Skip to main content
OpenTrials
Completed

NCT Number: NCT06815796

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ordensklinikum Linz Barmherzige Schwestern

Linz, 4020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Arthroscopic Loop tenodesis of long head of biceps.

Procedure

Loop tenodesis of the long head of biceps tendon.

Anchor Tenodesis of Long head of biceps tendon

Procedure

Anchor Tenodesis of Long head of biceps tendon

Primary outcomes

  1. Constant-Murley Score

    Time frame: up to 24 months

    score ranges from 0 to 100 points, representing worst and best shoulder function

  2. American Shoulder and Elbow Surgeons score (ASES)

    Time frame: up to 24 months

    ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function

  3. Disabilities of the arm, shoulder and hand (DASH) outcome questionnaire

    Time frame: up to 24 months

    scored 0 (no disability) to 100

Secondary outcomes

  1. Cosmetic Outcome

    Time frame: up to 24 months

    Incidence of "Popeye deformity" post-surgery

  2. Strength

    Time frame: up to 24 months

    Supination of the forearm in 90 degree elbow flexion in kilogram

  3. Complications

    Time frame: up to 24 months

    Rate of complications (anchor failure, Pop-eye deformity, infections, pain etc.)

  4. Pain (pre-/postOP)

    Time frame: up to 24 months

    assessed using a Visual Analog Scale (VAS). two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')

  5. Sport activities

    Time frame: up to 24 months

    assessed using a questionnaire

  6. Level of sport

    Time frame: up to 24 months

    assessed using a questionnaire (amateur (no salary), professional (salary)

  7. Sport duration

    Time frame: up to 24 months

    assessed 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)

  8. Return to sport

    Time frame: up to 24 months

    assessed using a questionnaire (months)

  9. Pain during sport

    Time frame: up to 24 months

    assessed using a questionnaire with virtual analag scale (pre- and postOP; VAS 0-10, 0= no pain, 10= maximal pain)

  10. Fear during sport

    Time frame: up to 24 months

    assessed using a questionnaire with virtual analog scale (pre- and postOP; VAS 0-10, 0= no fear, 10= maximal fear)

Sponsors and collaborators

Lead sponsor

Krankenhaus Barmherzige Schwestern Linz

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 7, 2025
Registry last updated
Jun 3, 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.

Published trials that share one or more normalized conditions with this study.