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Meniscal Root Tears: Evaluation Using an Ultrahigh MRI

Primary Purpose

Knee Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
Twin Cities Orthopedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injuries focused on measuring Meniscal Root, MRI

Eligibility Criteria

14 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Twin Cities OrthopedicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Two-tunnel meniscal root repair without a peripheral stabilization suture

Meniscal root repair with an additional transtibial peripheral stabilization suture

Arm Description

Standard root repair surgery.

Meniscus root repair with an added stabilization suture

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

visual analog scale (VAS) scores
Pain scale 0-100
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%
Cincinnati Knee Rating System
Functional assessment based on 6 abilities important for participation in sports. The higher the score, better outcomes 100/100 = 100%
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.
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.
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.
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
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%
Sports Medicine Questionnaire
Assess return to activity; no scale, individual questions
Patient satisfaction
0- 100, higher the score, the better

Full Information

First Posted
September 14, 2021
Last Updated
April 12, 2023
Sponsor
Twin Cities Orthopedics
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1. Study Identification

Unique Protocol Identification Number
NCT05088525
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Twin Cities Orthopedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
Meniscal Root, MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Two-tunnel meniscal root repair without a peripheral stabilization suture
Arm Type
Active Comparator
Arm Description
Standard root repair surgery.
Arm Title
Meniscal root repair with an additional transtibial peripheral stabilization suture
Arm Type
Experimental
Arm Description
Meniscus root repair with an added stabilization suture
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
MRI
Description
Musculoskeletal radiologist assessment of medial meniscus extrusion and cartilage specific sequences gathered
Time Frame
Pre-operatively
Title
MRI
Description
Musculoskeletal radiologist assessment of medial meniscus extrusion and cartilage specific sequences gathered
Time Frame
6 months post-operatively
Secondary Outcome Measure Information:
Title
visual analog scale (VAS) scores
Description
Pain scale 0-100
Time Frame
pre-operatively and post-operatively at 3 and 6 months
Title
International Knee Documentation Committee (IKDC)
Description
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%
Time Frame
pre-operatively and post-operatively at 3 and 6 months
Title
Cincinnati Knee Rating System
Description
Functional assessment based on 6 abilities important for participation in sports. The higher the score, better outcomes 100/100 = 100%
Time Frame
pre-operatively and post-operatively at 3 and 6 months
Title
Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
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.
Time Frame
pre-operatively and post-operatively at 3 and 6 months
Title
Tegner
Description
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.
Time Frame
pre-operatively and post-operatively at 3 and 6 months
Title
Lysholm Knee Scoring Scale
Description
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.
Time Frame
pre-operatively and post-operatively at 3 and 6 months
Title
Veterans Rand 12 (VR-12) General Health Survey
Description
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
Time Frame
pre-operatively and post-operatively at 3 and 6 months
Title
Lower extremity functional scale
Description
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%
Time Frame
pre-operatively and post-operatively at 3 and 6 months
Title
Sports Medicine Questionnaire
Description
Assess return to activity; no scale, individual questions
Time Frame
pre-operatively and post-operatively at 3 and 6 months
Title
Patient satisfaction
Description
0- 100, higher the score, the better
Time Frame
Post-operatively at 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Becky Stone
Phone
952-456-7136
Email
research@tcomn.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kayla Seiffert
Phone
952-456-7085
Email
research@tcomn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert F LaPrade, MD, PhD
Organizational Affiliation
Twin Cities Orthopedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Twin Cities Orthopedics
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Becky Stone
Phone
952-456-7136
Email
research@tcomn.com
First Name & Middle Initial & Last Name & Degree
Robert F LaPrade, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Meniscal Root Tears: Evaluation Using an Ultrahigh MRI

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