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Loop vs. Anchor Tenodesis of the Long Head of the Biceps Brachii Tendon

Loop vs. Anchor Tenodesis of the Long Head of the Biceps Brachii Tendon. A Prospective, Randomized, Double-blinded Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06815796
Enrollment
50
Registered
2025-02-07
Start date
2023-01-01
Completion date
2025-04-30
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biceps Tendon Disorder, Shoulder Arthroscopic Surgery

Keywords

Biceps Tendon Pathology, Arthroscopic Tenodesis, Loop Tenodesis, Suture Anchor Tenodesis, Clinical outcomes, Return to sport

Brief summary

The goal of this clinical trial is to learn if loop tenodesis is as effective as suture anchor tenodesis for treating long head of biceps (LHB) pathology. It will also assess the safety and outcomes of both techniques. The main questions it aims to answer are: How effective is loop tenodesis compared to suture anchor tenodesis in preventing shoulder deformities and maintaining biomechanical strength? What complications or failures occur with each technique? Researchers will compare suture anchor tenodesis using the Arthrex FiberTak system with loop tenodesis (an implant-free technique). Participants will: Undergo surgery with either suture anchor tenodesis or loop tenodesis, assigned randomly. Be informed about the procedure and sign a consent form prior to surgery. Have their clinical outcomes evaluated and compared before and after their treatment.

Detailed description

A pathology of the long head of the biceps tendon (LHB) is often the cause of shoulder pain. There are numerous ways to treat an LHB pathology. Arthroscopic biceps tenotomy is a simple method to address this condition. However, it often results in a cosmetic "Popeye deformity" and reduced strength during abduction. For this reason, and due to advancements in anchor systems, arthroscopic biceps tenodesis using an anchor in the bicipital groove is becoming increasingly popular. The advantage of this method is that it prevents potential muscle deformity and provides stable fixation in the bicipital groove. Possible disadvantages include potential failure and the cost of the anchors used. A newer method with good biomechanical and clinical outcomes is the so-called arthroscopic loop tenodesis. In this technique, the LHB is proximally detached at its insertion and shuttled extracapsularly using a clamp. The end of the tendon is then folded and sutured into a so-called "loop." The tendon is released, and after spontaneous retraction, it forms a so-called autotenodesis in the bicipital groove. This technique has the advantage of providing implant-free fixation while also demonstrating good biomechanical outcomes. The goal of this study is to investigate and compare the clinical success rate after arthroscopic treatment of the LHB using either a suture anchor tenodesis (Arthrex FiberTak) or the so-called loop tenodesis (implant-free fixation). The study is being conducted in the Orthopedics Department of the Ordensklinikum Linz - Barmherzige Schwestern, Austria. All patients requiring arthroscopic biceps tenodesis at the Orthopedics Department of the Ordensklinikum Linz will be treated using either suture anchor tenodesis or loop tenodesis. Allocation to the surgical technique will be determined by block randomization (block length = 9) immediately after the decision to include the patient in the study. Block randomization using a random number generator is chosen to ensure that the group sizes are approximately equal. Before surgery, patients will be informed about the study process and the possibility of participation during a personal consultation. They will also receive a patient information and consent form in which their agreement to participate is documented in writing. Patients will receive a copy of the signed consent form, while the original remains with the investigator. The data collected in this study will be analyzed individually and compared with existing data in the literature. The results will then be taken into account when considering various treatment concepts, potentially leading to adjustments or optimizations to benefit the patients.

Interventions

PROCEDUREArthroscopic Loop tenodesis of long head of biceps.

Loop tenodesis of the long head of biceps tendon.

PROCEDUREAnchor Tenodesis of Long head of biceps tendon

Anchor Tenodesis of Long head of biceps tendon

Sponsors

Krankenhaus Barmherzige Schwestern Linz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Randomized allocation to 2 groups.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* All patients requiring a tenodesis of the long head of the biceps tendon during the study period, using either anchor tenodesis or loop tenodesis. * Patients must be at least 18 years old. * Patients must have the capacity to give informed consent.

Exclusion criteria

* Patients with insufficient documentation. * Patients under the age of 18.

Design outcomes

Primary

MeasureTime frameDescription
Constant-Murley Scoreup to 24 monthsscore ranges from 0 to 100 points, representing worst and best shoulder function
American Shoulder and Elbow Surgeons score (ASES)up to 24 monthsranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function
Disabilities of the arm, shoulder and hand (DASH) outcome questionnaireup to 24 monthsscored 0 (no disability) to 100

Secondary

MeasureTime frameDescription
Cosmetic Outcomeup to 24 monthsIncidence of "Popeye deformity" post-surgery
Strengthup to 24 monthsSupination of the forearm in 90 degree elbow flexion in kilogram
Complicationsup to 24 monthsRate of complications (anchor failure, Pop-eye deformity, infections, pain etc.)
Pain (pre-/postOP)up to 24 monthsassessed using a Visual Analog Scale (VAS). two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Sport activitiesup to 24 monthsassessed using a questionnaire
Level of sportup to 24 monthsassessed using a questionnaire (amateur (no salary), professional (salary)
Sport durationup to 24 monthsassessed using a questionnaire (1x/2x/3x/4x/\>4x per week; 0-15 min, 16-30 min, 31-60 min, 61-120 min, \> 120 min per day)
Return to sportup to 24 monthsassessed using a questionnaire (months)
Pain during sportup to 24 monthsassessed using a questionnaire with virtual analag scale (pre- and postOP; VAS 0-10, 0= no pain, 10= maximal pain)
Fear during sportup to 24 monthsassessed using a questionnaire with virtual analog scale (pre- and postOP; VAS 0-10, 0= no fear, 10= maximal fear)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026