Clinical trial NCT06815796: Loop Vs. Anchor Tenodesis of the Long Head of the Biceps Brachii Tendon
Official title: Loop Vs. Anchor Tenodesis of the Long Head of the Biceps Brachii Tendon. a Prospective, Randomized, Double-blinded Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Biceps Tendon Disorder
Shoulder Arthroscopic Surgery
Keywords: Biceps Tendon Pathology
Arthroscopic Tenodesis
Loop Tenodesis
Suture Anchor Tenodesis
Clinical outcomes
Return to sport
Lead sponsor: Krankenhaus Barmherzige Schwestern Linz
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized allocation to 2 groups.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Constant-Murley Score
timeFrame: up to 24 months
measure: American Shoulder and Elbow Surgeons score (ASES)
timeFrame: up to 24 months
measure: Disabilities of the arm, shoulder and hand (DASH) outcome questionnaire
timeFrame: up to 24 months
Secondary outcomes:
measure: Cosmetic Outcome
timeFrame: up to 24 months
measure: Strength
timeFrame: up to 24 months
measure: Complications
timeFrame: up to 24 months
measure: Pain (pre-/postOP)
timeFrame: up to 24 months
measure: Sport activities
timeFrame: up to 24 months
measure: Level of sport
timeFrame: up to 24 months
measure: Sport duration
timeFrame: up to 24 months
measure: Return to sport
timeFrame: up to 24 months
measure: Pain during sport
timeFrame: up to 24 months
measure: Fear during sport
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Ordensklinikum Linz Barmherzige Schwestern
Study officials:
References: