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

NCT06258278 | Active Not Recruiting

• 1 other identifier: Iayas7
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Massive Irreparable Rotator Cuff Tears

Keywords

Irreparable Rotator Cuff Tears; Tendon Transfer; Massive Rotator Cuff Tears

Outcome Measures

Primary Outcomes (11)

• Pain intensity

  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

• Pain intensity

  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

  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 ability

  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

  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

• Shoulder function

  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)

  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

• Subjective Shoulder Value

  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.

  One day before surgery and 6, 12, and 24 months after surgery

• Active Shoulder Range of Motion

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

  One day before surgery and 6, 12, and 24 months after surgery

• Donor-Site Pain

  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.

  1 month, 12 months, and 24 months after surgery

• Patient-Reported Clinical Improvement and Satisfaction

  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.

  24 months after surgery

Study Arms (1)

Massive Irreparable Rotator Cuff Tears

EXPERIMENTAL

Patients scheduled for arthroscopically assisted lower trapezius transfer due to irreparable massive rotator cuff tears

Procedure: Arthroscopic-assisted lower trapezius tendon transfer surgery

Interventions

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.

Massive Irreparable Rotator Cuff Tears

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• patients with glenohumeral arthritis;
• patients with adhesive capsulitis or passive joint motion restriction
• patients with neurologic deficits

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Hospital

Ankara, Ankara, 06560, Turkey (Türkiye)

Location

Study Officials

• Ulunay Kanatlı

  Gazi University

  PRINCIPAL INVESTIGATOR

• Furkan Aral

  Gazi University

  STUDY CHAIR

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: Research asistant

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: October 1, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)