SLAP LesionBlast2NCT06772103
Biceps Tenodesis With 360 Suture Anchor Versus Self Locking Tenodesis In the Absence of Rotator Cuff Tears
A study testing self-locking biceps tenodesis and Biceps Tenodesis with 360 Suture anchor in people with SLAP Lesion, run by Clinique Générale dAnnecy at 1 site in France.
Trial summary
This is a prospective randomized controlled trial. The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double-loop 360 lasso biceps tenodesis for the treatment of pathology of the long head of the biceps or superior labrum anterior-posterior (SLAP) during… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- SLAP Lesion
- What is being tested?
- self-locking biceps tenodesis and Biceps Tenodesis with 360 Suture anchor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2025to 1 Jan 2030
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathology of the LHBT or SLAP-type lesion based on clinical symptoms
- Partial-thickness rupture or absence of full-thickness rupture of the rotator cuff of the subscapular, supraspinatus and/or infraspinatus tendons, diagnosed preoperatively on ultrasound, arthro-CT or MRI
Who cannot join
- Full-thickness tears of the rotator cuff diagnosed preoperatively on ultrasound, arthro-CT or MRI.
- Osteoarthritis of the glenohumeral joint, defined by narrowing of the glenohumeral joint space or osteophytes, using AP radiography of the affected shoulder.
- Previous surgery on the affected shoulder
- Patients presenting with motor paralysis of the shoulder
- Preoperative presence of the Popeye sign or documented LHBT rupture
- Dementia or inability to complete questionnaires and assessments in French or English.
Show all 9Show fewer
- Pregnant or breast-feeding patient
- Protected adult patient
- Patient not covered by social security.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Biceps Tenodesis With 360 Suture Anchor Versus Self-Locking Tenodesis in the Absence of Full-thickness Rotator Cuff Tears: Protocol for a Non-inferiority Randomized Controlled Trial (BLAST-2)
This is a prospective randomized controlled trial. The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double-loop 360 lasso biceps tenodesis for the treatment of pathology of the long head of the biceps or superior labrum anterior-posterior (SLAP) during shoulder arthroscopy in patients without arthroscopic rotator cuff tears. Currently, there is no consensus on the use of tenodesis versus tenotomy to treat pathology of the long head of the biceps during arthroscopic rotator cuff repair. Numerous studies have examined the clinical results of long biceps tenotomy versus long biceps tenodesis, and there is no evidence to date of superiority of either technique. However, these studies were carried out on patients with rotator cuff tears, and so it has not been possible to directly compare the two procedures. At Clinique Générale, we use a new, innovative technique called autobloc tenodesis to treat pathologies of the long head of the biceps. There are no comparative studies between autobloc tenodesis of the biceps and biceps tenodesis in patients without rotator cuff tears. Given its potential advantages, autobloc biceps tenodesis could become the new technique of choice for treating biceps longus tendon pathology, potentially reducing differences in outcomes such as Popeye deformity. The information provided by this study could potentially guide future clinical practice, helping surgeons choose the most appropriate treatment for their patients with long biceps tendon pathology.
- Conditions
- SLAP Lesion
- Being tested
- self-locking biceps tenodesis, Biceps Tenodesis with 360 Suture anchor
- Keywords
- biceps, tenodesis, imaging, tendon repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-locking biceps tenodesisProcedure or surgery
The LHB tendon is detached from its origin at the level of the superior labrum. This technique supports the self-locking mechanism of the LHB tendon in the bicipital groove by detaching the tendon from the Y-shaped superior glenoid, including the superior labrum. A radiographically visible suture will be attached to the proximal part of the LHB tendon to facilitate subsequent localization of the LHB tendon during imaging (3-0 stainless steel, ethicon).
Biceps Tenodesis with 360 Suture anchorProcedure or surgery
The LHB tendon is detached from its origin and sutured. Next, the LHB tendon is fixed in the bicipital groove using a 360-loop tenodesis technique with the Knotless FiberTak® biceps implant system. A radiographically visible suture will be attached to the proximal part of the LHB tendon to facilitate subsequent localization of the LHB tendon during imaging (3-0 stainless steel, ethicon).
| Study group | Role | What they receive |
|---|---|---|
| self-locking biceps tenodesis | Experimental | Not described Receives: Procedure: self-locking biceps tenodesis |
| 360° double-loop lasso biceps tenodesis | Active comparator | Not described Receives: Procedure: Biceps Tenodesis with 360 Suture anchor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant score
100-point scale comprising four components, including a patient-reported section (pain 15 points and activity level 20 points), for a total of 35 points. Alongside this is a doctor-reported section (shoulder strength 25 points, range of motion 40 points) for a total of 65 points.
