Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique

• Sponsor: Mayo Clinic (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT03037242
• Collaborator: (none)
• Enrollment: 55
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 91
• Patients Per Site: 27.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 55 participants
• Allocation: N/A
• 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
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Outcome Measures

Primary Outcome Measures

1. Change in Tegner activity score [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905
2	Columbia Orthopaedic Group	Columbia	Missouri	United States	65201

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Daniel Saris, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Daniel B. F. Saris, Professor of Orthopedics, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03037242
• Other Study ID Numbers: 16-005841
• First Posted: Jan 31, 2017
• Last Update Posted: Jan 11, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 11, 2022