Meniscal Root Tears: Evaluation Using an Ultrahigh MRI

NCT05088525 | Completed

• 1 other identifier: RFL_UMN-7T MRI
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Meniscal root tears have been recently recognized to be one of the most common causes for the progression of arthritis in relatively young patients. The purpose of the study will be to assess if the addition of a transtibial peripheral stabilization suture helps to decrease both meniscal extrusion and if it helps to decrease the progression of osteoarthritis of the medial compartment of the knee in the early timeframe postoperatively.

Conditions

Knee Injuries

Keywords

Meniscal Root; MRI

Outcome Measures

Primary Outcomes (2)

• MRI

  Musculoskeletal radiologist assessment of medial meniscus extrusion and cartilage specific sequences gathered

  Pre-operatively

• MRI

  Musculoskeletal radiologist assessment of medial meniscus extrusion and cartilage specific sequences gathered

  6 months post-operatively

Secondary Outcomes (10)

• visual analog scale (VAS) scores

  pre-operatively and post-operatively at 3 and 6 months

• International Knee Documentation Committee (IKDC)

  pre-operatively and post-operatively at 3 and 6 months

• Cincinnati Knee Rating System

  pre-operatively and post-operatively at 3 and 6 months

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  pre-operatively and post-operatively at 3 and 6 months

• Tegner

  pre-operatively and post-operatively at 3 and 6 months

Study Arms (2)

Two-tunnel meniscal root repair without a peripheral stabilization suture

ACTIVE COMPARATOR

Standard root repair surgery.

Procedure: MRI

Meniscal root repair with an additional transtibial peripheral stabilization suture

EXPERIMENTAL

Meniscus root repair with an added stabilization suture

Procedure: MRI

Interventions

MRI PROCEDURE

MRI for standard of care meniscus root repair surgery - noting with an added stabilization suture if it is able to successfully slow down the progression of osteoarthritis versus a standard root repair surgery.

Meniscal root repair with an additional transtibial peripheral stabilization suture; Two-tunnel meniscal root repair without a peripheral stabilization suture

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Between ages 14-70 years old
• Has suspected meniscus root tear
• Able to consent for themselves for adults
• English speaking
• Males or females
• Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.

You may not qualify if:

• \< 14 years old or open physes
• \>70 years old
• Pregnant
• Previous or concurrent vascular injury (vascular bypass procedure)
• Associated fractures requiring concurrent surgery
• Found to have contraindications to MRI based on a systematic safety screening developed by the CMRR

Sponsors & Collaborators

• Twin Cities Orthopedics: lead

Study Sites (1)

Twin Cities Orthopedics

Edina, Minnesota, 55435, United States

Location

Related Publications (1)

• Tollefson LV, Kajabi AW, Hedayati E, Knutsen K, Takahashi T, Ellermann J, LaPrade RF. Medial Meniscal Extrusion Increased on 6-Month Magnetic Resonance Imaging, Despite Successful Posterior Root Repair With or Without a Centralization Suture: A Randomized Controlled Clinical Trial. Am J Sports Med. 2025 Oct;53(12):2808-2816. doi: 10.1177/03635465251366443. Epub 2025 Sep 3.

  PMID: 40901697 DERIVED

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Robert F LaPrade, MD, PhD

  Twin Cities Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 22, 2021
• Study Start: November 20, 2020
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)