Placebo-surgery controlled trials

High-quality, trustworthy evidence on established clinical practices is obviously essential, but not enough: one needs to make a conscious effort to ensure that the research has practical impact –eliciting a change in the way medicine is practiced around the world!

FIDELITY was considered the key evidence by the Council for Choices in Health Care in Finland (COHERE, a permanent body appointed by the Government that works in conjunction with the Ministry of Social Affairs and Health) in making a rare restrictive funding decision; COHERE declared in 2017 that knee arthroscopy for degenerative knee disease will no longer be included in the range of public health services available in Finland ¹.

Possibly even more noteworthy, in the same year, the BMJ RapidRec panel issued a guideline that made a strong recommendation against the use of arthroscopy in nearly all patients with degenerative knee disease ². The panel went further to recommend that healthcare administrators and funders may use the number of arthroscopies performed in patients with degenerative knee disease as an indicator of poor quality care. It is possible that knee arthroscopy could be considered one of the starkest examples of modern medical reversal.

We just published the FIMPACT trial, so it is too early to say anything about its’ practical impact, but stay tuned, in 2-3 years, we should be able to comment on that, too.

Where are we now?
The funders seem to be reacting to the mounting evidence on various procedures being shown to be marginally effective or “low value care”. Subacromial decompression and knee arthroscopies for arthritis are among an initial list of 17 operations that will be discontinued completely or highly restricted by NHS England:

https://www.bbc.com/news/health-44665560

https://www.theguardian.com/society/2018/jun/29/nhs-wields-the-axe-on-17-unnecessary-procedures

One way to consider this is that in less than 50 years, the use of arthroscopic surgery for knee and shoulder pain went from new techniques to widespread clinical practices, to be utterly rejected. As such, they would mark one of the most staggering examples of Scott’s parabola ³ in medicine (below):

1. A statement on knee arthroscopy for degenerative knee disease by the Council for Choices in Health Care in Finland, Government appointed council working in conjunction with the Finnish Ministry of Social Affairs and Health. http://palveluvalikoima.fi/en/recommendations (accessed May 25, 2017).
2. Siemieniuk RAC, Harris IA, Agoritsas T, et al. Arthroscopic surgery for degenerative knee arthritis and meniscal tears: a clinical practice guideline. Bmj 2017;357:j1982. doi: 10.1136/bmj.j1982
3. Scott JW. Scott’s parabola: the rise and fall of a surgical technique. British Med J 2001;323(1477) doi: 10.1136/bmj.323.7327.1477

Principal investigators

Teppo Järvinen

Professor, Head

Placebo-surgery controlled trials

Principal investigators

Teppo Järvinen

Simo Taimela

News

Let’s get ready to rumble… FIDELITY SAP published!

FICEBO @ the Annual meeting of the Finnish Orthopaedic Association 2019

BMJ Rapid Recommendation: Strong against shoulder decompression surgery

Publications

Statistical Analysis Plan for the 5-year and 10-year Follow-Up Assessments of the FIDELITY Trial

Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo surgery controlled clinical trial

Arthroscopic partial meniscectomy versus placebo surgery for a degenerative meniscus tear: a 2-year follow-up of the randomised controlled trial.

Finnish Subacromial Impingement Arthroscopy Controlled Trial (FIMPACT): a protocol for a randomised trial comparing arthroscopic subacromial decompression and diagnostic arthroscopy (placebo control), with an exercise therapy control, in the treatment of shoulder impingement syndrome.

Mechanical Symptoms and Arthroscopic Partial Meniscectomy in Patients With Degenerative Meniscus Tear: A Secondary Analysis of a Randomized Trial.

A multi-centre randomized controlled trial comparing arthroscopic osteochondroplasty and lavage with arthroscopic lavage alone on patient important outcomes and quality of life in the treatment of young adult (18-50) femoroacetabular impingement.

Arthroscopy for degenerative knee--a difficult habit to break?

Blinded interpretation of study results can feasibly and effectively diminish interpretation bias.

Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear.

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.

Validation of the Western Ontario Meniscal Evaluation Tool (WOMET) for patients with a degenerative meniscal tear: a meniscal pathology-specific quality-of-life index.