Supraspinatus TearNCT05660031
Treatment of the Biceps With Concomitant Supraspinatus Tears
A study testing LHB Tenotomy and LHB Tenodesis in people with Supraspinatus Tear, run by La Tour Hospital at 4 sites in 3 countries.
Trial summary
The long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology. Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Supraspinatus Tear
- What is being tested?
- LHB Tenotomy and LHB Tenodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Jun 2021to 1 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
- Full thickness tear of the supraspinatus tendon
- Intact subscapularis tendon
- Primary rotator cuff repair
- Age 50-80
Who cannot join
- Previous full thickness biceps tear
- Infection and neuropathic joints
- Known or suspected non-compliance, drug or alcohol abuse
- Patients incapable of judgement or under tutelage
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for MRI scan etc.
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Patient declines to participate in study
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
United States2 sites, 2 recruiting
- Recruiting
Sports Medicine and Shoulder Surgery, University of Michigan
Ann Arbor, Michigan, 48109
Asheesh Bedi, MD, asheesh.bedi@gmail.com
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Patrick Denard, MD, pjdenard@gmail.com
Canada1 site, 1 recruiting
- Recruiting
Group 23 Sports Medicine
Calgary, Alberta, T3B 6B7
Ian K Lo, MD, ikylo@ucalgary.ca
Switzerland1 site, 1 recruiting
- Recruiting
la Tour hospital
Meyrin, Canton of Geneva, 1217
Alexandre Lädermann, MD, +41 22 719 75 55, alexandre.laedermann@gmail.com
About this study
Official title: Treatment of the Biceps With Concomitant Supraspinatus Tears: A Multicenter Pragmatic Three-Arm Parallel-Group Randomized Surgical Trial
The long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology. Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of choice. Some suggest that tenotomy should be reserved for older, low-demand patients, while tenodesis should be performed in younger patients and those who engage in heavy labor. Proponents of tenotomy suggest that this is a technically easy procedure that leads to easy rehabilitation and fast return to activity with a low complication and reoperation rate. However, those who support LHB tenodesis list good preservation of elbow flexion and supination strength, improvement of functional scores, elimination of pain, and avoidance of cosmetic deformity as benefits of the procedure. Alternatively, the LHB can be maintained in the joint without tenodesis or tenotomy. In fact, it has not been clearly shown that LHB tenodesis or tenotomy leads to improved outcomes compared to leaving the biceps tendon intact.
Read the detailed description
The long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology.Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of choice. Some suggest that tenotomy should be reserved for older, low-demand patients, while tenodesis should be performed in younger patients and those who engage in heavy labor. Proponents of tenotomy suggest that this is a technically easy procedure that leads to easy rehabilitation and fast return to activity with a low complication and reoperation rate. However, those who support LHB tenodesis list good preservation of elbow flexion and supination strength, improvement of functional scores, elimination of pain, and avoidance of cosmetic deformity as benefits of the procedure. Alternatively, the LHB can be maintained in the joint without tenodesis or tenotomy. In fact, it has not been clearly shown that LHB tenodesis or tenotomy leads to improved outcomes compared to leaving the biceps tendon intact. The primary goal of this prospective multicenter randomized study is to evaluate whether LHB tenodesis grants superior post-operative functional outcomes compared to LHB tenotomy or leaving the LHB intact in patients undergoing rotator cuff repair (RCR) for an isolated full-thickness lesion of the supraspinatus. The primary goal of this prospective multicenter randomized study is to evaluate whether LHB tenodesis grants superior post-operative functional outcomes compared to LHB tenotomy or leaving the LHB intact in patients undergoing rotator cuff repair (RCR) for an isolated full-thickness lesion of the supraspinatus. The secondary goals are to determine whether there is a difference in post-operative functional outcomes between the LHB tenotomy group and the Intact LHB group, and if there is a difference in complication rates or patient satisfaction between the three groups.
