- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06258278
Clinical Results of Arthroscopic-Assisted Lower Trapezius Tendon Transfer for Massive, Irreparable Rotator Cuff Tears
April 10, 2026 updated by: İnci Hazal Ayas, Gazi University
This study aimed to describe a modified technique for arthroscopic-assisted transfer of the lower trapezius tendon in a selected group of patients with irreparable rotator cuff tears and to evaluate its short-term results.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Patients scheduled for surgery will undergo evaluation one day before the surgical procedure and again at the six-month postoperative mark.
Pain intensity will be assessed using the Visual Analog Scale (VAS), while shoulder function will be evaluated using both the University of California, Los Angeles (UCLA) Shoulder Score and the Constant-Murley Shoulder Score.
Scapular dyskinesis was assessed using visual observation based on the Kibler classification.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ankara
-
Ankara, Ankara, Turkey (Türkiye), 06560
- Gazi University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patients with massive, chronic (>6 months), irreparable rotator cuff tears;
- patients with no concomitant irreparable subscapularis tears;
- patients who underwent a trial of at least 6-month period of conservative treatment with no benefit;
- patients with a stage 3 or greater degree of supraspinatus muscle fatty infiltration;
Exclusion Criteria:
- patients with glenohumeral arthritis;
- patients with adhesive capsulitis or passive joint motion restriction
- patients with neurologic deficits
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Massive Irreparable Rotator Cuff Tears
Patients scheduled for arthroscopically assisted lower trapezius transfer due to irreparable massive rotator cuff tears
|
The procedure, conducted under general anesthesia, starts with diagnostic arthroscopy followed by excision of the posterior bursa and preparation of the rotator cuff footprint.
Attention then shifts to harvesting the low trapezius tendon, accessed through a 10cm incision over the spina scapula.
The tendon is detached, dissected, and released from adhesions, ensuring not to damage its pedicle.
A fascia lata graft is harvested from the ipsilateral thigh and sutured to the low trapezius tendon in a continuous, locking manner to aid fixation on the humeral head.
A subdeltoid tunnel is formed, and the graft is shuttled into the subacromial space and fixed at the bicipital groove and tuberculum majus with knotless anchors.
The stability of fixation and mobility of the low trapezius muscle are verified, and the graft and tendon are sutured together with tension, with the arm held in 90° abduction and maximum external rotation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: one day before surgery
|
Pain intensity is assessed using the Visual Analog Scale (VAS).
Patients are presented with a 10-centimeter horizontal line labeled with 'No Pain' at one end (scored as 0) and 'Worst Pain Imaginable' at the other end (scored as 10).
Patients are instructed to mark on the line the point that represents their current level of pain.
The distance from the 'No Pain' end to the patient's mark is measured to determine the pain score, with higher scores indicating greater pain intensity.
|
one day before surgery
|
|
Shoulder ability
Time Frame: one day before surgery
|
The Constant-Murley score is used to evaluate shoulder function.
This scoring system comprises four subscales: pain (scored out of 15 points), activities of daily living (scored out of 20 points), range of motion (scored out of 40 points), and strength (scored out of 25 points), totaling a maximum score of 100 points.
Each subscale is assessed through a series of standardized maneuvers and patient-reported outcomes.
|
one day before surgery
|
|
Shoulder function
Time Frame: one day before surgery
|
The University of California, Los Angeles (UCLA) Shoulder Rating Scale is utilized to evaluate shoulder function.
This scoring system consists of a series of questions assessing pain level, function, active forward flexion, strength, and patient satisfaction.
Each category is scored on a scale ranging from 0 to 10 or 0 to 5, with higher scores indicating better function and satisfaction
|
one day before surgery
|
|
Pain intensity
Time Frame: 6, 12 and 24 months after surgery
|
Pain intensity is assessed using the Visual Analog Scale (VAS).
Patients are presented with a 10-centimeter horizontal line labeled with 'No Pain' at one end (scored as 0) and 'Worst Pain Imaginable' at the other end (scored as 10).
Patients are instructed to mark on the line the point that represents their current level of pain.
The distance from the 'No Pain' end to the patient's mark is measured to determine the pain score, with higher scores indicating greater pain intensity.
|
6, 12 and 24 months after surgery
|
|
Shoulder ability
Time Frame: 6, 12 and 24 months after surgery
|
The Constant-Murley score is used to evaluate shoulder function.
