Rotator Cuff Tear Surgical RepairNCT07657689
Clinical Trial to Compare Clinical and Functional Results of the Augmentation of Supraspinatus Tears With the Long Head of the Biceps Brachii Tendon
A study testing Augmented supraspinatus repair and Convencional Supraspinatus tear repair in people with Rotator Cuff Tear Surgical Repair, run by HOSPITAL FRATERNIDAD MUPRESPA HABANA.
Trial summary
The goal of this clinical trial is to reduce the risk for re-tear in rotator cuff surgeries and improve clinical results in a working age population. The main questions it aims to answer are: If we can improve surgical results using the long head of the biceps tendon as a graft. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tear Surgical Repair
- What is being tested?
- Augmented supraspinatus repair and Convencional Supraspinatus tear repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2028
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active workers.
- A supraspinatus tear diagnosed in MRI.
- Modified Rohi equal or over 5 points.
- Failed conservative treatment (at least 3 months of phisiotherapy) or surgical indication secondary to acute traumatic tear with severe functional limitation.
- Age between 18 and 65.
- Long head of the biceps tendon pathology.
- Able to understand and sign the Informed Consent Form.
Who cannot join
- Tear of the subscapularis or infraspinatus tendon.
- Supraspinatus tears <1cm.
- Lack of long head of the biceps tendon.
- Rotator Cuff Arthropathy (Hamada >3).
- Glenohumeral osteoarthritis.
About this study
Official title: Use of Long Head of bíceps Brachii Tendon as an Augmentation for Supraspinatus Tears: a Comparative Clinical Trial.
The goal of this clinical trial is to reduce the risk for re-tear in rotator cuff surgeries and improve clinical results in a working age population. The main questions it aims to answer are:
If we can improve surgical results using the long head of the biceps tendon as a graft.
Read more
If we can reduce the risk of re-tear using the long head of the biceps tendon as a graft.
Researchers will compare participants with rotator cuff tears with two different surgical techniques to see if their clinical results improve using the long head of the biceps tendon as a graft compared with not using a graft.
Participants will be asked to get enrolled in the study not knowing in which group they will be assigned to by signing a Informed Consent Form and both groups would have the same follow up conditions and treatment.
- Conditions
- Rotator Cuff Tear Surgical Repair
- Being tested
- Augmented supraspinatus repair, Convencional Supraspinatus tear repair
- Keywords
- Rotator cuff tear, Augmentation, Long head of the biceps, Graft, Supraspinatus tear, Rotator cuff disease, Rotator cuff surgical treatment, Compressed long head of the biceps, Constant Murley Score, Ases Score
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented supraspinatus repairProcedure or surgery
After conventional arthroscopic repair of the supraspinsatus with a double row technique, an autologous graft obtained from the long head of the biceps will be used as a Graf to improve biological properties of the supraspinatus tear; aiming to reduce re-tears and to improve Clinical results.
Convencional Supraspinatus tear repairProcedure or surgery
A double row technique will be performed arthroscopically.
| Study group | Role | What they receive |
|---|---|---|
| Rotator Cuff Tear Augmented with Long head of the Biceps Tendon | Experimental | After the supraspinsatus tendon repair, a piece of the tenotomized long head of the biceps tendon will be obtained and it will be prepared using a device to obtain a plain rectangular shaped graft that will be used to augment the supraspinatus. Receives: Procedure: Augmented supraspinatus repair |
| Rotator Cuff Tear Without Augmentation | Active comparator | After the supraspinatus repair, a piece of the tenotomized long head of the biceps will be obtained but not used as a graft. Receives: Procedure: Convencional Supraspinatus tear repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Murley Score
Shoulder specific clinical Score
Measured: From enrollment to the end of follow up at 1 year after surgery
Secondary outcomes (6)
ASES score
American Shoulder and Elbow Score
Measured: From enrollment to 1 year after surgery
VAS
Pain scale
Measured: From enrollment to 1 year after surgery
Range of Motion
Motion
Measured: From enrollment to 1 year after surgery
Strenght in abduction
Measured: From enrollment to 1 year after surgery
Re-tear rate
Measured: From enrollment to 1 year after surgery
Satisfaction index
PASS score
Measured: From enrollment to 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tear Surgical RepairStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HOSPITAL FRATERNIDAD MUPRESPA HABANA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657689
- Sponsor's protocol ID
- 23/654-E_Tesis
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Long Head of bíceps Brachii Tendon as an Augmentation for Supraspinatus Tears: a Comparative Clinical Trial.
