Classification of meniscal tears. Evidence from randomized placebo controlled trials

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1 Treatment for degenerative meniscal tears - surgery, exercise or both? 1 Jonas Bloch Thorlund Associate professor (MSc, PhD) Research Unit for Musculoskeletal Function and Physiotherapy (FOF) Department of Sports Science and Clinical Biomechanics Classification of meniscal tears Traumatic tears Bucket handle lesion in an otherwise healthy meniscus Degenerative tears Tear in a degenerative meniscus with fibrillations (Poehling et al., CSM 1990) 1

2 Patients: Mean age 52 years Men (x-military) Osteoarthritis patients (mild: 25%, moderate: 50%, severe: 25%) Randomized to: Lavage (n=61) Débridement (n=59) (meniscal resection/smoothing, loose debris removed and cartilage shaving) Placebo surgery, i.e. skin incisions only (n=60) 2

3 Patients: Mean age 52 years 60% men No osteoarthritis Degenerative meniscal tear Gradual symptom onset: 65% After exercise/hard work or sudden after twisting: 35% Randomized to: Surgery, i.e. meniscal resection only (n=70) Placebo surgery, i.e. diagnostic arthroscopy (n=76) Synthesis of the evidence Aim To synthesize the evidence from RCT s on benefits and harms of knee arthroscopy for middle-aged and older patients 3

4 Methods PROSPERO protocol no.: CRD Reporting according to the PRISMA statement Data sources: Medline, EMBASE, CINAHL, Web of Science and CENTRAL up until August 2014 Eligibility criteria: RCT s assessing benefit of arthroscopic surgery (APM and/or debridement) for patients with or without radiographic signs of knee OA For harms we also allowed case, cohort and register-based studies (published year 2000 or later) Methods Outcomes: Benefit: Pain and physical function (using a pre-specified hierarchy for selection - Juhl et al., Arthritis 2012) Harms: All meta-analysis on most serious and frequent AE Study selection and data collection: Study screening/inclusion Risk of bias assessment Data extraction Independently by two reviewers disagreements resolved by consensus Results 9 trials, including 1270 patients (meta-analysis) (No RCT s on knee arthroscopy for young patients identified) Study design: - Surgery vs. sham (placebo) surgery - Surgery + exercise vs. exercise - (Surgery vs. exercise) 4

5 Results Mean age in studies years (2 SD) Age distribution 95% 55.6 mean 70.2 (2 SD) Meniskkirurgi 2014: 68% over 40 år (n=15 579) (Landspatientregisteret, ) Age Results Degree of degenerative knee disease (osteoarthritis) Normal Grade 1 Grade 2 Grade 3 Grade 4 Degenerative meniscal tear + (Kellgren & Lawrence scoring system) Effect - pain (In middle-aged and older patients) Summary of primary outcomes (range 3-24 months after surgery) Effect size: 0.20 = small 0.50 = moderate >0.80 = large 5

6 Effect - pain Results visualized in 100 mm VAS scale (follow-up range 3-24 months) Both groups è Surgical intervention è Control interventions è Baseline pain 52 mm mm Follow-up pain 44.9% 0 4.1% or 2.4 mm diff. 100 mm 40.8% mm (VAS=Visual Analogue Scale) (Thorlund, Juhl, Roos, Lohmander, BMJ 2015) Effect - pain (In middle-aged and older patients) 4.6 mm Clinical relevant difference mm Effect - physical function (In middle-aged and older patients) No difference at any time point 6

7 Sensitivity analysis Harms Studies (no. of patients) AE per 1000 (95% CI) I2 (%) DVT 5 ( ) 4.1 ( ) 98.3 PE 6 ( ) 1.5 ( ) 98.6 Infection 4 ( ) 2.1 ( ) 99.3 Death 2 ( ) 1.0 ( ) 90.3 Adverse Event (AE) Adverse events are real however uncertainty about the precision of estimates Mechanical symptoms (Catching, locking, grinding, clicking of the knee) Often argued as an important indication for meniscal surgery Study Study size (n) Surgery group (n) Control group (n) Moseley Kirkley /92 172/180 patients 38/86 Yim /54 54/54 Sihvonen /70 37/76 Gauffin /75 41/75 7

8 Mechanical symptoms Observational cohort: 915 patients undergoing APM (64% mechanical symptoms) Results indicated poorer outcomes for patients with mechanical symptoms (Sihvonen et al.; OAC 2016) Exercise as treatment for degenerative meniscal tears 1 Exercise as treatment for patients with degenerative meniscal tears 3 mm VAS Exercise vs Surgery+exercise 8

9 82 patients (35% women), mean age 49 years 3 months follow-up: Global rating scale of change (GRC) (Range: very much worse to completely recovered ) Surgical group reported: much better Exercise group reported: much better Waiting for the full study report on patient reported outcomes (Stensrud et al. ; AJPMR 2014) This review found that outpatient physical therapy associated with a home exercise program improved patient-reported knee function and ROM and reduced effusion in patients who had undergone partial arthroscopic meniscectomy. However, the results presented in this review are based on studies of moderate to high risk of bias and should be interpreted with caution. (Dias et al.; JOSPT 2013) Degenerative meniscal tears and knee osteoarthritis 1 9

10 Link to knee osteoarthritis X-rays has traditionally been used to diagnose knee OA (radiographic knee OA) X-rays are not sensitive to early structural changes and have only moderate correlation with symptoms Today knee OA is primarily a clinical diagnosis and do not rely on x-rays Link to knee osteoarthritis Patients aged >50 years without radiographic knee OA Mean age: 62.2 yrs Mean BMI: 27.9 kg/m 2 55% women (Guermazi et al.; BMJ 2012) Meniscal tears on MRI are common MRI investigation of 991 random people aged years n=991 18% with radiographic knee OA Bars denote 95% CI Knee symptoms equally frequent in patients with and without meniscal tear (Englund et al., NEJM 2008) 10

11 Link to knee osteoarthritis Development of symptoms explained by knee OA rather than presence of meniscal tears (Englund et al., A&R 2007) Exercise as treatment for knee OA Pain: 44 trials (3 537 patients) ES: 0.49 ( , 95% CI) High-quality evidence Physical function: NSAID effect on pain: ES: 0.29 ( , 95% CI) (Zhang et al.; OAC 2010) 44 trials (3 913 patients) ES: 0.52 ( , 95% CI) Moderate quality evidence Quality of life: 13 trials (1 073 patients) ES: 0.28 ( , 95% CI) High-quality evidence Effect size (ES): 0.20 = small 0.50 = moderate >0.80 = large (Fransen et al.; Cochrane Syst Rev 2015) THANK YOU Research Unit for Musculoskeletal Function and Physiotherapy (FOF) jthorlund@health.sdu.dk 11

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Teppo Järvinen University of Helsinki, Helsinki, FINLAND

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Teppo Järvinen University of Helsinki, Helsinki, FINLAND PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)