A Finnish research team led by IDEAL member Teppo Järvinen questions the use of arthroscopic partial meniscectomy – one of the most common surgical procedures in the Western world.
Teppo explains: ” Problems related to degenerative knee disease are commonplace and impose a significant burden on health care systems worldwide. The most common diagnosis of the knee that requires (surgical) treatment is a tear in the meniscus, for which the established form of treatment has been arthroscopic partial meniscectomy (APM). APM has become the most common orthopaedic surgical procedure – and in fact, any surgical procedure next to cataract surgery – in nearly all Western countries. For example, in the United States alone, the annual number of these operations is close to one million. Previous randomised studies have shown that arthroscopic surgery on the knee does not alleviate the symptoms of patients who suffer from osteoarthritis – whether the surgery would be for a meniscal tear or another complaint – and as a result, arthroscopic surgeries on arthritis sufferers have become less common. At the same time, however, the number of APM has increased significantly, even though there is a lack of evidence on the efficacy of the procedure.
The goal of the Finnish Degenerative Meniscal Lesion Study (FIDELITY) trial was to determine whether APM is an effective treatment in patients with symptoms attributed to a degenerative meniscus tear. To obtain the desired efficacy–design (‘proof-of-concept’), a sample of 146 participants with most optimal anticipatable response to index surgery were recruited from five different orthopaedic departments by very experienced surgeons using very stringent eligibility criteria (i.e., age between 35 and 65; no or only mild degenerative changes). The participants were then randomly assigned to undergo either APM or placebo surgery (where a standard diagnostic arthroscopy was first performed, followed by simulated resection). In the simulated resection procedure, the patient’s knee was manipulated and instruments used to carry out APM were brought to the outside of the knee, giving the patient an impression of a normal procedure. No one involved in the study (including the patients, the persons involved in their care after surgery, and the researchers who analysed the results) knew whether the patient was in the APM or placebo group.
A year after the surgery, the patients were asked about the healing of the knee, symptoms they had experienced, as well as their satisfaction with the treatment and its results. The patients were also asked which group they believed they had been in and whether they would be willing to choose the treatment they had received, if they had to make the same decision as they did before surgery. The participants in the two study groups reported virtually identical symptoms on three different outcome instruments and were similarly satisfied with the overall situation of their knee. In both groups, most patients were also satisfied with the status of their knee and believed their knee felt better than before the procedure. Of the patients who underwent the partial meniscectomy, 93% would choose the same treatment, while 96% of those in the placebo group would choose the same”
Teppo concludes: “The results of our randomized, placebo surgery controlled FIDELITY trial show that arthroscopic partial medial meniscectomy provides no additional relief of knee symptoms to placebo surgery in patients with degenerative meniscus tear. Currently millions of people worldwide are being exposed to APM without evidence of benefits while there are risks and substantial costs inherent in surgery. Our study – along with other high-quality evidence available – provides a compelling argument that APM should not be used for the treatment of patients with a degenerative meniscus tear”
Further information: Teppo Järvinen, MD, PhD, University of Helsinki and Helsinki University Central Hospital, Department of Orthopaedics and Traumatology, Helsinki, FINLAND. Tel. +358 400 246 426 Email: firstname.lastname@example.org
The FIDELITY research project includes the Helsinki University Central Hospital, the Kuopio and Turku University Hospitals, the Hatanpää Hospital in Tampere, the Central Finland Central Hospital and the National Institute for Health and Welfare.
References: Raine Sihvonen, M.D., Mika Paavola, M.D., Ph.D., Antti Malmivaara, M.D., Ph.D., Ari Itälä, M.D., Ph.D., Antti Joukainen, M.D., Ph.D., Heikki Nurmi, M.D., Juha Kalske, M.D., and Teppo L.N. Järvinen, M.D., Ph.D. for the Finnish Degenerative Meniscal Lesion Study (FIDELITY) Group. Arthroscopic Partial Meniscectomy versus Sham Surgery for a Degenerative Meniscal Tear. N Engl J Med 2013; 369:2515-2524 (DOI: 10.1056/NEJMoa1305189) http://www.nejm.org/doi/full/10.1056/NEJMoa1305189
For more detailed elaboration of the execution of the FIDELITY trial (and the novel ’RCT within a cohort’-design), see: Raine Sihvonen, Mika Paavola, Antti Malmivaara, Teppo L N Järvinen. Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel ‘RCT within-a-cohort’ study design. BMJ Open 2013;3:e002510 doi:10.1136/bmjopen-2012-002510 http://bmjopen.bmj.com/content/3/3/e002510.full
Comment by IDEAL Steering Group member Philipp Dahm, University of Florida:
“Dr. Järvinen and the members of his research team should be congratulated on their extraordinary study comparing arthroscopic partial medial meniscectomy to sham surgery. This study throws a spotlight on the fact that an invasive and costly surgical procedure is performed millions of times worldwide in the absence of high quality of evidence to prove its putative benefits. It further illustrates that well-done randomized controlled trials of surgical interventions can be performed despite their inherent challenges with regards to equipoise and blinding IF the appropriate commitment exists.
There is clearly a new generation of surgical investigators out there whom I’d encourage to endorse the IDEAL recommendations and pursue similar, practice-changing research.”