Meniscal Root Tears: Evaluation Using an Ultrahigh MRI

Knee Injuries Clinical Trial

Official title:

Meniscal Root Tears: Evaluating Meniscal Extrusion After Root Repair With and Without Transtibial Peripheral Stabilization Sutures Using Ultrahigh Magnetic Fields: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05088525
• Other study ID #: RFL_UMN-7T MRI
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Twin Cities Orthopedics
• Contact: Becky Stone
• Phone: 952-456-7136
• Email: research[@]tcomn.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Twin Cities Orthopedics	Edina	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Twin Cities Orthopedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI	Musculoskeletal radiologist assessment of medial meniscus extrusion and cartilage specific sequences gathered	Pre-operatively
Primary	MRI	Musculoskeletal radiologist assessment of medial meniscus extrusion and cartilage specific sequences gathered	6 months post-operatively
Secondary	visual analog scale (VAS) scores	Pain scale 0-100	pre-operatively and post-operatively at 3 and 6 months
Secondary	International Knee Documentation Committee (IKDC)	The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. The higher the score, better outcomes 87/87 = 100%	pre-operatively and post-operatively at 3 and 6 months
Secondary	Cincinnati Knee Rating System	Functional assessment based on 6 abilities important for participation in sports. The higher the score, better outcomes 100/100 = 100%	pre-operatively and post-operatively at 3 and 6 months
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS)	Assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. The maximum score a patient can achieve is 100, indicating no knee problems.	pre-operatively and post-operatively at 3 and 6 months
Secondary	Tegner	the higher the score, better outcomes 100/100 = 100% The scale is numbered on a "0-10" format, with 1 being professional and 1 being a person who is disabled from knee issues.	pre-operatively and post-operatively at 3 and 6 months
Secondary	Lysholm Knee Scoring Scale	Consists of eight items that measure: pain (25 points), instability (25 points), locking (15 points), swelling (10 points), limp (5 points), stair climbing (10 points), squatting (5 points), and need for support (5 points). Every question response has been assigned an arbitrary score on an increasing scale. The total score is the sum of each response to the eight questions, and may range from 0-100.	pre-operatively and post-operatively at 3 and 6 months
Secondary	Veterans Rand 12 (VR-12) General Health Survey	VR-12 includes 12 original question items from the VR-36. The questions in this survey correspond to seven different health domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into two scores, a Physical Component Score (PCS) and a Mental Component Score (MCS) which then provides an important contrast between the respondents' physical and psychological health status. The higher the score, better outcomes	pre-operatively and post-operatively at 3 and 6 months
Secondary	Lower extremity functional scale	Questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals. The columns on the scale are summed to get a total score. The maximum score is 80. The higher the score, better outcomes = 80/80 =100%	pre-operatively and post-operatively at 3 and 6 months
Secondary	Sports Medicine Questionnaire	Assess return to activity; no scale, individual questions	pre-operatively and post-operatively at 3 and 6 months
Secondary	Patient satisfaction	0- 100, higher the score, the better	Post-operatively at 3 and 6 months