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Tenodesis vs. Tenotomy for Biceps Tendon Lesions

N/A

Recruiting

Led By Laith Jazrawi, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary indication is for pathology of the LHBT or biceps-labrum complex

Age 40-80

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post-op, 24 months post-op

Awards & highlights

Study Summary

This trial will compare two surgical treatments for a common complication after surgery to repair the biceps tendon.

Who is the study for?

This trial is for individuals aged 40-80 with lesions in the long head of the biceps tendon or biceps-labrum complex. They must be able to follow a post-op plan and give consent. It's not for those under 40, pregnant, with prior shoulder surgery, rotator cuff tears needing repair, or unable to consent.Check my eligibility

What is being tested?

The study compares two surgical methods for treating biceps tendon lesions: Biceps Tenodesis and Self-locking 'T' Tenotomy. The goal is to see if self-locking tenotomy can reduce Popeye deformity while offering faster recovery and lower costs than tenodesis.See study design

What are the potential side effects?

Possible side effects include development of a Popeye deformity (bulging of the bicep), pain at the surgery site, limited range of motion temporarily after surgery, and potential complications from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My main issue is with my biceps tendon or its attachment in the shoulder.

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I am between 40 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post-op, 24 months post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post-op, 24 months post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-op, 24 months post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Reverse Popeye Deformity

Secondary outcome measures

Average timing of return to work/sport

Change in Score on American Shoulder & Elbow Surgeons (ASES) Scale

Change in Score on Visual Analogue Scale (VAS)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Biceps self-locking "T" tenotomyExperimental Treatment1 Intervention

Group II: Biceps tenodesis (control)Active Control1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,368 Previous Clinical Trials

839,629 Total Patients Enrolled

Laith Jazrawi, MDPrincipal InvestigatorNYU Langone Health

3 Previous Clinical Trials

175 Total Patients Enrolled

Media Library

Biceps Tenodesis Clinical Trial Eligibility Overview. Trial Name: NCT04468906 — N/A

Tenodesis Research Study Groups: Biceps self-locking "T" tenotomy, Biceps tenodesis (control)

Tenodesis Clinical Trial 2023: Biceps Tenodesis Highlights & Side Effects. Trial Name: NCT04468906 — N/A

Biceps Tenodesis 2023 Treatment Timeline for Medical Study. Trial Name: NCT04468906 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which participants are eligible to join this clinical experiment?

"Candidates between 40 and 80 years old who have undergone tenotomy are eligible to apply for this clinical trial, with a maximum of 110 accepted participants."

Answered by AI

Are persons of advanced age included in the parameters for participation in this medical experiment?

"This research is seeking individuals aged between 40 and 80 years old."

Answered by AI

Is enrollment currently being accepted for this clinical trial?

"Affirmative. Clinicaltrials.gov attests that this study, published on September 1st 2020 and last amended November 18th 2022, is actively seeking out patients to recruit - 110 at a single site in total."

Answered by AI

What is the aggregate number of participants in this trial?

"Affirmative. Clinicaltrials.gov reflects that this clinical trial has been actively recruiting since it was first published on September 1st 2020 and the listing was most recently edited on November 18th 2022. The study seeks to enrol a total of 110 participants from one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tenodesis vs. Self-locking Tenotomy in Long Head of the Biceps Tendon Lesions: A Randomized Clinical Trial

2020. "Tenodesis vs. Self-locking Tenotomy in Long Head of the Biceps Tendon Lesions: A Randomized Clinical Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04468906.