The evidence base for orthopaedics and sports medicine
BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.g7835 (Published 02 January 2015) Cite this as: BMJ 2015;350:g7835
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We thank Mr. Chitnavis for his interest and response, and wish to correct some apparent misconceptions of published results.
At least 9 published randomised controlled trials have compared the benefit of arthroscopic meniscal surgery with non-surgical management or sham surgery. The most recent systematic review and meta-analysis concludes “there is no benefit to arthroscopic meniscal débridement for degenerative meniscal tears in comparison with nonoperative or sham treatments in middle-aged patients with mild or no concomitant osteoarthritis”.(1) It seems difficult to justify invasive surgery simply to obtain an effect similar to the placebo effect of sham surgery, or with no additional effect over that of a non-surgical treatment with lower cost and risk of harms.
The common interpretation of observational uncontrolled studies, that delayed compared to early anterior cruciate ligament reconstruction results in a higher frequency of meniscus injuries, is confounded by indication. In our prospective randomised controlled trial, we found no statistically significant difference between treatments in the number of knees having meniscus surgery over the first two or five years after anterior cruciate ligament injury, either for the full analysis set or between the ‘as treated’ groups.(2,3) Our five year prospective trial showed that in young, active adults with an acute anterior cruciate ligament tear, a strategy of early reconstruction plus rehabilitation did not provide better results, whether measured as patient reported outcomes, radiographic osteoarthritis, or meniscus surgery, than a strategy of initial rehabilitation with the option of having a later anterior cruciate ligament reconstruction. Using the second strategy, 50% of the patients did not need a reconstruction. We did not find evidence of one treatment being more harmful than the other.(3)
Impressions can indeed be deceiving, not only in medicine. When high level evidence goes counter to clinical experience and impressions, cognitive dissonance results.(4,5) Defenders of questioned treatments focus on potential flaws in the published trials to invalidate trial results, while ignoring the inherent biases of clinical experience.
A culture of best everyday practice based on systematically collected evidence and shared decision making does not exclude sound clinical judgment, it relies on it.
(1) Khan M, Evaniew N, Bedi A, Ayeni OR, Bhandari M. Arthroscopic surgery for degenerative tears of the meniscus: a systematic review and meta-analysis. CMAJ 2015; in press. Published at www.cmaj.ca on August 25, 2014.
(2) Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tear. New Engl J Med 2010;363:331-42.
(3) Frobell RB, Roos HP, Roos EM, Roemer FW, Ranstam J, Lohmander LS. The five year outcome of a randomized trial for acute anterior cruciate ligament tear. BMJ 2013;346:f232.
(4) Miller FG, Kallmes DF. The case of vertebroplasty trials. Promoting a culture of evidence-based procedural medicine. Spine2010;35:2023-6.
(5) Lohmander LS, Roos EM. The evidence base for orthopaedics and sports medicine. Scandalously poor in parts. BMJ 2015;350:g7835.
Competing interests: No competing interests
Orthopaedic surgeons and their patients will be disturbed to read that operations such as arthroscopic meniscal surgery and anterior cruciate ligament (ACL) reconstruction are of no proven benefit. (1)
In support of their argument, Lohmander and Roos present two studies published in the New England Journal of Medicine. (2, 3) These randomised controlled trials have been critically reviewed and their limitations highlighted. For example, from a cohort of patients avoiding ACL reconstruction, 39% defaulted and underwent surgery within only two years of incident injury. (4) And those deferring ACL reconstruction were also significantly more likely to need menisectomy over that period. (5)
Knee surgery is rarely mandatory for soft-tissue injury. Neither life nor limb is saved. The joint has evolved over millennia to survive trauma, albeit at the cost of the pain and dysfunction. Clinicians and patients have learned the hard way. Those returning to pivoting sport with unstable knees have a high risk of developing further meniscal injury, chondral damage and arthritis.(6)
In their article, Lohmander and Roos state that ‘clinical impressions can be deceiving’.