Measured: 1 year after surgery
Secondary outcomes (7)
American Shoulder and Elbow Surgeons Score (ASES)
The ASES is a 100-point scale comprising 2 assessment dimensions: pain and activities of daily living.
Measured: 6 weeks, 3 months, 6 months, 1 year after surgery
Subjective Shoulder Value (SSV)
The SSV is a single-question assessment of the patient's perceived shoulder function expressed as a percentage of normal.
Measured: 6 weeks, 3 months, 6 months, 1 year after surgery
LHB score
The LHB score assesses symptoms and function related to long head of the biceps tendon pathology.
Measured: 6 months, 1 year after surgery
cosmetic appearance
Cosmetic appearance will be assessed by both the patient and the clinician using standardized photographs.
Measured: 6 weeks, 3 months, 6 months, 1 year after surgery
VAS pain score
Pain intensity will be assessed using a visual analogue scale (VAS) at rest, during activity, and over the bicipital groove.
Measured: 6 weeks, 3 months, 6 months, 1 year after surgery
Radiograph
Standardized radiographs will assess postoperative migration of the long head of the biceps tendon using a radio-opaque marker.
Measured: Direct post-op, 6 weeks, 3 months, 6 months after surgery
MRI or Ultra-sound
MRI or ultrasound will assess the postoperative position of the long head of the biceps tendon at final follow-up.
Measured: 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 posted13 Jan 2025
- Study start22 Jan 2025
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SLAP LesionStudies 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
- Participant
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Générale dAnnecy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772103
- Sponsor's protocol ID
- 2024-43-CGA
- Acronym
- Blast2
- Status last verified
- Jul 2026
- First submitted
- 8 Jan 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boulidam D, Shirinskiy IJ, Macken AA, Van Den Bekerom MPJ, Lafosse T, Buijze GA. Biceps tenodesis with 360 degrees suture anchor versus self-locking tenodesis in the absence of full-thickness rotator cuff tears: protocol for a non-inferiority randomised controlled trial (BLAST-2). BMJ Open. 2026 Aug 4;16(8):e120296. doi: 10.1136/bmjopen-2026-120296.
PubMed 42552012
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biceps Tenodesis With 360 Suture Anchor Versus Self-Locking Tenodesis in the Absence of Full-thickness Rotator Cuff Tears: Protocol for a Non-inferiority Randomized Controlled Trial (BLAST-2)
- ClinicalTrials.gov ID
- NCT06772103
- Acronym / sponsor ID
- Blast2 / 2024-43-CGA
- Conditions
- SLAP Lesion
- Keywords
- biceps, tenodesis, imaging, tendon repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Clinique Générale dAnnecyUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 13 Jan 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.
This is a prospective randomized controlled trial. The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double-loop 360 lasso biceps tenodesis for the treatment of pathology of the long head of the biceps or superior labrum anterior-posterior (SLAP) during shoulder arthroscopy in patients without arthroscopic rotator cuff tears. Currently, there is no consensus on the use of tenodesis versus tenotomy to treat pathology of the long head of the biceps during arthroscopic rotator cuff repair. Numerous studies have examined the clinical results of long biceps tenotomy versus long biceps tenodesis, and there is no evidence to date of superiority of either technique. However, these studies were carried out on patients with rotator cuff tears, and so it has not been possible to directly compare the two procedures. At Clinique Générale, we use a new, innovative technique called autobloc tenodesis to treat pathologies of the long head of the biceps. There are no comparative studies between autobloc tenodesis of the biceps and biceps tenodesis in patients without rotator cuff tears. Given its potential advantages, autobloc biceps tenodesis could become the new technique of choice for treating biceps longus tendon pathology, potentially reducing differences in outcomes such as Popeye deformity. The information provided by this study could potentially guide future clinical practice, helping surgeons choose the most appropriate treatment for their patients with long biceps tendon pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self-locking biceps tenodesis | Experimental | Procedure: self-locking biceps tenodesis |
| 360° double-loop lasso biceps tenodesis | Active comparator | Procedure: Biceps Tenodesis with 360 Suture anchor |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pathology of the LHBT or SLAP-type lesion based on clinical symptoms
- Partial-thickness rupture or absence of full-thickness rupture of the rotator cuff of the subscapular, supraspinatus and/or infraspinatus tendons, diagnosed preoperatively on ultrasound, arthro-CT or MRI
Key exclusion criteria (9 listed)
- Full-thickness tears of the rotator cuff diagnosed preoperatively on ultrasound, arthro-CT or MRI.
