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NCT Number: NCT06258278

Clinical Results of Arthroscopic-Assisted Lower Trapezius Tendon Transfer for Massive, Irreparable Rotator Cuff Tears

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Massive Irreparable Rotator Cuff Tears

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University Hospital

Ankara, 06560, Turkey (Türkiye)

About this study

Patients undergoing arthroscopic-assisted lower trapezius tendon transfer for massive irreparable posterosuperior rotator cuff tears will be evaluated preoperatively and postoperatively at 6, 12, and 24 months. Pain intensity will be assessed using the Visual Analog Scale (VAS). Shoulder function will be evaluated using the Constant-Murley score, the University of California Los Angeles (UCLA) Shoulder Score, and the Subjective Shoulder Value (SSV). Active shoulder range of motion, including anterior flexion, abduction, and external rotation, will be measured. Scapular dyskinesis will be assessed by visual observation during active shoulder flexion and abduction according to the Kibler classification. Donor-site pain related to fascia lata graft harvest will also be evaluated using VAS during follow-up. Clinically meaningful outcomes, including MCID, SCB, and PASS, will be calculated based on postoperative clinical scores and patient-reported anchor questions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic-assisted lower trapezius tendon transfer surgery

Procedure

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.

Primary outcomes

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.
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.
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.
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.
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
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
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.
Subjective Shoulder Value

Time frame: One day before surgery and 6, 12, and 24 months after surgery

The Subjective Shoulder Value (SSV) is used to assess the patient's subjective perception of shoulder function. Patients are asked to rate the function of the affected shoulder as a percentage of a completely normal shoulder, with 0% representing no shoulder function and 100% representing normal shoulder function.
Active Shoulder Range of Motion

Time frame: One day before surgery and 6, 12, and 24 months after surgery

Active shoulder range of motion will be measured in degrees, including anterior flexion, abduction, and external rotation. Higher values indicate greater shoulder mobility.
Donor-Site Pain

Time frame: 1 month, 12 months, and 24 months after surgery

Donor-site pain related to fascia lata autograft harvest will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Patient-Reported Clinical Improvement and Satisfaction

Time frame: 24 months after surgery

Patient-reported clinical improvement and satisfaction will be assessed using anchor-based questions evaluating perceived functional improvement, pain improvement, and overall satisfaction after surgery. Responses will be used to calculate clinically meaningful outcome thresholds, including substantial clinical benefit and patient acceptable symptom state.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2026
First posted: Feb 14, 2024
Registry last updated: Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.