Meniscal Root Tears: Evaluation Using an Ultrahigh MRI

NCT ID: NCT05088525

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-20
• Study Completion Date: 2024-11-15

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.

Detailed Description

Studies have reported that the most common reason why patients require total knee arthroplasty before the age of 60 is a neglected or meniscectomized medial meniscus root tear. Overall, it has been noted that meniscal root repairs are cost effective and that the outcomes of meniscus root repairs are demonstrating patients have a significant improvement of their preoperative symptoms up to several years after surgery. Because most centers have only been preforming meniscus root repairs over the last five to ten years, we are now starting to recognize why some of the repairs do not function as well as others. The number one reason appears to be due to a postoperative meniscus extrusion. Meniscus extrusion has been seen in up to 50% of postoperative patients, and biomechanical studies have demonstrated that the cushioning effect of the medial meniscus does not function as well when there is a meniscus extrusion present. New biomechanical studies have demonstrated that the addition of a peripheral stabilization suture at the far posteromedial aspect of the medial tibial plateau helps to hold the meniscus better in the joint and that it also results in a significant decrease in load on the medial compartment. However, clinical studies are lacking to date as to whether a peripheral stabilization suture may or may not improve the protected function of the medial meniscus, decreased extrusion, and potentially lead to a less amount of progression of osteoarthritis in the medial compartment of the knee.

Therefore, this study strives to both assess the ability of a meniscus root repair to slow down the progression of arthritis of the medial compartment of patients with a 7-Tesla MRI scanner and also to concurrently assess the ability of the usage of a transtibial peripheral stabilization suture to decrease or eliminate meniscal extrusion. The importance of this study is that if the peripheral stabilization suture is noted to both decrease the progression of arthritis and also to decrease the meniscus extrusion, it will be a significant step forward in the treatment of these complex meniscal tears.

Conditions

Knee Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Two-tunnel meniscal root repair without a peripheral stabilization suture

Standard root repair surgery.

Group Type: ACTIVE_COMPARATOR

MRI

Intervention Type: 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

Meniscus root repair with an added stabilization suture

Group Type: EXPERIMENTAL

MRI

Intervention Type: 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.

Interventions

MRI

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• < 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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Twin Cities Orthopedics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert F LaPrade, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Twin Cities Orthopedics

Locations

Twin Cities Orthopedics

Edina, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40901697 (View on PubMed)

Other Identifiers

RFL_UMN-7T MRI

Identifier Type: -

Identifier Source: org_study_id