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Procedure

Arthroscopic Stabilization vs Latarjet Procedure for Shoulder Dislocation

N/A
Recruiting
Led By Moin Khan, MD
Research Sponsored by Moin Khan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of post-traumatic recurrent anterior dislocation. This will require a minimum of 2 episodes of documented dislocations either by radiographic evidence or documented reduction of anterior shoulder dislocation as well as physical examination eliciting unwanted glenohumeral translation with reproduction of symptoms
Men and women ages 18-50 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is comparing two different surgeries for treating shoulder instability, measuring how well each surgery prevents recurrent shoulder dislocation and improves function over a two year period.

Who is the study for?
This trial is for adults aged 18-50 with a history of recurrent shoulder dislocation, specifically anterior dislocation confirmed by physical exam or imaging. Candidates should have mild glenoid bone loss and be able to give informed consent. It's not for those with previous shoulder surgery, epilepsy, other shoulder injuries like cuff tears, multidirectional instability, pregnancy, or certain connective tissue disorders.Check my eligibility
What is being tested?
The study compares two surgical procedures for recurrent shoulder dislocations over a period of 24 months: the Latarjet procedure (coracoid transfer) versus arthroscopic capsuloligamentous repair (Bankart + Remplissage). The goal is to see which one better prevents future dislocations and improves function.See study design
What are the potential side effects?
Potential side effects may include pain at the surgery site, infection risk from the operation, limited range of motion post-surgery, nerve damage risks associated with any surgical intervention on the joint area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My shoulder has dislocated at least twice due to an injury.
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I am between 18 and 50 years old.
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I have mild shoulder socket bone loss (10-20%).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Follow-up
Protocol Adherence
Recruitment Feasibility
Secondary outcome measures
Clinical Outcome
Rate of Recurrence

Trial Design

2Treatment groups
Experimental Treatment
Group I: Latarjet ProcedureExperimental Treatment1 Intervention
Open or Arthroscopic coracoid transfer (Latarjet Procedure): This procedure may be performed through small incisions (minimally invasive) but may require a larger incision in some cases. It involves the transfer of a nearby bony structure (the coracoid process) to the front of the shoulder joint (glenoid). This bone will then provide support to prevent the shoulder joint from dislocating.
Group II: Bankart + Remplissage ProcedureExperimental Treatment1 Intervention
Bankart Procedure: the participant will be placed in the lateral decubitus or beach chair position. Standard diagnostic arthroscopy will be performed. The anterior capsulolabral complex will be freed from the anterior aspect of the scapular neck. The anterior aspect of the scapular neck will be decorticated using a motorized burr. A capsuloligamentous repair will be performed with the capsule shifted from inferior to superior and repaired on the glenoid face. The number of anchors used for the repair will be left to the discretion of the surgeon. Patients will be given a sling for 4 weeks, and participation in sports will not be allowed for 6 months.

Find a Location

Who is running the clinical trial?

University of MichiganOTHER
1,787 Previous Clinical Trials
6,365,452 Total Patients Enrolled
1 Trials studying Shoulder Dislocation
2,500 Patients Enrolled for Shoulder Dislocation
Campus Bio-Medico UniversityOTHER
108 Previous Clinical Trials
50,862 Total Patients Enrolled
OLVGNETWORK
22 Previous Clinical Trials
55,232 Total Patients Enrolled
1 Trials studying Shoulder Dislocation
100 Patients Enrolled for Shoulder Dislocation

Media Library

Bankart + Remplissage Procedure (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03585491 — N/A
Shoulder Dislocation Research Study Groups: Bankart + Remplissage Procedure, Latarjet Procedure
Shoulder Dislocation Clinical Trial 2023: Bankart + Remplissage Procedure Highlights & Side Effects. Trial Name: NCT03585491 — N/A
Bankart + Remplissage Procedure (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03585491 — N/A

Frequently Asked Questions

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

What is the total enrollment for this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that this research endeavour, which commenced on July 1st 2019, is still seeking participants. In total 82 individuals need to be recruited from one facility for the trial to move forward."

Answered by AI

Is there a call for volunteers in this research endeavor?

"As per the information on clinicaltrials.gov, this particular investigation is presently seeking out participants. It was first published in July of 2019 and underwent its most recent revision in March 2021."

Answered by AI

Who is the ideal candidate for participating in this clinical research project?

"In order to partake in this research program, individuals should possess a shoulder injury and fall within the 18-50 year old demographic. The total number of needed participants is 82."

Answered by AI

Is the cutoff age for this medical trial fifty years or older?

"According to the requirements of this medical study, individuals aged 18-50 are eligible for enrollment. For those below 18 and above 65 years old, there are 33 clinical trials and 32 respectively."

Answered by AI
~12 spots leftby Feb 2025