I believe it is good surgical practice to ask patients directly about outcome. ‘Was the operation worth it’?
Most usually say: ‘Yes doctor, my knee doesn’t hurt any more’ or ‘Yes, thanks, my knee is stable now’.
But the strongest endorsement for any surgeon is a patient returning with a symmetrical problem in the opposite knee, clearly satisfied with previous surgery. Such scenarios are common, often years after the first operation.
In an era obsessed with evidence-based practice, whose clinical impressions matter most, the doctor’s or the patient’s?
Jai Chitnavis MA MChir FRCS
Consultant Orthopaedic Surgeon
Cambridge, UK.
1. L Stefan Lohmander, Ewa M Roos. The evidence base for orthopaedics and sports medicine. Scandalously poor in parts. BMJ 2015;350:g7835.
2. Sihvonen R, Paavola M, Malmivaara A et al. Arthroscopic partial menisectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med 2013;369:2515-2524.
3. Frobell RB, Roos EM, Roos HP, Ranstram J, Lohmader LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med 2010;363:331-342.
4. Levy BA. Is early reconstruction necessary for all anterior cruciate ligament tears? N Engl J Med 2010;363;386-388.
5. Richmond JC, Lubowitz JH, Poehling GG. Prompt operative intervention reduces long-term osteoarthritis after knee anterior cruciate ligament tear. Arthroscopy 2011 Feb;27(2):149-152.
6. Sri-Ram K, Salmon LJ, Pinczewski LA, Roe JP. The incidence of secondary pathology after anterior cruciate ligament rupture in 5086 patients requiring ligament reconstruction. Bone Joint J 2013 Jan;95-B(1)59-64.
Competing interests: No competing interests
Excellent article, coherent, well written, thought-provoking and true.
Competing interests: No competing interests
I totally agree with the premise of the article. Having superficially investigated some controversial sports medicine treatments, such as platelet-rich plasma injections (only recently removed from the prohibited substance list), which mainly have an anecdotal evidence base; it seems much of the practice is, in fact, not evidence based. The drive of athletes to return from injury faster promotes action and not reaction from physicians; therefore making a RCT very difficult as few would be prepared to enter through risk of receiving the placebo. However, sports and exercise medicine is a fast-paced field in its infancy and it will be very interesting to see what the Danish Sports Medicine symposium yields.
Competing interests: No competing interests
Re: The evidence base for orthopaedics and sports medicine
Whilst I agree with the premise that the evidence base for orthopaedic surgery and sports medicine needs to be improved, we need to be careful about developing an over-reliance on randomised controlled trial data. This theme has previously been highlighted in a parody by Smith and Pell detailing a systematic review of parachutes to prevent death by “gravitational challenge” (1).
In particular randomised controlled trials struggle to provide true long term data (follow up over 10+ years) as patients are lost over time. This is especially problematic in injuries such as ACL tears – where the injury occurs at an early age, but sequalae such as osteoarthritis are often seen much later.
We must also remember that randomised controlled trial data is sometimes limited by its external validity. For example the use of extensively co-ordinated and controlled rehabilitation programmes often seen in randomised controlled trials of sporting injury are unlikely to be matched in the majority of current clinical practice.
In addition the clear difference between the needs of professional and recreational level athletes provides major difficulties in the development of randomised controlled trials with adequate numbers and adequate scope to provide a meaningful clinical impact.
Choosing the right type of evidence to move current orthopaedic & sports medicine practices forward is imperative and should not be limited to randomised controlled trial data alone. Selection is likely to be decided based on a combination of clinical need, intervention/outcome incidence, subject recruitment, potential outcomes, scientific rationale and the available current evidence.
Provision of a broad and varied evidence base will allow better patient selection for the correct type of clinical intervention.
1. Smith G, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. BMJ 2003;327: 1459-1461.
Competing interests: No competing interests