Surgery vs Pain Management for Torn Meniscus

Overseen By Jorge Chahla, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Concurrent knee pathology, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares surgery to pain management for individuals with a torn meniscus, a knee cartilage injury. The researchers aim to determine which treatment provides better pain relief and knee function, and to explore how a torn meniscus might lead to arthritis over time. Participants will either receive pain medication and physical therapy (non-operative pain management) or undergo meniscus surgery (operative treatment). The trial is open to those with a confirmed meniscus tear on an MRI who have been experiencing knee pain. As an unphased trial, it offers a unique opportunity to contribute to understanding effective treatments for knee injuries.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that surgically repairing a torn meniscus root is generally safe and often improves the condition compared to its state before surgery. Studies have found that patients usually experience less pain and better knee movement afterward. However, some risks exist. For instance, one study found that about 20% of these surgeries might not work as expected, whether it's the first surgery or a repeat one.

Possible side effects include pain, swelling, or stiffness after surgery, but these are usually temporary. In the long run, results are often positive, with many patients not needing extra knee support or further treatment.

In summary, while all surgeries carry some risk, current evidence suggests that meniscus root repair is generally well-tolerated and can greatly improve knee health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new approach to treating a torn meniscus because it directly compares surgery with a comprehensive non-operative regimen. Unlike the standard treatment options like arthroscopic surgery or physical therapy alone, this trial examines the potential for pain management and physical therapy combined with a strict non-weight-bearing protocol. This approach could provide a less invasive alternative to surgery while still offering significant relief, especially for patients eager to avoid surgical intervention. Additionally, the possibility for patients to switch to surgery if they see no improvement within three months adds a safety net, ensuring they aren't left without options.

What evidence suggests that this trial's treatments could be effective for a torn meniscus?

This trial will compare surgery with non-surgical pain management for torn meniscus. Research has shown that surgery for meniscus root tears often proves more effective than non-surgical treatments. Studies have found that surgery can lead to better outcomes, such as less narrowing of the knee joint space and improved knee function. Patients who undergo surgery typically feel better two years afterward, experiencing less pain and increased movement. One study found that surgery can lead to long-term improvements without the need for knee braces or frequent follow-up visits. Although there might be a higher chance of needing another operation later, current evidence strongly supports the benefits of surgery for meniscus root tears. ^{2 4 6 7 8}

Who Is on the Research Team?

Jorge Chahla, MD

Principal Investigator

Rush University Medical Center Associate Professor and Surgeon

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I need surgery for a serious knee ligament injury.

I am under 18 years old.

My knee arthritis is severe.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Non-Operative Pain Management
• Operative Treatment

Trial Overview

The 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.

How Is the Trial Designed?

Group I: Operative Intervention (ARM 2) Experimental Treatment 1 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 Control 1 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

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

1

Recruited

140+

Published Research Related to This Trial

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]

Meniscal root injuries significantly affect knee joint mechanics, which can lead to arthrosis, highlighting the importance of maintaining meniscal integrity for proper load distribution.

Arthroscopic meniscal root repair has shown promising short- and midterm clinical results in restoring joint mechanics, although long-term outcomes are still unknown.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meniscal Root Tears Evaluation and Management. Day, MS., Ryan, MK., Strauss, EJ.[2018]

Meniscal root tears, which are serious injuries located near the meniscal attachment, can lead to significant joint issues similar to having the entire meniscus removed, increasing the risk of early osteoarthritis.

Surgical repair of these tears is effective in improving patient outcomes, reducing meniscal extrusion, and slowing down degenerative changes, especially in patients without advanced osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meniscal Root Tears: Current Concepts Review. Pache, S., Aman, ZS., Kennedy, M., et al.[2020]

The newly developed suturing technique for medial meniscal root repair utilizes a tibial tunnel for a pullout suture, which simplifies the repair process and enhances the biomechanics of the knee joint.

This technique minimizes the risk of damaging the articular cartilage during surgery and provides an additional working portal, potentially improving surgical outcomes for patients with meniscal root tears.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Medial Meniscal Root Pullout Repair With the Use of a Tibial Tunnel Suturing Technique. Apivatgaroon, A., Chernchujit, B.[2020]

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 can severely impact knee function, mimicking the effects of a total meniscectomy and leading to early osteoarthritis, highlighting the importance of timely diagnosis and treatment.

Arthroscopic surgical techniques for repairing meniscal root tears have become the preferred method for treating knees with nonadvanced osteoarthritis, aiming to restore joint function and delay degenerative changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meniscal Root Tears: An Update Focused on Preoperative and Postoperative MRI Findings. Guimarães, JB., Chemin, RN., Araujo, FF., et al.[2023]

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]

Citations

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Current evidence suggests root repair may be the most effective treatment strategy in lessening joint space narrowing of the knee and producing improvements in ...

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Long-term outcomes of meniscal root repair tend to be good, not requiring knee bracing or follow-up care. Patients with stage 4 osteoarthritis ...

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