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NCT Number: NCT06774820

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

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.

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Key information

Conditions

Rotator Cuff Injury Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Générale

Annecy, 74000, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

self-blocking tenodesis

Procedure

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 tenodesis

Procedure

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Geert Alexander Buijze, MD

CONTACT

[email protected]

+33 6 69 96 27 33

Sponsors and collaborators

Lead sponsor

Clinique Générale dAnnecy

Other

Registry information

Acronym: BLAST1

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 14, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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