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Procedure

Shoulder Surgery for Shoulder Injury

N/A

Recruiting

Led By Alexandre Lädermann, MD

Research Sponsored by La Tour Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 2 postoperative years

Awards & highlights

Study Summary

This trial compares the effectiveness of two shoulder surgeries for treating shoulder pain caused by a damaged tendon: tenotomy and tenodesis. Both have advantages and disadvantages, but no clear winner has been determined.

Who is the study for?

This trial is for individuals aged 50-80 with a full thickness tear of the supraspinatus tendon, an intact subscapularis tendon, and who are undergoing primary rotator cuff repair. Participants must be able to consent, complete questionnaires, attend follow-ups, and adhere to post-op therapy. Excluded are those with judgment impairments, language barriers, psychological disorders or dementia.Check my eligibility

What is being tested?

The study compares two procedures for shoulder pain associated with rotator cuff issues: LHB Tenotomy (cutting off the biceps tendon) and LHB Tenodesis (reattaching it). It aims to determine which leads to better outcomes—pain relief and function—or if leaving the tendon intact is just as effective.See study design

What are the potential side effects?

Potential side effects from these procedures may include reduced elbow flexion strength, cosmetic changes in arm appearance due to muscle repositioning or bulging ('Popeye' deformity), pain at surgery site, infection risk and possible need for additional surgeries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 2 postoperative years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 2 postoperative years

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2 postoperative years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

ASES score

Secondary outcome measures

AFF

Complications

ER at side

+13 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: LHB tenotomyExperimental Treatment1 Intervention

The long head of the biceps (LHB) will be cut at its origin.

Group II: LHB TenodesisExperimental Treatment1 Intervention

The long head of the biceps (LHB) will be cut at its origin and reattached.

Group III: Leaving LHB IntactActive Control1 Intervention

The long head of the biceps (LHB) will be left intact.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LHB Tenotomy

2012

N/A

~100

LHB Tenodesis

2012

N/A

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

La Tour HospitalLead Sponsor

14 Previous Clinical Trials

245,964 Total Patients Enrolled

Alexandre Lädermann, MDPrincipal InvestigatorLa Tour Hospital

5 Previous Clinical Trials

5,409 Total Patients Enrolled

Media Library

LHB Tenodesis (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05660031 — N/A

Supraspinatus Tear Research Study Groups: LHB Tenodesis, Leaving LHB Intact, LHB tenotomy

Supraspinatus Tear Clinical Trial 2023: LHB Tenodesis Highlights & Side Effects. Trial Name: NCT05660031 — N/A

LHB Tenodesis (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05660031 — N/A

Frequently Asked Questions

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

Does the trial accept participants who are younger than 30 years of age?

"As per the stipulations of this medical trial, participants must be between 50 and 80 years old."

Answered by AI

Are new volunteers being accepted for this experiment?

"Affirmative. Clinicaltrials.gov records reveal that this medical trial, initially posted on June 1st 2021, is currently searching for subjects to enrol in the study. A total of 180 individuals will be accepted between 3 distinct sites."

Answered by AI

How many participants have been selected to join this experiment?

"This trial requires 180 volunteers who meet the necessary qualifications. Enrolment can take place at Oregon Health & Science University in Portland and Group 23 Sports Medicine, located in Calgary."

Answered by AI

To which populations is this experiment open?

"This clinical trial necessitates 180 eligible participants aged between 50 and 80 who have lipocalin 1. In addition, they must be of sound mental and physical health to partake in the study's activities, fill out surveys, make follow-up visits, adhere to post-operative physical therapy regimens; suffer a full thickness tear of the supraspinatus tendon with an intact subscapularis tendon needing primary rotator cuff repair as well as provide their voluntary consent prior to joining."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of the Biceps With Concomitant Supraspinatus Tears

Dr. Alexandre Lädermann 2021. "Treatment of the Biceps With Concomitant Supraspinatus Tears". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05660031.