Rotator Cuff InjuryBLAST 1NCT06774820
Biceps Lasso Loop and Self- Locking Tenodesis Alongside Repair of Rotator Cuff Tears: Randomised Controlled Trial Study Protocol (BLAST 1)
A study testing self-blocking tenodesis and arthroscopic tenodesis in people with Rotator Cuff Injury, run by Clinique Générale dAnnecy at 1 site in France.
Trial summary
The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double 360 lasso loop biceps tenodesis for the treatment of long chief of biceps or superior labrum anterior-posterior (SLAP) tendon pathology during shoulder arthroscopy in patients undergoing arthroscopic… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Rotator Cuff Injury
- What is being tested?
- self-blocking tenodesis and arthroscopic tenodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2025to 15 Jan 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rotator cuff tear: confirmed preoperative diagnosis of a non- traumatic, full- thickness tear of the supraspinatus and/or infraspinatus and/or subscapularis tendon, as evidenced by ultrasound, arthro- CT or MRI.
- Language proficiency: sufficient to allow for communication during the informed consent process and for the completion of the study questionnaires.
Who cannot join
- Tear type: partial thickness rotator cuff tears are excluded.
- Tear severity: individuals with massive or irreparable rotator cuff tears are excluded.
- Fatty degeneration: presence of rotator cuff muscle fatty degeneration classified as Grade 4 according to the Goutallier system will result in exclusion.
- Glenohumeral osteoarthritis: patients exhibiting glenohumeral osteoarthritis, defined radiographically by the presence of joint space narrowing or osteophytes on anteroposterior (radiographs of the affected shoulder) will be excluded.
- Prior shoulder surgery: history of previous surgical intervention on the affected shoulder will result in exclusion.
- Popeye sign: preoperative presence of the Popeye sign will result in exclusion.
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- Cognitive impairment: pre- existing dementia or any condition that impairs the ability to understand study procedures and complete questionnaires and assessments is an exclusion criterion.
- Pregnant, parturient or breast-feeding patients.
- Persons under legal protection (curatorship, guardianship, safeguard of justice).
- Persons deprived of their liberty by judicial or administrative measure
- Persons under psychiatric care
- Persons not affiliated to a social security scheme
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
The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double 360 lasso loop biceps tenodesis for the treatment of long chief of biceps or superior labrum anterior-posterior (SLAP) tendon pathology during shoulder arthroscopy in patients undergoing arthroscopic rotator cuff repair. 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. 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. Given its potential advantages, self-locking biceps tenodesis could emerge as 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 to choose the most appropriate treatment for their patients suffering from long biceps tendon pathology.
- Conditions
- Rotator Cuff Injury
- Being tested
- self-blocking tenodesis, arthroscopic tenodesis
- Keywords
- rotator cuff, biceps, long biceps tendon
- 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.
self-blocking tenodesisProcedure or surgery
the LHB tendon is detached from its origin in 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 later localization of the LHB tendon during imaging (3-0 stainless steel, ethicon).
arthroscopic tenodesisProcedure or surgery
LHB tendon is detached from its origin, and sutured. Next, the LHB tendon is fixed in the bicipital groove using a 360-lasso loop tenodesis technique. 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-blocking tenodesis | Experimental | Not described Receives: Procedure: self-blocking tenodesis |
| arthroscopic tenodesis | Active comparator | Not described Receives: Procedure: arthroscopic tenodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant score (CMS)
The CMS is a 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, there 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
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 posted14 Jan 2025
- Study start22 Jan 2025
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Jan 2028 (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 Rotator Cuff InjuryStudies 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
- 100 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
- NCT06774820
- Sponsor's protocol ID
- 2024-25-CGA
- Other IDs
- 2024-A02166-41
- Acronym
- BLAST 1
- Status last verified
- Jul 2026
- First submitted
- 9 Jan 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shirinskiy IJ, Boulidam D, Macken AA, van den Bekerom MPJ, Lafosse T, Buijze GA. Biceps lasso loop and self-locking tenodesis alongside repair of rotator cuff tears: randomised controlled trial study protocol (BLAST 1). BMJ Open. 2025 Nov 19;15(11):e106475. doi: 10.1136/bmjopen-2025-106475.
PubMed 41263857
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biceps Lasso Loop and Self- Locking Tenodesis Alongside Repair of Rotator Cuff Tears: Randomised Controlled Trial Study Protocol (BLAST 1)
- ClinicalTrials.gov ID
- NCT06774820
- Acronym / sponsor ID
- BLAST 1 / 2024-25-CGA
- Conditions
- Rotator Cuff Injury
- Keywords
- rotator cuff, biceps, long biceps tendon
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Clinique Générale dAnnecyUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 14 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.
The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double 360 lasso loop biceps tenodesis for the treatment of long chief of biceps or superior labrum anterior-posterior (SLAP) tendon pathology during shoulder arthroscopy in patients undergoing arthroscopic rotator cuff repair. 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. 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. Given its potential advantages, self-locking biceps tenodesis could emerge as 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 to choose the most appropriate treatment for their patients suffering from 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-blocking tenodesis | Experimental | Procedure: self-blocking tenodesis |
| arthroscopic tenodesis | Active comparator | Procedure: arthroscopic tenodesis |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Rotator cuff tear: confirmed preoperative diagnosis of a non- traumatic, full- thickness tear of the supraspinatus and/or infraspinatus and/or subscapularis tendon, as evidenced by ultrasound, arthro- CT or MRI.
- Language proficiency: sufficient to allow for communication during the informed consent process and for the completion of the study questionnaires.
Key exclusion criteria (12 listed)
- Tear type: partial thickness rotator cuff tears are excluded.
- Tear severity: individuals with massive or irreparable rotator cuff tears are excluded.
- Fatty degeneration: presence of rotator cuff muscle fatty degeneration classified as Grade 4 according to the Goutallier system will result in exclusion.
- Glenohumeral osteoarthritis: patients exhibiting glenohumeral osteoarthritis, defined radiographically by the presence of joint space narrowing or osteophytes on anteroposterior (radiographs of the affected shoulder) will be excluded.
- Prior shoulder surgery: history of previous surgical intervention on the affected shoulder will result in exclusion.
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-blocking tenodesisthe LHB tendon is detached from its origin in 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 later localization of the LHB tendon during imaging (3-0 stainless steel, ethicon). | Procedure or surgery | self-blocking tenodesis |
| arthroscopic tenodesisLHB tendon is detached from its origin, and sutured. Next, the LHB tendon is fixed in the bicipital groove using a 360-lasso loop tenodesis technique. 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 | arthroscopic tenodesis |
Primary outcome
Constant score (CMS)
Time frame: 1 year after surgery
The CMS is a 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, there 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
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 11 Sep 2026.
- Derived from this study: PubMed 41263857Shirinskiy IJ, Boulidam D, Macken AA, van den Bekerom MPJ, Lafosse T, Buijze GA. Biceps lasso loop and self-locking tenodesis alongside repair of rotator cuff tears: randomised controlled trial study protocol (BLAST 1). BMJ Open. 2025 Nov 19;15(11):e106475. doi: 10.1136/bmjopen-2025-106475.
- 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.
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-blocking tenodesis and arthroscopic tenodesis in people with Rotator Cuff Injury, 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 12 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 11 Sep 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 6 69 96 27 33, 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 (CMS) (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 NCT06774820, 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 11 Sep 2026.