- Conditions
- Supraspinatus Tear
- Being tested
- LHB Tenotomy, LHB Tenodesis
- Keywords
- Long head of the biceps, Supraspinatus tear, tenotomy, tenodesis, rotator cuff repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LHB TenotomyProcedure or surgery
Will be performed arthroscopically by cutting the LHB at its origin with arthroscopic scissors
LHB TenodesisProcedure or surgery
"ill be performed arthroscopically with a tenodesis at the top of the articular margin using an onlay technique.
| Study group | Role | What they receive |
|---|---|---|
| Leaving LHB Intact | No intervention | The long head of the biceps (LHB) will be left intact. |
| LHB tenotomy | Experimental | The long head of the biceps (LHB) will be cut at its origin. Receives: Procedure: LHB Tenotomy |
| LHB Tenodesis | Experimental | The long head of the biceps (LHB) will be cut at its origin and reattached. Receives: Procedure: LHB Tenodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASES score
American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).
Measured: At 24 post-operative months
Secondary outcomes (16)
VAS pain
Visual analog scale (VAS) pain. From 0 (best) to 10 (worst)
Measured: At 24 post-operative months
SSV
Subjective Shoulder Value (SSV). From 0 (worst) to 100 (best).
Measured: At 24 post-operative months
LHB score
Long head of the biceps (LHB) score. From 0 (worst) to 100 (best).
Measured: At 24 post-operative months
AFF
Anterior Forward Flexion. In degrees. Will be performed with a goniometer by an independent investigator
Measured: At 24 post-operative months
ER at side
External Rotation at the side. In degrees. Will be performed with a goniometer by an independent investigator
Measured: At 24 post-operative months
IR
Internal Rotation to nearest spinal level. Will be performed with a goniometer by an independent investigator
Measured: At 24 post-operative months
Complications
Any type of post-operative complication
Measured: Within 2 postoperative years
Patient satisfaction
Yes or no
Measured: At 24 post-operative months
Location of the defect (at the foot print | medial cuff failure)
Radiographic outcome evaluated using an ultrasound examination.
Measured: At 6 post-operative month
Status of the biceps tendon (intact | in continuity | defect)
Radiographic outcome evaluated using an ultrasound examination.
Measured: At 6 post-operative month
Signs of anchor displacement and location (lateral | medial row).
Radiographic outcome evaluated using an ultrasound examination.
Measured: At 6 post-operative month
Tendon thickness
Radiographic outcome evaluated using an ultrasound examination.
Measured: At 6 post-operative month
Number of patients with bursitis
Radiographic outcome evaluated using an ultrasound examination.
Measured: At 6 post-operative month
Number of patients with healing of the Supraspinatus tear according to Sugaya classification
Radiographic outcome evaluated using an ultrasound examination.
Measured: At 6 post-operative month
Number of patients with liquid in the bicipital sheath
Radiographic outcome evaluated using an ultrasound examination.
Measured: At 6 post-operative month
Number of patients with hypervascularization of the sheath
Radiographic outcome evaluated using an ultrasound examination.
Measured: At 6 post-operative month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Jun 2021
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraspinatus TearStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- La Tour Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alexandre Lädermann, La Tour Hospital
- Investigators
- Alexandre Lädermann, MD, Principal investigator, La Tour Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660031
- Sponsor's protocol ID
- 2021-00066
- Status last verified
- Apr 2025
- First submitted
- 4 Dec 2022
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of the Biceps With Concomitant Supraspinatus Tears: A Multicenter Pragmatic Three-Arm Parallel-Group Randomized Surgical Trial
- ClinicalTrials.gov ID
- NCT05660031
- Acronym / sponsor ID
- 2021-00066
- Conditions
- Supraspinatus Tear
- Keywords
- Long head of the biceps, Supraspinatus tear, tenotomy, tenodesis, rotator cuff repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- La Tour HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 21 Dec 2022 (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 long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology. Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of choice. Some suggest that tenotomy should be reserved for older, low-demand patients, while tenodesis should be performed in younger patients and those who engage in heavy labor. Proponents of tenotomy suggest that this is a technically easy procedure that leads to easy rehabilitation and fast return to activity with a low complication and reoperation rate. However, those who support LHB tenodesis list good preservation of elbow flexion and supination strength, improvement of functional scores, elimination of pain, and avoidance of cosmetic deformity as benefits of the procedure. Alternatively, the LHB can be maintained in the joint without tenodesis or tenotomy. In fact, it has not been clearly shown that LHB tenodesis or tenotomy leads to improved outcomes compared to leaving the biceps tendon intact.
