Why was this trial needed?
Meniscal damage in MRI imaging is a common finding in middle-aged and older patients with knee pain. Conventional wisdom dictates that these ‘meniscal tears’ are the origin for knee pain. Following this rationale, arthroscopic partial meniscectomy (APM) to trim the lesions became the most common orthopedic procedure with approximately two million such procedures each year. Remarkably, there was no convincing evidence to justify the practice.
A series of randomized controlled trials, including the FIDELITY, established that APM has minimal or no beneficial effects on patients’ symptoms. High prevalence of knee osteoarthritis (OA) among patients having undergone APM prompted concerns about APM potentially accelerating the progression of knee degeneration.
What is the primary objective of the FIDELITY trial?
In the original FIDELITY trial, we showed that APM was not any better than placebo surgery in relieving knee pain and other symptoms in patients with a degenerative meniscus tear in short-term (1- and 2-year follow-up).
The objective of our 5- and 10-year follow-up extensions, the FIDELITY-OA, is to determine the possible effect of APM on the knee symptoms and development of knee OA.
Where are we now?
We have already published the following articles:
- Protocol article in the BMJ Open
- 1-year results in the New England Journal of Medicine
- 2-year results in the Annals of the Rheumatic Diseases
- A report on the effect of APM on mechanical symptoms in the Annals of Internal Medicine.
The 5-year follow-up examinations are completed and we are working with the data!