CompletedNot Applicable

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

Austria50 participantsStarted 2023-01-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Constant-Murley Score

Timeframe: up to 24 months

American Shoulder and Elbow Surgeons score (ASES)

Timeframe: up to 24 months

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

Timeframe: up to 24 months

Trial details

NCT IDNCT06815796

SponsorKrankenhaus Barmherzige Schwestern Linz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-31

View on ClinicalTrials.gov More Biceps Tendon Disorder trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.