Detailed description
The long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology.Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of choice. Some suggest that tenotomy should be reserved for older, low-demand patients, while tenodesis should be performed in younger patients and those who engage in heavy labor. Proponents of tenotomy suggest that this is a technically easy procedure that leads to easy rehabilitation and fast return to activity with a low complication and reoperation rate. However, those who support LHB tenodesis list good preservation of elbow flexion and supination strength, improvement of functional scores, elimination of pain, and avoidance of cosmetic deformity as benefits of the procedure. Alternatively, the LHB can be maintained in the joint without tenodesis or tenotomy. In fact, it has not been clearly shown that LHB tenodesis or tenotomy leads to improved outcomes compared to leaving the biceps tendon intact. The primary goal of this prospective multicenter randomized study is to evaluate whether LHB tenodesis grants superior post-operative functional outcomes compared to LHB tenotomy or leaving the LHB intact in patients undergoing rotator cuff repair (RCR) for an isolated full-thickness lesion of the supraspinatus. The primary goal of this prospective multicenter randomized study is to evaluate whether LHB tenodesis grants superior post-operative functional outcomes compared to LHB tenotomy or leaving the LHB intact in patients undergoing rotator cuff repair (RCR) for an isolated full-thickness lesion of the supraspinatus. The secondary goals are to determine whether there is a difference in post-operative functional outcomes between the LHB tenotomy group and the Intact LHB group, and if there is a difference in complication rates or patient satisfaction between the three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Leaving LHB Intact | No intervention | –The long head of the biceps (LHB) will be left intact. |
| LHB tenotomy | Experimental | Procedure: LHB TenotomyThe long head of the biceps (LHB) will be cut at its origin. |
| LHB Tenodesis | Experimental | Procedure: LHB TenodesisThe long head of the biceps (LHB) will be cut at its origin and reattached. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
- Full thickness tear of the supraspinatus tendon
- Intact subscapularis tendon
- Primary rotator cuff repair
- Age 50-80
Key exclusion criteria (7 listed)
- Previous full thickness biceps tear
- Infection and neuropathic joints
- Known or suspected non-compliance, drug or alcohol abuse
- Patients incapable of judgement or under tutelage
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for MRI scan etc.
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 |
|---|---|---|
| LHB TenotomyWill be performed arthroscopically by cutting the LHB at its origin with arthroscopic scissors | Procedure or surgery | LHB tenotomy |
| LHB Tenodesis"ill be performed arthroscopically with a tenodesis at the top of the articular margin using an onlay technique. | Procedure or surgery | LHB Tenodesis |
Primary outcome
ASES score
Time frame: At 24 post-operative months
American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).
16 secondary outcomes
VAS pain
Time frame: At 24 post-operative months
SSV
Time frame: At 24 post-operative months
LHB score
Time frame: At 24 post-operative months
AFF
Time frame: At 24 post-operative months
ER at side
Time frame: At 24 post-operative months
IR
Time frame: At 24 post-operative months
Complications
Time frame: Within 2 postoperative years
Patient satisfaction
Time frame: At 24 post-operative months
Location of the defect (at the foot print | medial cuff failure)
Time frame: At 6 post-operative month
Status of the biceps tendon (intact | in continuity | defect)
Time frame: At 6 post-operative month
Signs of anchor displacement and location (lateral | medial row).
Time frame: At 6 post-operative month
Tendon thickness
Time frame: At 6 post-operative month
Number of patients with bursitis
Time frame: At 6 post-operative month
Number of patients with healing of the Supraspinatus tear according to Sugaya classification
Time frame: At 6 post-operative month
Number of patients with liquid in the bicipital sheath
Time frame: At 6 post-operative month
Number of patients with hypervascularization of the sheath
Time frame: At 6 post-operative month
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 25 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Alexandre Lädermann, MD principal investigator
La Tour Hospital
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LHB Tenotomy and LHB Tenodesis in people with Supraspinatus Tear, run by La Tour Hospital at 4 sites in 3 countries.
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 7 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: looking for participants now, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada, Switzerland. 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?
Contact Alexandre Lädermann, MD (+41 22 71 975 55, alexandre.laedermann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASES score (time frame: At 24 post-operative months). 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 25 Apr 2025.