Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique

Meniscus Tear Clinical Trial

Official title:

Multi-Center Prospective Clinical and Radiographic Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03037242
• Other study ID #: 16-005841
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 55
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Meniscus Tear

Intervention

Procedure:
• Transtibial pullout technique
Evaluating radographs

Locations

Country	Name	City	State
United States	Columbia Orthopaedic Group	Columbia	Missouri
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Tegner activity score	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.	baseline, 2 years