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Operative vs Non-operative Management of Posterior- medial Meniscal Root Tears: A Randomized Multicenter International Trial

Efficacy of Operative vs Non-operative Management of Posterior- medial Meniscal Root Tears: A Randomized Multicenter International Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001556730
Acronym
The ROOT trial
Enrollment
140
Registered
2022-12-16
Start date
2023-01-02
Completion date
2023-12-29
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Medial meniscal root tears are a specific injury to the meniscus which have significant biomechanical implications. There are multiple options for treating these injuries. Some providers treat these injuries without surgery, including physical therapy, reducing the amount of weight you put on the injury leg using either crutches or a brace, and medications that help relieve pain and reduce inflammation. The other option is to treat this injury with surgery, in which the orthopaedic surgeon uses a camera (arthroscope), small tools, and surgical drills to repair the meniscus. The purpose of this study is to compare the results from these two treatment approaches to see if there are any difference in pain, function, and indicators of arthritis and the function of the meniscus that we are able to see on x-rays and magnetic resonance imaging (MRI). Our hypothesis is that medial meniscal root repair will lead to improved outcomes when compared to non-operative treatment.

Interventions

The study intervention is medial meniscal posterior root repair. This procedure will be performed once by an experienced orthopaedic knee surgeon in the operating room of a hospital. This procedure involves repairing the torn posterior root of the medial meniscus with sutures pulled down through a bone tunnel. The procedure takes approximately 45 minutes to one hour.

Sponsors

Rush University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

MRI verified isolated medial meniscal posterior root tear

Exclusion criteria

(1) Concurrent ligamentous knee pathology requiring surgical intervention (i.e. anterior cruciate ligament tear, posterior cruciate ligament tear, posterolateral corner injury, high-grade medial collateral ligament tear), (2) Preoperative Kellgren-Lawrence grade of 3 or 4 (3) Inability to complete outcome questionnaires or comply with required postoperative imaging or MRI requirements, or (4) Medical contraindications to surgery or physical therapy. There will be no exclusion criteria regarding body mass index (BMI) or mechanical alignment, however they will be stratified in groups for further analysis (BMI less and over 35 and varus alignment below and over 3º of varus. (5) Pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026