351 Participants Needed

Knee Surgery vs Physical Therapy for Osteoarthritis

Recruiting at 6 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

There are two cartilage structures, called menisci, in each knee joint. A torn meniscus can be caused by a traumatic injury or aging-related degeneration. Osteoarthritis (OA) is a type of arthritis that is caused by the breakdown and eventual loss of another type of cartilage that covers the end of bones within a joint. In people who have knee OA, a meniscal tear can easily lead to disability. This study will compare the effectiveness of two recommended treatments, surgery and physical therapy, for people with a torn meniscus and knee OA.

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

The trial protocol does not specify whether you need to stop taking your current medications. It seems that managing OA symptoms with medications is part of the inclusion criteria, so you may be able to continue them.

Is knee surgery or physical therapy safe for treating osteoarthritis?

Both knee surgery (arthroscopic partial meniscectomy) and physical therapy have been studied for safety in humans. The METEOR trial found that physical therapy is a safe initial treatment for knee issues related to osteoarthritis, and delaying surgery does not harm long-term outcomes. No major safety concerns were highlighted in the studies reviewed.12345

How does knee surgery differ from physical therapy for osteoarthritis?

Arthroscopic partial meniscectomy is a surgical procedure that involves removing damaged parts of the meniscus in the knee, which can provide immediate relief from pain and improve joint function. In contrast, standard physical therapy focuses on exercises and techniques to strengthen muscles around the knee, improve flexibility, and reduce pain over time without surgery.678910

What data supports the effectiveness of the treatment for knee osteoarthritis?

Research suggests that physical therapy can be an effective initial treatment for knee osteoarthritis with a torn meniscus, as surgery is not always necessary and delaying it does not worsen outcomes. Additionally, patients with certain types of meniscal tears may benefit from physical therapy over surgery.1341112

Who Is on the Research Team?

JN

Jeffrey N Katz, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for people with a specific knee problem where the cushioning cartilage (meniscus) is torn and they also have osteoarthritis. They must have had symptoms for at least a month, tried some treatments like meds or physical therapy, and be okay with being randomly assigned to treatment groups. People can't join if they've had previous knee surgery on the affected leg, are pregnant, have certain other joint diseases or severe arthritis needing total knee replacement.

Inclusion Criteria

Evidence of a meniscal tear (tear extending to surface of meniscus) on a knee MRI
I experience symptoms like clicking, pain, or instability in my knee, suggesting a torn meniscus.
Available knee X-ray (within 6 months) and MRI (within 3 years)
See 3 more

Exclusion Criteria

Pregnancy or possible pregnancy
I have no health issues preventing surgery or physical therapy.
My knee arthritis is severe, possibly needing a knee replacement.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants are randomly assigned to either undergo APM surgery followed by physical therapy or receive standard physical therapy for 8 weeks

8 weeks
1-3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with regular visits and questionnaires

12 years
5 visits (in-person) at 3 months, 18 months, 5 years, and 12 years; regular phone calls and mailed questionnaires

What Are the Treatments Tested in This Trial?

Interventions

  • Arthroscopic partial menisectomy
  • Postoperative rehabilitative physical therapy
  • Standard physical therapy
Trial Overview The study compares two common treatments for meniscal tears in patients with osteoarthritis: one group will undergo arthroscopic partial meniscectomy followed by rehab physical therapy; another group will receive standard physical therapy without surgery. The goal is to see which approach helps more.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: SurgicalExperimental Treatment2 Interventions
Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.
Group II: NonoperativeActive Control1 Intervention
Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Published Research Related to This Trial

In a study involving 515 patients with hormone-sensitive prostate cancer, those receiving abiraterone acetate plus prednisone (AAP) alongside standard care reported a higher quality of life (QOL) compared to those receiving docetaxel plus standard care, with a mean difference of +3.9 points over two years.
The improvement in global-QOL scores for the AAP group was particularly significant during the first year, with increases of +5.7 points at one year and +8.3 points at two years, indicating that AAP may offer better patient-reported outcomes in terms of quality of life.
Quality of Life in Men With Prostate Cancer Randomly Allocated to Receive Docetaxel or Abiraterone in the STAMPEDE Trial.Rush, HL., Murphy, L., Morgans, AK., et al.[2023]
The addition of abiraterone plus prednisone to androgen deprivation therapy (ADT) has shown substantial survival benefits in patients with metastatic hormone-sensitive prostate cancer (mHSPC), similar to the benefits seen with docetaxel plus ADT, as demonstrated in recent clinical trials.
Current management strategies for mHSPC are evolving, with both abiraterone/prednisone and docetaxel/ADT being considered standard-of-care options, highlighting the need for ongoing research to determine the best initial treatment approach.
The evolving landscape of metastatic hormone-sensitive prostate cancer: a critical review of the evidence for adding docetaxel or abiraterone to androgen deprivation.McNamara, M., Sweeney, C., Antonarakis, ES., et al.[2018]

Citations

The METEOR trial: no rush to repair a torn meniscus. [2022]
Physical therapy after arthroscopic partial meniscectomy: is it effective? [2019]
Functional Outcomes of Arthroscopic Partial Meniscectomy Versus Physical Therapy for Degenerative Meniscal Tears Using a Patient-Specific Score: A Randomized Controlled Trial. [2022]
Arthroscopic partial meniscectomy versus physical therapy for traumatic meniscal tears in a young study population: a randomised controlled trial. [2022]
PURLs: When can exercise supplant surgery for degenerative meniscal tears? [2018]
Effectiveness of supervised physical therapy in the early period after arthroscopic partial meniscectomy. [2016]
No evidence in support of arthroscopic partial meniscectomy in adults with degenerative and nonobstructive meniscal symptoms: a level I evidence-based systematic review. [2023]
Treatment of the Primary Tumor in Metastatic Hormone-sensitive Prostate Cancer: Not Yet Ready for Prime Time as the Standard of Care. [2020]
Adjuvant and neoadjuvant treatment of resectable, locally advanced, rectal carcinoma with radiation therapy and chemotherapy. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Quality of Life in Men With Prostate Cancer Randomly Allocated to Receive Docetaxel or Abiraterone in the STAMPEDE Trial. [2023]
Addition of abiraterone, docetaxel, bisphosphonate, celecoxib or combinations to androgen-deprivation therapy (ADT) for metastatic hormone-sensitive prostate cancer (mHSPC): a network meta-analysis. [2019]
The evolving landscape of metastatic hormone-sensitive prostate cancer: a critical review of the evidence for adding docetaxel or abiraterone to androgen deprivation. [2018]
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