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Ultrahigh MRI for Knee Injuries

N/A
Recruiting
Led By Robert F LaPrade, MD, PhD
Research Sponsored by Twin Cities Orthopedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between ages 14-70 years old
Must not have
Associated fractures requiring concurrent surgery
< 14 years old or open physes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-operatively and post-operatively at 3 and 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess if a transtibial peripheral stabilization suture helps to decrease meniscal extrusion and progression of osteoarthritis of the medial compartment of the knee.

Who is the study for?
This trial is for English-speaking males and females aged 14-70 who suspect they have a meniscus root tear in the knee. Participants must be able to consent, follow the trial plan, and sign informed consent. It excludes those under 14 or over 70, pregnant individuals, anyone with MRI contraindications or concurrent serious injuries.
What is being tested?
The study tests whether adding a stabilization suture during surgery can reduce meniscal extrusion and slow down arthritis progression in the knee after a meniscal root tear. Patients will undergo an advanced MRI to evaluate this technique's effectiveness.
What are the potential side effects?
While MRIs are generally safe, potential side effects may include discomfort from lying still during the procedure or reactions if contrast dye is used. There might also be risks associated with surgical intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 14 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need surgery for fractures related to my condition.
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I am under 14 years old or my growth plates are still open.
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I am over 70 years old.
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I have had a vascular bypass procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operatively at 3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operatively at 3 and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MRI
Secondary study objectives
Cincinnati Knee Rating System
International Knee Documentation Committee (IKDC)
Knee injury and Osteoarthritis Outcome Score (KOOS)
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Meniscal root repair with an additional transtibial peripheral stabilization sutureExperimental Treatment1 Intervention
Meniscus root repair with an added stabilization suture
Group II: Two-tunnel meniscal root repair without a peripheral stabilization sutureActive Control1 Intervention
Standard root repair surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~2810

Find a Location

Who is running the clinical trial?

Twin Cities OrthopedicsLead Sponsor
3 Previous Clinical Trials
900 Total Patients Enrolled
2 Trials studying Knee Injuries
100 Patients Enrolled for Knee Injuries
Robert F LaPrade, MD, PhDPrincipal InvestigatorTwin Cities Orthopedics
2 Previous Clinical Trials
100 Total Patients Enrolled
2 Trials studying Knee Injuries
100 Patients Enrolled for Knee Injuries

Media Library

Transtibial Peripheral Stabilization Suture Clinical Trial Eligibility Overview. Trial Name: NCT05088525 — N/A
Knee Injuries Research Study Groups: Two-tunnel meniscal root repair without a peripheral stabilization suture, Meniscal root repair with an additional transtibial peripheral stabilization suture
Knee Injuries Clinical Trial 2023: Transtibial Peripheral Stabilization Suture Highlights & Side Effects. Trial Name: NCT05088525 — N/A
Transtibial Peripheral Stabilization Suture 2023 Treatment Timeline for Medical Study. Trial Name: NCT05088525 — N/A
~6 spots leftby Nov 2025
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