Biceps Lasso Loop and Self- Locking Tenodesis Alongside Repair of Rotator Cuff Tears: Randomised Controlled Trial Study Protocol (BLAST 1) (BLAST 1)

September 9, 2026 updated by: Clinique Générale dAnnecy
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Annecy, France, 74000
        • Recruiting
        • Clinique Générale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: self-blocking tenodesis
Procedure: self-blocking tenodesis
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).
Active Comparator: arthroscopic tenodesis
Procedure: arthroscopic tenodesis
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Shoulder and Elbow Surgeons Score
Time Frame: 6 weeks, 3 months, 6 months, 1 year after surgery
The ASES is a 100-point scale comprising 2 assessment dimensions: pain and activities of daily living.
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
The SSV is a single-question assessment of the patient's perceived shoulder function expressed as a percentage of normal.
6 weeks, 3 months, 6 months, 1 year after surgery
LHB score
Time Frame: 6 months, 1 year after surgery
The LHB score assesses symptoms and function related to long head of the biceps tendon pathology.
6 months, 1 year after surgery
Cosmetic appearance
Time Frame: 6 weeks, 3 months, 6 months, 1 year after surgery
Cosmetic appearance will be assessed by both the patient and the clinician using standardized photographs.
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
Pain intensity will be assessed using a visual analogue scale (VAS) at rest, during activity, and over the bicipital groove.
6 weeks, 3 months, 6 months, 1 year after surgery
Radiograph
Time Frame: Direct post-op, 6 weeks, 3 months, 6 months after surgery
Standardized radiographs will assess postoperative migration of the long head of the biceps tendon using a radio-opaque marker.
Direct post-op, 6 weeks, 3 months, 6 months after surgery
MRI or Ultra-sound
Time Frame: 1 year after surgery
MRI or ultrasound will assess the postoperative position of the long head of the biceps tendon at final follow-up.
1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Générale dAnnecy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2025

Primary Completion (Estimated)

November 15, 2027

Study Completion (Estimated)

January 15, 2028

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

January 14, 2025

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-25-CGA
  • 2024-A02166-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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