This scoring system comprises four subscales: pain (scored out of 15 points), activities of daily living (scored out of 20 points), range of motion (scored out of 40 points), and strength (scored out of 25 points), totaling a maximum score of 100 points.
Each subscale is assessed through a series of standardized maneuvers and patient-reported outcomes.
|
6, 12 and 24 months after surgery
|
|
Shoulder function
Time Frame: 6, 12 and 24 months after surgery
|
The University of California, Los Angeles (UCLA) Shoulder Rating Scale is utilized to evaluate shoulder function.
This scoring system consists of a series of questions assessing pain level, function, active forward flexion, strength, and patient satisfaction.
Each category is scored on a scale ranging from 0 to 10 or 0 to 5, with higher scores indicating better function and satisfaction
|
6, 12 and 24 months after surgery
|
|
Scapular dyskinesis (Kibler classification)
Time Frame: one day before surgery and 6, 12 and 24 months after surgery
|
Scapular dyskinesis will be assessed using visual observation based on the Kibler classification.
Patients will perform repeated active shoulder flexion and abduction movements while the examiner observes scapular motion from the posterior view.
Scapular movement patterns will be evaluated for the presence of abnormal motion, including winging or dysrhythmia.
Based on these observations, scapular motion will be classified as normal or dyskinetic according to established criteria, with the presence of dyskinesis recorded as a categorical outcome.
|
one day before surgery and 6, 12 and 24 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ulunay Kanatlı, Gazi University
- Study Chair: Furkan Aral, Gazi University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Actual)
December 30, 2025
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
February 6, 2024
First Submitted That Met QC Criteria
February 6, 2024
First Posted (Actual)
February 14, 2024
Study Record Updates
Last Update Posted (Actual)
April 15, 2026
Last Update Submitted That Met QC Criteria
April 10, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Iayas7
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Massive Irreparable Rotator Cuff Tears
-
Parc de Salut MarHospital Clinic of Barcelona; Hospital Universitario Fundación Jiménez Díaz; Hospital... and other collaboratorsActive, not recruitingShoulder Disease | Massive Rotator Cuff TearsSpain
-
Konstantopoulio-Patission General Hospital of Nea...RecruitingMassive Rotator Cuff TearsGreece
-
Fondren Orthopedic Group L.L.P.Not yet recruitingRotator Cuff Tear Arthropathy | Massive Irreparable Rotator Cuff TearUnited States
-
Ottawa Hospital Research InstituteCanadian Orthopaedic FoundationNot yet recruitingMassive Rotator Cuff TearCanada
-
Wonkwang University HospitalUnknownMassive Rotator Cuff TearsKorea, Republic of
-
Oslo University HospitalRecruitingMassive Rotator Cuff TearsNorway
-
Kasr El Aini HospitalCompleted
-
The Leeds Teaching Hospitals NHS TrustCompleted
-
Gazi UniversityEnrolling by invitationEarly Retears and Clinical Outcomes Following Surgical Repair of Massive Rotator Cuff TearsTurkey
-
Schulthess KlinikAvailablePseudoparalysis Due to Massive Rotator Cuff TearSwitzerland
Clinical Trials on Arthroscopic-assisted lower trapezius tendon transfer surgery
-
University of Maryland, BaltimoreTerminated
-
Ottawa Hospital Research InstituteCanadian Orthopaedic FoundationNot yet recruitingMassive Rotator Cuff TearCanada
-
Unity Health TorontoUniversity Health Network, Toronto; Sunnybrook Health Sciences CentreUnknownFull Thickness Rotator Cuff TearCanada
-
Indonesia UniversityCompletedAnterior Cruciate Ligament Rupture | Sports Injury
-
Beijing Jishuitan HospitalNot yet recruitingDislocation of the Acromioclavicular Joint
-
Beijing Tsinghua Chang Gung HospitalNot yet recruitingPosterior Cruciate Ligament Tear | PCL - Posterior Cruciate Ligament Rupture | PCL - Posterior Cruciate Ligament DeficiencyChina
-
Luzerner KantonsspitalSwiss Paraplegic Centre NottwilCompleted