CompletedNot Applicable

Restoring the Anatomic Tension Relationship of the Long Head of the Biceps During Tenodesis

United States204 participantsStarted 2020-10-27

Plain-language summary

The goal of this clinical trial is to determine the clinical impact of restoring the anatomic-tension relationship of the long head of the biceps (LHB) when performing a biceps tenotomy and tenodesis. The main question it aims to answer is whether anatomic tensioning will improve functional outcome scores and decrease postoperative complications. The investigators hypothesize that through a standardized method of anatomically tensioning the LHB tendon during tenodesis, patient outcomes will improve. Researchers will compare these outcomes to a control group receiving the traditional tensioning technique. Participants will be randomized to either the anatomic tensioning treatment group or the traditional tensioning control group.

Who can participate

Age range

18 Years

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: * Patients at least 18 years of age undergoing arthroscopic shoulder surgery * Operations that occur at Loyola University Medical Center (Maywood, IL), Loyola Ambulatory Surgery Center (Maywood, IL), or Gottlieb Memorial Hospital Exclusion Criteria: * Previous shoulder surgery involving the long head of the biceps tendon * Younger than 18 years old * Current pregnancy. As per standard protocol with all surgeries, a urine pregnancy test is performed prior to surgery. If positive, the surgery will be cancelled and the patient will be excluded from the research study.

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

Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups

Timeframe: 6 weeks

Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups

Timeframe: 3 months

Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups

Timeframe: 6 months

Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups

Timeframe: 1 year

Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups

Timeframe: 1.5 years

Trial details

NCT IDNCT06571695

SponsorLoyola University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-20

Results submitted2024-09-18

View on ClinicalTrials.gov More Biceps Tendon Disorder trials

Plain-language summary

Who can participate

Age range

18 Years

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.

What they're measuring

Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups

Timeframe: 6 weeks

Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups

Timeframe: 3 months

Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups

Timeframe: 6 months

Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups

Timeframe: 1 year

Comparison of American Shoulder and Elbow Surgeon (ASES) Score Between Treatment and Control Groups

Timeframe: 1.5 years