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Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

140 Participants Needed

Surgery vs Pain Management for Torn Meniscus

Overseen ByJorge Chahla, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Concurrent knee pathology, Pregnancy, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine differences in pain, functional patient reported outcomes, and objective imaging parameters following non-operative and meniscus root repair treatment. Furthermore, the long-term goal of this research proposal is to understand the natural history of meniscal root tears and their subsequent repair, in order to better determine risk factors for inferior outcomes and progression to osteoarthritis (OA).

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for meniscal root tears?

Research shows that repairing meniscal root tears through surgery can restore normal knee joint mechanics and delay the onset of arthritis. Short- and midterm results of surgical repair are promising, but long-term outcomes are still being studied.¹ ² ³ ⁴ ⁵

Is surgery for a torn meniscus generally safe?

Surgical repair of meniscal root tears is considered safe and can restore normal knee function, but long-term safety data is still being studied. Short- and midterm results are promising, and the technique aims to avoid additional injuries to the knee.¹ ⁴ ⁵ ⁶ ⁷

How is the treatment for meniscal root tears different from other treatments?

The treatment for meniscal root tears, known as meniscus root repair, is unique because it aims to restore normal joint mechanics and delay the development of osteoarthritis by repairing the meniscal root, which is crucial for proper load distribution in the knee. Unlike other treatments that may focus solely on pain management, this surgical approach addresses the underlying biomechanical issues to prevent further joint damage.¹ ² ³ ⁴ ⁵

Research Team

Jorge Chahla, MD

Principal Investigator

Rush University Medical Center Associate Professor and Surgeon

Eligibility Criteria

This trial is for adults with an MRI-confirmed isolated tear in the medial meniscus root of the knee. Candidates must be able to complete questionnaires and undergo post-treatment imaging. People with additional serious knee injuries, advanced osteoarthritis, or conditions that make surgery or physical therapy risky cannot participate.

Inclusion Criteria

My MRI shows I have a specific knee injury to the inner meniscus.

I am 18 years old or older.

Exclusion Criteria

I need surgery for a serious knee ligament injury.

I am under 18 years old.

My knee arthritis is severe.

See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either non-operative management with analgesics and physical therapy or operative intervention with transtibial medial meniscus root repair

6 weeks

Weekly physical therapy sessions for non-operative group

Crossover Evaluation

Participants in the non-operative group are evaluated for symptomatic improvement and may crossover to the operative group if no improvement is seen

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment with patient-reported outcomes, radiographs, and MRI

12 months

Treatment Details

Interventions

Non-Operative Pain Management
Operative Treatment

Trial OverviewThe study compares two approaches for treating a torn meniscus: surgical repair within three weeks of joining the trial versus non-operative pain management. The goal is to assess differences in pain relief, functional outcomes reported by patients, and changes seen on imaging over time.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Operative Intervention (ARM 2)Experimental Treatment1 Intervention

Subjects randomized to the operative treatment arm will undergo transtibial medial meniscus root repair within 3 weeks of enrollment. All surgically treated subjects, regardless if repairs were performed acutely or after cross over, will receive identical postoperative rehabilitation.

Group II: Non-operative Control (ARM 1)Active Control1 Intervention

Subjects randomized to the non-operative treatment arm will receive analgesics, physical therapy and will remain non-weight bearing. This will consist in anti-inflammatory drugs daily for 8-12 weeks and supervised physical therapy at least twice a week over a period of 8 weeks. Subjects in the non-operative arm will be offered the opportunity to crossover to the operative arm (ARM 2) of the study if the subjects do not report symptomatic improvement within 3 months after entry in this study.

Operative Treatment is already approved in United States, European Union for the following indications:

Approved in United States as Meniscus Root Repair for:

Posterior-medial meniscal root tears

Approved in European Union as Meniscus Root Repair for:

Meniscal root tears
Knee instability

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS)

Collaborator

Trials

Recruited

140+

Findings from Research

Meniscal repair for root tears is associated with the lowest risk of needing total knee arthroplasty (TKA), with rates as low as 0% to 1%, compared to 11% to 54% for partial meniscectomy and 31% to 35% for conservative treatment.

Patients undergoing meniscal repair showed the greatest functional improvement and slower progression of knee degeneration, indicating it is a more effective treatment option than both partial meniscectomy and conservative methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Outcomes of Meniscal Root Tears: A Systematic Review.Stein, JM., Yayac, M., Conte, EJ., et al.[2022]

In a review of six randomized controlled trials involving 796 patients with meniscus injuries, no significant differences in pain relief were found among various treatment methods, including surgery and exercise, over both short-term (3 months) and mid-term (12 months) periods.

However, the combination of supervised exercise and surgery was ranked as the most effective approach for reducing pain in both the short-term and mid-term, suggesting it may be the best option among the treatments evaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effects on pain arising from injury to the knee meniscus in adults: A systematic review and network meta-analysis.Zhang, Y., Cao, W., Cao, Q., et al.[2022]

Meniscal root tears are increasingly recognized as significant injuries that require careful consideration for surgical repair, highlighting the need for tailored treatment approaches.

Differences in clinical outcomes between medial and lateral meniscal root tears may be influenced by unique anatomical factors and the specific demographics of the patients who sustain these injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Comparing Medial and Lateral Meniscal Root Tears Is Like Comparing Apples and Oranges.LaPrade, RF., DePhillipo, NN., Larson, CM.[2020]