Biceps Tenodesis with 360 Suture Anchor Versus Self Locking Tenodesis in the Absence of Rotator Cuff Tears

NCT06772103 | Recruiting

• 1 other identifier: 2024-43-CGA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

biceps; tenodesis; imaging; tendon repair

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year after surgery

Study Arms (2)

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

Interventions

self-locking biceps tenodesis PROCEDURE

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).

self-locking biceps tenodesis

Biceps Tenodesis with 360 Suture anchor PROCEDURE

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).

360° double-loop lasso biceps tenodesis

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tendinopathy of the Long Head of the Biceps based on clinical symptoms or SLAP-type lesion
• Partial thickness rupture or absence of rupture of the rotator cuff of the subscapular, supraspinatus and/or infraspinatus tendons, diagnosed preoperatively on ultrasound, arthro-CT or MRI.

You may not qualify if:

• Osteoarthritis of the glenohumeral joint, defined by narrowing of the glenohumeral joint space or osteophytes, using AP radiography of the affected shoulder.
• Distance between acromion and humeral head measuring 6 mm or less
• Previous shoulder surgery.
• Dementia or inability to complete questionnaires and assessments.
• Pregnant or breast-feeding patient
• Protected adult patient
• Patient not covered by social security.

Sponsors & Collaborators

• Clinique Générale dAnnecy: lead

Study Sites (1)

Clinique Générale

Annecy, 74000, France

RECRUITING

Central Study Contacts

Geert Alexander Buijze, MD

CONTACT

+33 669962733; gabuijze@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: January 22, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)