- ClinicalTrials.gov ID
- NCT07657689
- Acronym / sponsor ID
- 23/654-E_Tesis
- Conditions
- Rotator Cuff Tear Surgical Repair
- Keywords
- Rotator cuff tear, Augmentation, Long head of the biceps, Graft, Supraspinatus tear, Rotator cuff disease, Rotator cuff surgical treatment, Compressed long head of the biceps
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- HOSPITAL FRATERNIDAD MUPRESPA HABANAUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 18 Jun 2026 (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.
The goal of this clinical trial is to reduce the risk for re-tear in rotator cuff surgeries and improve clinical results in a working age population. The main questions it aims to answer are:
If we can improve surgical results using the long head of the biceps tendon as a graft.
If we can reduce the risk of re-tear using the long head of the biceps tendon as a graft.
Researchers will compare participants with rotator cuff tears with two different surgical techniques to see if their clinical results improve using the long head of the biceps tendon as a graft compared with not using a graft.
Participants will be asked to get enrolled in the study not knowing in which group they will be assigned to by signing a Informed Consent Form and both groups would have the same follow up conditions and treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotator Cuff Tear Augmented with Long head of the Biceps Tendon | Experimental | Procedure: Augmented supraspinatus repairAfter the supraspinsatus tendon repair, a piece of the tenotomized long head of the biceps tendon will be obtained and it will be prepared using a device to obtain a plain rectangular shaped graft that will be used to augment the supraspinatus. |
| Rotator Cuff Tear Without Augmentation | Active comparator | Procedure: Convencional Supraspinatus tear repairAfter the supraspinatus repair, a piece of the tenotomized long head of the biceps will be obtained but not used as a graft. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Active workers.
- A supraspinatus tear diagnosed in MRI.
- Modified Rohi equal or over 5 points.
- Failed conservative treatment (at least 3 months of phisiotherapy) or surgical indication secondary to acute traumatic tear with severe functional limitation.
- Age between 18 and 65.
Key exclusion criteria (5 listed)
- Tear of the subscapularis or infraspinatus tendon.
- Supraspinatus tears <1cm.
- Lack of long head of the biceps tendon.
- Rotator Cuff Arthropathy (Hamada >3).
- Glenohumeral osteoarthritis.
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 |
|---|---|---|
| Augmented supraspinatus repairAfter conventional arthroscopic repair of the supraspinsatus with a double row technique, an autologous graft obtained from the long head of the biceps will be used as a Graf to improve biological properties of the supraspinatus tear; aiming to reduce re-tears and to improve Clinical results. | Procedure or surgery | Rotator Cuff Tear Augmented with Long head of the Biceps Tendon |
| Convencional Supraspinatus tear repairA double row technique will be performed arthroscopically. | Procedure or surgery | Rotator Cuff Tear Without Augmentation |
Primary outcome
Constant Murley Score
Time frame: From enrollment to the end of follow up at 1 year after surgery
Shoulder specific clinical Score
6 secondary outcomes
ASES score
Time frame: From enrollment to 1 year after surgery
VAS
Time frame: From enrollment to 1 year after surgery
Range of Motion
Time frame: From enrollment to 1 year after surgery
Strenght in abduction
Time frame: From enrollment to 1 year after surgery
Re-tear rate
Time frame: From enrollment to 1 year after surgery
Satisfaction index
Time frame: From enrollment to 1 year after surgery
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 18 Jun 2026.
Related trials for Rotator Cuff Tear Surgical Repair
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Active, not recruiting
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
Rotator Cuff Tear Arthropathy, Repair of a Cuff Tear
Recruiting
Arthroscopic Rotator Cuff Repair With Long Head of Biceps Transposition and Acellular Dermal Matrix Augmentation for Large to Massive Incompletely Repairable Rotator Cuff Tears
Rotator Cuff Tears, Rotator Cuff Injuries
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented supraspinatus repair and Convencional Supraspinatus tear repair in people with Rotator Cuff Tear Surgical Repair, run by HOSPITAL FRATERNIDAD MUPRESPA HABANA.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Constant Murley Score (time frame: From enrollment to the end of follow up at 1 year after surgery). 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 18 Jun 2026.