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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Arthroscopic Surgery; Biceps Tendon Disorder
• Intervention / Treatment: Procedure: Arthroscopic Loop tenodesis of long head of biceps.; Procedure: Anchor Tenodesis of Long head of biceps tendon

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4020
    • Ordensklinikum Linz Barmherzige Schwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Loop tenodesis of Long head of biceps tendon; Long head of biceps tenodesis using loop technique	Procedure: Arthroscopic Loop tenodesis of long head of biceps.; Loop tenodesis of the long head of biceps tendon.
Active Comparator: Anchor tenodesis of Long head of biceps tendon; Long head of biceps tenodesis using anchor technique	Procedure: Anchor Tenodesis of Long head of biceps tendon; Anchor Tenodesis of Long head of biceps tendon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant-Murley Score	score ranges from 0 to 100 points, representing worst and best shoulder function	up to 24 months
American Shoulder and Elbow Surgeons score (ASES)	ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function	up to 24 months
Disabilities of the arm, shoulder and hand (DASH) outcome questionnaire	scored 0 (no disability) to 100	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmetic Outcome	Incidence of "Popeye deformity" post-surgery	up to 24 months
Strength	Supination of the forearm in 90 degree elbow flexion in kilogram	up to 24 months
Complications	Rate of complications (anchor failure, Pop-eye deformity, infections, pain etc.)	up to 24 months
Pain (pre-/postOP)	assessed using a Visual Analog Scale (VAS). two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')	up to 24 months
Sport activities	assessed using a questionnaire	up to 24 months
Level of sport	assessed using a questionnaire (amateur (no salary), professional (salary)	up to 24 months
Sport duration	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)	up to 24 months
Return to sport	assessed using a questionnaire (months)	up to 24 months
Pain during sport	assessed using a questionnaire with virtual analag scale (pre- and postOP; VAS 0-10, 0= no pain, 10= maximal pain)	up to 24 months
Fear during sport	assessed using a questionnaire with virtual analog scale (pre- and postOP; VAS 0-10, 0= no fear, 10= maximal fear)	up to 24 months

Collaborators and Investigators

• Sponsor: Krankenhaus Barmherzige Schwestern Linz

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): February 7, 2025

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Clinical outcomes; Return to sport; Biceps Tendon Pathology; Arthroscopic Tenodesis; Loop Tenodesis; Suture Anchor Tenodesis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: EK 1249/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD can be shared upon request, due to government privacy policy routine uploading of specific data can not be done.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No