Clinical trial NCT05088525: Meniscal Root Tears: Evaluation Using an Ultrahigh MRI
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injuries
Keywords: Meniscal Root
MRI
Lead sponsor: Twin Cities Orthopedics
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 27
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: MRI
timeFrame: Pre-operatively
measure: MRI
timeFrame: 6 months post-operatively
Secondary outcomes:
measure: visual analog scale (VAS) scores
timeFrame: pre-operatively and post-operatively at 3 and 6 months
measure: International Knee Documentation Committee (IKDC)
timeFrame: pre-operatively and post-operatively at 3 and 6 months
measure: Cincinnati Knee Rating System
timeFrame: pre-operatively and post-operatively at 3 and 6 months
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: pre-operatively and post-operatively at 3 and 6 months
measure: Tegner
timeFrame: pre-operatively and post-operatively at 3 and 6 months
measure: Lysholm Knee Scoring Scale
timeFrame: pre-operatively and post-operatively at 3 and 6 months
measure: Veterans Rand 12 (VR-12) General Health Survey
timeFrame: pre-operatively and post-operatively at 3 and 6 months
measure: Lower extremity functional scale
timeFrame: pre-operatively and post-operatively at 3 and 6 months
measure: Sports Medicine Questionnaire
timeFrame: pre-operatively and post-operatively at 3 and 6 months
measure: Patient satisfaction
timeFrame: Post-operatively at 3 and 6 months
Other outcomes:
Locations:
city: Edina
country: United States
facility: Twin Cities Orthopedics
state: Minnesota
Study officials:
affiliation: Twin Cities Orthopedics
name: Robert F LaPrade, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: