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Knee InjuriesNCT05088525

Meniscal Root Tears: Evaluation Using an Ultrahigh MRI

A study testing MRI in people with Knee Injuries, run by Twin Cities Orthopedics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 14 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Knee Injuries
What is being tested?
MRI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
20 Nov 2020to 15 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • < 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Twin Cities Orthopedics

    Edina, Minnesota, 55435

Other trials in United States

About this study

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

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.

Read the 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
Being tested
MRI
Keywords
Meniscal Root, MRI
Medical subject headings
Knee Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRIProcedure or surgery

    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.

Study groups in NCT05088525
Study groupRoleWhat they receive
Two-tunnel meniscal root repair without a peripheral stabilization sutureActive comparatorStandard root repair surgery.
Receives: Procedure: MRI
Meniscal root repair with an additional transtibial peripheral stabilization sutureExperimentalMeniscus root repair with an added stabilization suture
Receives: Procedure: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MRI

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

    Measured: Pre-operatively

  2. MRI

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

    Measured: 6 months post-operatively

Secondary outcomes (10)

  1. visual analog scale (VAS) scores

    Pain scale 0-100

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

  2. 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%

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

  3. Cincinnati Knee Rating System

    Functional assessment based on 6 abilities important for participation in sports. The higher the score, better outcomes 100/100 = 100%

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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

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

  8. 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%

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

  9. Sports Medicine Questionnaire

    Assess return to activity; no scale, individual questions

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

  10. Patient satisfaction

    0- 100, higher the score, the better

    Measured: Post-operatively at 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2021
  2. Study start20 Nov 2020
  3. Primary completion15 Nov 2024
  4. Study completion15 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05088525
Sponsor's protocol ID
RFL_UMN-7T MRI
Status last verified
Nov 2024
First submitted
14 Sep 2021
Last updated
22 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40901697

Questions about this trial

What is this clinical trial studying?

A study testing MRI in people with Knee Injuries, run by Twin Cities Orthopedics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRI (time frame: Pre-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05088525, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024; AzTrials last refreshed its copy on 27 Oct 2026.

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