Long Head of Biceps Brachii LesionsNCT07289334
Tenotomy Versus no Tenotomy LHB in Rotator Cuff Repair
A study testing ROTATOR CUFF REPAIR in people with Long Head of Biceps Brachii Lesions and Rotator Cuff Tears, run by Consorci Sanitari de Terrassa.
Trial summary
The function of the long head of the biceps tendon (LHBT) in the glenohumeral joint generates controversy among researchers. For some, the tendon does not have a significant function in the shoulder, while others consider it acts as a depressor of the humeral head and a stabilizer of the joint. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Long Head of Biceps Brachii Lesions, Rotator Cuff Tears
- What is being tested?
- ROTATOR CUFF REPAIR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 65 years
- Partial supraspinatus tears (≥ 50% thickness)
- Complete supraspinatus tears ≤ 3 cm in the coronal plane
- Muscle atrophy less than stage 2 according to Thomazeau
- Presence of the LHBT in the bicipital groove
Who cannot join
- Patients younger than 40 or older than 65 years
- LHBT rupture
- Partial supraspinatus tears < 50% thickness
- Supraspinatus tears > 3 cm
- Tears of other rotator cuff tendons, with or without supraspinatus involvement
- Traumatic tears with surgery performed less than 3 months after injury
Show all 13Show fewer
- Muscle atrophy ≥ stage 2 Thomazeau
- Associated degenerative glenohumeral pathology (> Samilson 1)
- Previous shoulder surgeries
- Previous shoulder infections
- Associated peripheral neurological injuries
- Degenerative neurological conditions
- Patients who refused to sign informed consent
About this study
Official title: Tenotomy Versus no Tenotomy of the Long Head of the Biceps in Rotator Cuff Repair: Clinical-functional Analysis and Ultrasound Evaluation
The function of the long head of the biceps tendon (LHBT) in the glenohumeral joint generates controversy among researchers. For some, the tendon does not have a significant function in the shoulder, while others consider it acts as a depressor of the humeral head and a stabilizer of the joint. These functions may be enhanced in cases of rotator cuff injuries, where compensatory hypertrophy and/or instability of the LHBT can occur, which can also be a source of pain. One of the imaging techniques used for diagnosing these injuries is ultrasound.
Initially, G. Walch proposed tenotomy of the LHBT in massive rotator cuff tears to improve pain and, in some cases, shoulder function. Currently, many authors advocate tenotomy of the LHBT as an adjunct to rotator cuff repair to avoid postoperative pain. However, there is no evidence that this procedure improves the clinical outcomes of isolated rotator cuff repair.
Read more
Based on the pathophysiology of the LHBT associated with rotator cuff injuries and the current trend to perform tenotomies in conjunction with cuff repair, the objectives of this doctoral thesis project were:
To compare the clinical and imaging outcomes of arthroscopic rotator cuff repairs with and without LHBT tenotomy.
To analyze the position and cross-sectional area of the LHBT in the bicipital groove using ultrasound in cases with and without tenotomy.
- Being tested
- ROTATOR CUFF REPAIR
- Keywords
- long head biceps, rotator cuff tears, tenotomy, no tenotomy
- 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.
ROTATOR CUFF REPAIRProcedure or surgery
ROTATOR CUFF REPAIR
| Study group | Role | What they receive |
|---|---|---|
| NO TENOTOMY | Placebo comparator | NO TENOTOMY OF LHBT + ROTATOR CUFF REPAIR Receives: Procedure: ROTATOR CUFF REPAIR |
| TENOTOMY | Experimental | TENOTOMY OF LHBT + ROTATOR CUFF REPAIR Receives: Procedure: ROTATOR CUFF REPAIR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Murley
100-point standardized tool for assessing shoulder function, comprising four domains Pain (0-15 points) daily life activity (0-20 points) range of motion (0-40 points) strenght (0-25 points)
0 (the worst) - 100 (the best)
Measured: 24 month
Secondary outcomes (2)
ASES
The ASES score (American Shoulder and Elbow Surgeons score) is a 100-point questionnaire used to assess shoulder function and pain, with a higher score indicating better outcomes.
From 0 (worst) to 100 (best).
Measured: 24 MONTHS
cross sectional area of the LHBT
Ultrasound Imaging: Integrity of the supraspinatus tendon (SST) repair, presence of the long head of the biceps tendon (LHBT) in the bicipital groove (BG), and cross-sectional area of the LHBT at three levels of the BG (proximal, middle, and distal).
mesured in mm2
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Jan 2015
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Head of Biceps Brachii LesionsStudies 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
- Model description
- Patients were randomly assigned to two groups, TENOTOMY (n=25) and NO TENOTOMY (n=29), using a centralized random number program.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Maria Mora Guix, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289334
- Sponsor's protocol ID
- 02-14-105-018
- Status last verified
- Dec 2025
- First submitted
- 30 Sep 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenotomy Versus no Tenotomy of the Long Head of the Biceps in Rotator Cuff Repair: Clinical-functional Analysis and Ultrasound Evaluation
- ClinicalTrials.gov ID
- NCT07289334
- Acronym / sponsor ID
- 02-14-105-018
- Keywords
- long head biceps, rotator cuff tears, tenotomy, no tenotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 17 Dec 2025 (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 function of the long head of the biceps tendon (LHBT) in the glenohumeral joint generates controversy among researchers. For some, the tendon does not have a significant function in the shoulder, while others consider it acts as a depressor of the humeral head and a stabilizer of the joint. These functions may be enhanced in cases of rotator cuff injuries, where compensatory hypertrophy and/or instability of the LHBT can occur, which can also be a source of pain. One of the imaging techniques used for diagnosing these injuries is ultrasound.
Initially, G. Walch proposed tenotomy of the LHBT in massive rotator cuff tears to improve pain and, in some cases, shoulder function. Currently, many authors advocate tenotomy of the LHBT as an adjunct to rotator cuff repair to avoid postoperative pain. However, there is no evidence that this procedure improves the clinical outcomes of isolated rotator cuff repair.
Based on the pathophysiology of the LHBT associated with rotator cuff injuries and the current trend to perform tenotomies in conjunction with cuff repair, the objectives of this doctoral thesis project were:
To compare the clinical and imaging outcomes of arthroscopic rotator cuff repairs with and without LHBT tenotomy.
To analyze the position and cross-sectional area of the LHBT in the bicipital groove using ultrasound in cases with and without tenotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients were randomly assigned to two groups, TENOTOMY (n=25) and NO TENOTOMY (n=29), using a centralized random number program.
| Arm | Type | Receives |
|---|---|---|
| NO TENOTOMY | Placebo comparator | Procedure: ROTATOR CUFF REPAIRNO TENOTOMY OF LHBT + ROTATOR CUFF REPAIR |
| TENOTOMY | Experimental | Procedure: ROTATOR CUFF REPAIRTENOTOMY OF LHBT + ROTATOR CUFF REPAIR |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 40 and 65 years
- Partial supraspinatus tears (≥ 50% thickness)
- Complete supraspinatus tears ≤ 3 cm in the coronal plane
- Muscle atrophy less than stage 2 according to Thomazeau
- Presence of the LHBT in the bicipital groove
Key exclusion criteria (13 listed)
- Patients younger than 40 or older than 65 years
- LHBT rupture
- Partial supraspinatus tears < 50% thickness
- Supraspinatus tears > 3 cm
- Tears of other rotator cuff tendons, with or without supraspinatus involvement
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 |
|---|---|---|
| ROTATOR CUFF REPAIRROTATOR CUFF REPAIR | Procedure or surgery | NO TENOTOMY, TENOTOMY |
Primary outcome
Constant Murley
Time frame: 24 month
100-point standardized tool for assessing shoulder function, comprising four domains Pain (0-15 points) daily life activity (0-20 points) range of motion (0-40 points) strenght (0-25 points) 0 (the worst) - 100 (the best)
2 secondary outcomes
ASES
Time frame: 24 MONTHS
cross sectional area of the LHBT
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Long Head of Biceps Brachii Lesions
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
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
Not yet recruitingObservational study
Reliability and Accuracy of a New Clinical Test for Biceps Lesions
Lesion of Long Head of Biceps, SLAP Lesion
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.
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 ROTATOR CUFF REPAIR in people with Long Head of Biceps Brachii Lesions and Rotator Cuff Tears, run by Consorci Sanitari de Terrassa.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 17 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 24 month). 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 17 Dec 2025.