Knee Surgery vs Physical Therapy for Osteoarthritis

Not currently recruiting at 7 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?

This trial aims to determine whether surgery or physical therapy is more effective for individuals with knee osteoarthritis (OA) and a torn meniscus. The trial will compare arthroscopic partial meniscectomy (a type of knee surgery) with standard physical therapy sessions. Individuals who have experienced OA symptoms for at least a month and have issues like knee pain, popping, or clicking may be suitable candidates. Participants should have recent knee X-rays or MRIs showing a meniscal tear. The goal is to identify which treatment improves knee function and reduces pain. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance treatment options for knee OA and meniscal tears.

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

Research has shown that arthroscopic partial meniscectomy (APM), a type of knee surgery, is usually well-tolerated, though some risks exist. One study found that only four out of 100 patients experienced poor results after the surgery. However, APM might slightly increase the risk of developing knee arthritis. Patients with meniscal tears in an already arthritic knee who underwent APM were nearly five times more likely to require additional surgery, such as a total knee replacement, compared to those who did not have the surgery.

While no specific studies on physical therapy are mentioned here, standard physical therapy is generally considered safe and is commonly used for knee problems. It typically includes exercises to strengthen and stretch the knee over several weeks.

In summary, APM carries some risks, such as the potential for increased arthritis or the need for further surgery, but many patients do well. Physical therapy remains a common and safe alternative for managing knee issues.12345

Why are researchers excited about this trial?

Most treatments for knee osteoarthritis, like pain medications and lifestyle changes, focus on managing symptoms rather than directly addressing the knee structure. Researchers are excited about comparing knee surgery and physical therapy because these approaches tackle the problem differently. Arthroscopic partial meniscectomy (APM) surgery aims to directly repair the knee's internal structure, potentially offering longer-term relief by fixing the underlying issue. Meanwhile, standard physical therapy strengthens and stretches the knee, enhancing mobility and reducing pain without surgery. This trial could provide critical insights into which approach more effectively improves patients' quality of life.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

This trial will compare arthroscopic partial meniscectomy (APM) surgery with standard physical therapy for knee osteoarthritis. Research has shown that APM surgery often provides good short-term relief for knee pain, with most patients reporting significant improvements in pain and symptoms after one year. However, a small risk of developing knee osteoarthritis, a joint disease, exists after the surgery. In contrast, physical therapy, which participants in this trial may receive, also improves knee function and pain, though it might not be as effective in the long term compared to surgery. Both treatments are effective, with surgery offering quicker relief, while physical therapy remains a non-invasive option.12467

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
Available knee X-ray (within 6 months) and MRI (within 3 years)
I experience symptoms like clicking, pain, or instability in my knee, suggesting a torn meniscus.
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
Group II: NonoperativeActive Control1 Intervention

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

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]
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]

Citations

Meniscectomy is associated with a higher rate of osteoarthritis ...Meniscal repair is associated with a lower progression to knee osteoarthritis at approximately six years of follow-up compared to partial meniscectomy.
Arthroscopic Partial Meniscectomy in Patients With ...At the 1-year follow-up, most patients achieved MCID: 73% in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain, 66% in KOOS Symptoms, and 78% in KOOS ...
Effect of Physical Therapy vs Arthroscopic Partial ...From baseline to 5-year follow-up, the mean (SD) improvement was 29.6 (18.7) points in the surgery group and 25.1 (17.8) points in the physical ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36646304/
Arthroscopic partial meniscectomy vs non-surgical or sham ...Results: The APM group showed a small improvement over the non-surgical or sham group on knee pain at 24 months follow-up (2.5 points (95% CI: ...
Arthroscopic partial meniscectomy for a degenerative ...APM was associated with a slightly increased risk of developing radiographic knee osteoarthritis and no concomitant benefit in patient-relevant outcomes, at 5 ...
On Patient Safety: Orthopaedic Surgeons Must Stop ...Those authors found that patients treated with knee arthroscopy for meniscal tears in an arthritic joint were almost five times more likely to proceed to total ...
Clinical outcomes of arthroscopic partial meniscectomy at ...The subjective assessment after surgery in our study indicated that only four patients out of 100 had poor results, whereas the remaining 96 ...
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