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Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03037242
Recruitment Status : Active, not recruiting
First Posted : January 31, 2017
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Diane L. Dahm, Mayo Clinic

Brief Summary:
The results of this study will optimize the care for patients with a meniscus root tear. Surgeons will be able to determine if MRR (meniscus root repair) with transtibial pullout technique is an effective treatment and will identify potential risk factors for poor clinical outcomes. In addition, investigators will determine if MRR is successful in delaying the radiographic progression of arthritis in the involved compartment.

Condition or disease Intervention/treatment Phase
Meniscus Tear Procedure: Transtibial pullout technique Not Applicable

Detailed Description:

The loss of attachment at the root of the meniscus impairs the ability to maintain hoop strain when the tibiofemoral joint is loaded. This loss of hoop strain is responsible for the increased pressure on the articular cartilage.

This new awareness has prompted surgeons to consider surgical repair for treatment of meniscal root avulsions. Despite this recent focus on results of surgical repair, prospective studies are lacking, and the optimal surgical indications and technique have not been optimized.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Center Prospective Clinical and Radiographic Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Transtibial pullout technique
Evaluation of the clinical and radiographic outcomes for patients undergoing a meniscus root repair (MRR) using a transtibial pullout technique.
Procedure: Transtibial pullout technique
Evaluating radographs




Primary Outcome Measures :
  1. Change in Tegner activity score [ Time Frame: baseline, 2 years ]

    Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. The score varies from 0-10.

    A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports >6 score can only be achieved if the person participates in recreational or competitive sport.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meniscus root avulsion tear (defined as meniscus posterior horn root avulsion or full thickness tear within 9 mm of the root attachment)
  2. Age 18-65
  3. Ligament injury with concomitant reconstruction is acceptable
  4. Malalignment with corrective osteotomy is acceptable

Exclusion Criteria:

  1. Subchondral collapse on pre-op MRI
  2. Extrusion greater than 3 mm
  3. Intra-op Outerbridge grade 3 or greater chondromalacia
  4. Intra-op poor quality meniscus tissue
  5. Mal-alignment greater than 5 degrees without corrective osteotomy
  6. Obesity with BMI over 40
  7. Kellgren Lawrence > grade 2
  8. Worker's compensation status

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037242


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Columbia Orthopaedic Group
Columbia, Missouri, United States, 65201
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Diane Dahm, M.D. Mayo Clinic

Additional Information:
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Responsible Party: Diane L. Dahm, Professor of Orthopedics, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03037242     History of Changes
Other Study ID Numbers: 16-005841
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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