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

NCT06815796 | Active Not Recruiting

• 1 other identifier: EK 1249/2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Biceps Tendon Disorder; Shoulder Arthroscopic Surgery

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Cosmetic Outcome

  up to 24 months

• Strength

  up to 24 months

• Complications

  up to 24 months

• Pain (pre-/postOP)

  up to 24 months

• Sport activities

  up to 24 months

Study Arms (2)

Loop tenodesis of Long head of biceps tendon

EXPERIMENTAL

Long head of biceps tenodesis using loop technique

Procedure: Arthroscopic Loop tenodesis of long head of biceps.

Anchor tenodesis of Long head of biceps tendon

ACTIVE COMPARATOR

Long head of biceps tenodesis using anchor technique

Procedure: Anchor Tenodesis of Long head of biceps tendon

Interventions

Arthroscopic Loop tenodesis of long head of biceps. PROCEDURE

Loop tenodesis of the long head of biceps tendon.

Loop tenodesis of Long head of biceps tendon

Anchor Tenodesis of Long head of biceps tendon PROCEDURE

Anchor Tenodesis of Long head of biceps tendon

Anchor tenodesis of Long head of biceps tendon

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Krankenhaus Barmherzige Schwestern Linz: lead

Study Sites (1)

Ordensklinikum Linz Barmherzige Schwestern

Linz, 4020, Austria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized allocation to 2 groups.

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: February 7, 2025
• Study Start: January 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: April 30, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)