07154641

SponsorKonstantopoulio-Patission General Hospital of Nea Ionia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-05

Contact for this trial

Dimitrios V Papadopoulos, MD, PhD

+306976016874 di_papadopoulos@yahoo.gr

View on ClinicalTrials.gov More Massive Rotator Cuff Tears trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Constant-Murley score

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

American Shoulder and Elbow Surgeons (ASES) score

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

Visual Analog Scale (VAS) for pain

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

Active Range of Motion (ROM)

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

Muscle strength

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