An interventional study of self-blocking tenodesis and arthroscopic tenodesis in Rotator Cuff Injury, sponsored by Clinique Générale dAnnecy. Recruiting at 1 site in France. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Clinique Générale dAnnecy · Not applicable, Interventional, and Treatment
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.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 456 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Clinique Générale dAnnecy is the lead sponsor of 8 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: self-blocking tenodesis
Procedure: arthroscopic 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).
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).
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.
Time frame: 1 year after surgery
American Shoulder and Elbow Surgeons Score
The ASES is a 100-point scale comprising 2 assessment dimensions: pain and activities of daily living.
Time frame: 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.
Time frame: 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.
Time frame: 6 months, 1 year after surgery
Cosmetic appearance
Cosmetic appearance will be assessed by both the patient and the clinician using standardized photographs.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year after surgery
Plan to share: No
Started Jan 2025 (actual). Primary completion is estimated for Nov 2027, 33 months after the start.
Of 228 non-industry interventional studies with no phase under Rotator Cuff Injuries, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 33 months is above that.
Counting every sponsor, half of 252 studies reached it within 23 months; a quarter within 11 and three quarters within 44.
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