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Procedure

Bankart + Remplissage Procedure for Shoulder Dislocation (REDUCE Trial)

N/A

Recruiting

Led By Moin Khan, MD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

REDUCE Trial Summary

This trial seeks to compare surgery vs. non-surgical methods to help people who have had a first-time shoulder dislocation over 2 years.

Who is the study for?

This trial is for men and women aged 14-50 who've had a first-time shoulder dislocation confirmed by X-rays or physical exam. It's not for those with previous shoulder surgery, bone defects in the glenoid, contraindications to anesthesia, pregnancy, nursing mothers, inability to have surgery, other serious injuries like full cuff tears, risk of incarceration or delayed treatment over 90 days post-dislocation.Check my eligibility

What is being tested?

The study compares arthroscopic soft tissue stabilization (Bankart + Remplissage Procedure) against non-surgical treatments in patients after their first shoulder dislocation. The goal is to see which method better prevents future dislocations and improves function over two years.See study design

What are the potential side effects?

Potential side effects may include pain at the surgical site, infection risks from surgery or anesthesia complications. Non-surgical interventions might lead to less immediate discomfort but could result in higher rates of re-injury.

REDUCE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Crossovers

Follow-up

Recruitment Feasibility

+1 more

Secondary outcome measures

Adverse events

Clinical Outcome

Clinical Outcome - Quality of Life

+10 more

REDUCE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bankart repair + RemplissageExperimental Treatment1 Intervention

Arthroscopic repair of anterior capsulo-labral structures

Group II: Conservative treatmentActive Control1 Intervention

Non surgical intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor

884 Previous Clinical Trials

2,598,266 Total Patients Enrolled

2 Trials studying Sports Injuries

208 Patients Enrolled for Sports Injuries

Moin Khan, MDPrincipal InvestigatorMcMaster University

4 Previous Clinical Trials

468 Total Patients Enrolled

2 Trials studying Sports Injuries

208 Patients Enrolled for Sports Injuries

Media Library

Bankart +/- Remplissage Procedure (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05715021 — N/A

Sports Injuries Research Study Groups: Conservative treatment, Bankart repair + Remplissage

Sports Injuries Clinical Trial 2023: Bankart +/- Remplissage Procedure Highlights & Side Effects. Trial Name: NCT05715021 — N/A

Bankart +/- Remplissage Procedure (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05715021 — N/A

Frequently Asked Questions

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

Would I be eligible for involvement in this experiment?

"To be eligible for the trial, participants need to have sustained sporting injuries and must fall between 14-50 years of age. Altogether, 50 people are being recruited into this experiment."

Answered by AI

Does this research project extend to participants aged 45 or older?

"To be eligible for this medical research, participants should fall within the age range of 14 and 50. There are 31 studies available for minors and 32 specifically geared towards those aged 65 or older."

Answered by AI

Is this research endeavor presently looking to enroll participants?

"The clinical trials database states that this trial is no longer recruiting. First posted on July 12th 2023 and last edited the following day, it has since been removed from active recruitment status. However, there are still 67 other studies with open enrollment criteria available to patients at present time."

Answered by AI

What are the ultimate objectives of this clinical experiment?

"This 2 year medical trial will assess Recruitment Feasibility and other secondary goals, such as patient satisfaction (measured by a 0 to 10 questionnaire), rate of recurrence between those receiving surgical intervention or conservative treatment, and pain scores taken from a visual analog scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

RCT Evaluating First Time Shoulder Dislocation

Moin Khan 2023. "RCT Evaluating First Time Shoulder Dislocation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05715021.