- Osteoarthritis of the glenohumeral joint, defined by narrowing of the glenohumeral joint space or osteophytes, using AP radiography of the affected shoulder.
- Previous surgery on the affected shoulder
- Patients presenting with motor paralysis of the shoulder
- Preoperative presence of the Popeye sign or documented LHBT rupture
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 |
|---|---|---|
| self-locking biceps tenodesisThe LHB tendon is detached from its origin at the level of the superior labrum. This technique supports the self-locking mechanism of the LHB tendon in the bicipital groove by detaching the tendon from the Y-shaped superior glenoid, including the superior labrum. A radiographically visible suture will be attached to the proximal part of the LHB tendon to facilitate subsequent localization of the LHB tendon during imaging (3-0 stainless steel, ethicon). | Procedure or surgery | self-locking biceps tenodesis |
| Biceps Tenodesis with 360 Suture anchorThe LHB tendon is detached from its origin and sutured. Next, the LHB tendon is fixed in the bicipital groove using a 360-loop tenodesis technique with the Knotless FiberTak® biceps implant system. A radiographically visible suture will be attached to the proximal part of the LHB tendon to facilitate subsequent localization of the LHB tendon during imaging (3-0 stainless steel, ethicon). | Procedure or surgery | 360° double-loop lasso biceps tenodesis |
Primary outcome
Constant score
Time frame: 1 year after surgery
100-point scale comprising four components, including a patient-reported section (pain 15 points and activity level 20 points), for a total of 35 points. Alongside this is a doctor-reported section (shoulder strength 25 points, range of motion 40 points) for a total of 65 points.
7 secondary outcomes
American Shoulder and Elbow Surgeons Score (ASES)
Time frame: 6 weeks, 3 months, 6 months, 1 year after surgery
Subjective Shoulder Value (SSV)
Time frame: 6 weeks, 3 months, 6 months, 1 year after surgery
LHB score
Time frame: 6 months, 1 year after surgery
cosmetic appearance
Time frame: 6 weeks, 3 months, 6 months, 1 year after surgery
VAS pain score
Time frame: 6 weeks, 3 months, 6 months, 1 year after surgery
Radiograph
Time frame: Direct post-op, 6 weeks, 3 months, 6 months after surgery
MRI or Ultra-sound
Time frame: 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 9 Jul 2026.
- Derived from this study: PubMed 42552012Boulidam D, Shirinskiy IJ, Macken AA, Van Den Bekerom MPJ, Lafosse T, Buijze GA. Biceps tenodesis with 360 degrees suture anchor versus self-locking tenodesis in the absence of full-thickness rotator cuff tears: protocol for a non-inferiority randomised controlled trial (BLAST-2). BMJ Open. 2026 Aug 4;16(8):e120296. doi: 10.1136/bmjopen-2026-120296.
- Individual participant dataSharing planned: No
Related trials for SLAP Lesion
Not yet recruitingObservational study
Reliability and Accuracy of a New Clinical Test for Biceps Lesions
Lesion of Long Head of Biceps, SLAP Lesion
Not yet recruiting
Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior ( SLAP) From Type II to Type IV
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-locking biceps tenodesis and Biceps Tenodesis with 360 Suture anchor in people with SLAP Lesion, run by Clinique Générale dAnnecy at 1 site in France.
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 2 inclusion and 9 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 9 Jul 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 France. 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 Geert Alexander Buijze, MD (+33 669962733, gabuijze@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant score (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06772103, which also lists 1 linked publication.
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 9 Jul 2026.