NCT06258278|Active Not Recruiting
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Sponsor study identifier
interventional
25
1 country
1
Study Start
October 1, 2023
Actual (reported)Primary Completion
December 30, 2025
Actual (reported)Study Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2023
Actual (reported)February 6, 2024
Actual (reported)February 14, 2024
Actual (reported)December 30, 2025
Actual (reported)June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Gazi University Hospital
Ankara, Ankara, 06560, Turkey (Türkiye)
Ulunay Kanatlı
Gazi University
Furkan Aral
Gazi University
25 participants (actual enrollment reported by the registry).
First Submitted
February 6, 2024
First Posted
February 14, 2024
Study Start
October 1, 2023
Actual (reported)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
Contact the study team to confirm eligibility.
Primary Completion
December 30, 2025
Actual (reported)Study Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 12, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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