Massive Irreparable Rotator Cuff TearsNCT06258278
Clinical Results of Arthroscopic-Assisted Lower Trapezius Tendon Transfer for Massive, Irreparable Rotator Cuff Tears
A study testing Arthroscopic-assisted lower trapezius tendon transfer surgery in people with Massive Irreparable Rotator Cuff Tears, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Massive Irreparable Rotator Cuff Tears
- What is being tested?
- Arthroscopic-assisted lower trapezius tendon transfer surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- patients with glenohumeral arthritis;
- patients with adhesive capsulitis or passive joint motion restriction
- patients with neurologic deficits
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Hospital
Ankara, Ankara, 06560
About this study
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.
Read the detailed description
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.
- Conditions
- Massive Irreparable Rotator Cuff Tears
- Being tested
- Arthroscopic-assisted lower trapezius tendon transfer surgery
- Keywords
- Irreparable Rotator Cuff Tears, Tendon Transfer, Massive Rotator Cuff Tears
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic-assisted lower trapezius tendon transfer surgeryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Massive Irreparable Rotator Cuff Tears | Experimental | Patients scheduled for arthroscopically assisted lower trapezius transfer due to irreparable massive rotator cuff tears Receives: Procedure: Arthroscopic-assisted lower trapezius tendon transfer surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Oct 2023
- Primary completion30 Dec 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Massive Irreparable Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İnci Hazal Ayas, Gazi University
- Investigators
- Ulunay Kanatlı, Principal investigator, Gazi UniversityFurkan Aral, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258278
- Sponsor's protocol ID
- Iayas7
- Status last verified
- Jun 2026
- First submitted
- 6 Feb 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Results of Arthroscopic-Assisted Lower Trapezius Tendon Transfer for Massive, Irreparable Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT06258278
- Acronym / sponsor ID
- Iayas7
- Conditions
- Massive Irreparable Rotator Cuff Tears
- Keywords
- Irreparable Rotator Cuff Tears, Tendon Transfer, Massive Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Massive Irreparable Rotator Cuff Tears | Experimental | Procedure: Arthroscopic-assisted lower trapezius tendon transfer surgeryPatients scheduled for arthroscopically assisted lower trapezius transfer due to irreparable massive rotator cuff tears |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (3 listed)
- patients with glenohumeral arthritis;
- patients with adhesive capsulitis or passive joint motion restriction
- patients with neurologic deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic-assisted lower trapezius tendon transfer surgeryThe 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. | Procedure or surgery | Massive Irreparable Rotator Cuff Tears |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulunay Kanatlı principal investigator
Gazi University
Furkan Aral study chair
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic-assisted lower trapezius tendon transfer surgery in people with Massive Irreparable Rotator Cuff Tears, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: one day before surgery). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.