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Systematic review

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Journal Medicine
Year 2016
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This systematic review was performed to investigate the ethical justification, methodological quality, validity and safety of placebo controls in randomized placebo-controlled surgical trials.Central, MEDLINE, and EMBASE were systematically searched to identify randomized controlled trials comparing a surgical procedure to a placebo. "Surgical procedure" was defined as a medical procedure involving an incision with instruments. Placebo was defined as a blinded sham operation involving no change to the structural anatomy and without an expectable physiological response in the target body compartment.Ten randomized placebo-controlled controlled surgical trials were included, all of them published in high-ranking medical journals (mean impact factor: 20.1). Eight of 10 failed to show statistical superiority of the experimental intervention. Serious adverse events did not differ between the groups (rate ratio [RR] 1.38, 95% confidence interval [CI]: 0.92-2.06, P = 0.46). None of the trials had a high risk of bias in any domain. The ethical justification for the use of a placebo control remained unclear in 2 trials.Placebo-controlled surgical trials are feasible and provide high-quality data on efficacy of surgical treatments. The surgical placebo entails a considerable risk for study participants. Consequently, a placebo should be used only if justified by the clinical question and by methodological necessity. Based on the current evidence, a pragmatic proposal for the use of placebo controls in future randomized controlled surgical trials is made.

Systematic review

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Journal British journal of sports medicine
Year 2015
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OBJECTIVE: To determine benefits and harms of arthroscopic knee surgery involving partial meniscectomy, debridement, or both for middle aged or older patients with knee pain and degenerative knee disease. DESIGN: Systematic review and meta-analysis. MAIN OUTCOME MEASURES: Pain and physical function. DATA SOURCES: Systematic searches for benefits and harms were carried out in Medline, Embase, CINAHL, Web of Science, and the Cochrane Central Register of Controlled Trials (CENTRAL) up to August 2014. Only studies published in 2000 or later were included for harms. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials assessing benefit of arthroscopic surgery involving partial meniscectomy, debridement, or both for patients with or without radiographic signs of osteoarthritis were included. For harms, cohort studies, register based studies, and case series were also allowed. RESULTS: The search identified nine trials assessing the benefits of knee arthroscopic surgery in middle aged and older patients with knee pain and degenerative knee disease. The main analysis, combining the primary endpoints of the individual trials from three to 24 months postoperatively, showed a small difference in favour of interventions including arthroscopic surgery compared with control treatments for pain (effect size 0.14, 95% confidence interval 0.03 to 0.26). This difference corresponds to a benefit of 2.4 (95% confidence interval 0.4 to 4.3) mm on a 0-100 mm visual analogue scale. When analysed over time of follow-up, interventions including arthroscopy showed a small benefit of 3-5 mm for pain at three and six months but not later up to 24 months. No significant benefit on physical function was found (effect size 0.09, -0.05 to 0.24). Nine studies reporting on harms were identified. Harms included symptomatic deep venous thrombosis (4.13 (95% confidence interval 1.78 to 9.60) events per 1000 procedures), pulmonary embolism, infection, and death. CONCLUSIONS: The small inconsequential benefit seen from interventions that include arthroscopy for the degenerative knee is limited in time and absent at one to two years after surgery. Knee arthroscopy is associated with harms. Taken together, these findings do not support the practise of arthroscopic surgery for middle aged or older patients with knee pain with or without signs of osteoarthritis. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014009145.

Systematic review

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Journal BMJ (Clinical research ed.)
Year 2015
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OBJECTIVE: To determine benefits and harms of arthroscopic knee surgery involving partial meniscectomy, debridement, or both for middle aged or older patients with knee pain and degenerative knee disease. DESIGN: Systematic review and meta-analysis. MAIN OUTCOME MEASURES: Pain and physical function. DATA SOURCES: Systematic searches for benefits and harms were carried out in Medline, Embase, CINAHL, Web of Science, and the Cochrane Central Register of Controlled Trials (CENTRAL) up to August 2014. Only studies published in 2000 or later were included for harms. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials assessing benefit of arthroscopic surgery involving partial meniscectomy, debridement, or both for patients with or without radiographic signs of osteoarthritis were included. For harms, cohort studies, register based studies, and case series were also allowed. RESULTS: The search identified nine trials assessing the benefits of knee arthroscopic surgery in middle aged and older patients with knee pain and degenerative knee disease. The main analysis, combining the primary endpoints of the individual trials from three to 24 months postoperatively, showed a small difference in favour of interventions including arthroscopic surgery compared with control treatments for pain (effect size 0.14, 95% confidence interval 0.03 to 0.26). This difference corresponds to a benefit of 2.4 (95% confidence interval 0.4 to 4.3) mm on a 0-100 mm visual analogue scale. When analysed over time of follow-up, interventions including arthroscopy showed a small benefit of 3-5 mm for pain at three and six months but not later up to 24 months. No significant benefit on physical function was found (effect size 0.09, -0.05 to 0.24). Nine studies reporting on harms were identified. Harms included symptomatic deep venous thrombosis (4.13 (95% confidence interval 1.78 to 9.60) events per 1000 procedures), pulmonary embolism, infection, and death. CONCLUSIONS: The small inconsequential benefit seen from interventions that include arthroscopy for the degenerative knee is limited in time and absent at one to two years after surgery. Knee arthroscopy is associated with harms. Taken together, these findings do not support the practise of arthroscopic surgery for middle aged or older patients with knee pain with or without signs of osteoarthritis. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014009145.

Systematic review

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Authors Barlow T , Downham C , Griffin D
Journal Acta orthopaedica Belgica
Year 2015
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Knee arthroscopy has historically been a common treatment for knee osteoarthritis. A Cochrane review of the literature up to 2006 has resulted in guidance that arthroscopy is not effective in knee osteoarthritis. It cited that deficiencies in the evidence base prevented widespread acceptance of the recommendations. The aim of this review is to update the evidence base for the efficacy of arthroscopy in knee osteoarthritis. The authors searched CINHAL, EMBASE, MEDLINE, and CENTRAL for randomised controlled trials that compared arthroscopic surgery in knee osteoarthritis with a control group (e.g. lavage, best medical care). The primary outcome measure was patient reported functional outcome. The study methodology was registered on Prospero, a systematic review register: Registration number CRD42012002891. Five randomised controlled trials included 516 patients, almost double the 271 episodes contained in previous reviews. Two high quality studies, according to the Jadad classification, published since the Cochrane review, addressed many of the methodological flaws criticised in previous reviews. However, certain subgroup analyses (e.g. patients with meniscal tears and mechanical symptoms) are still underpowered.

Systematic review

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Journal BMJ open
Year 2015
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OBJECTIVES: To analyse the impact of placebo effects on outcome in trials of selected minimally invasive procedures and to assess reported adverse events in both trial arms. DESIGN: A systematic review and meta-analysis. DATA SOURCES AND STUDY SELECTION: We searched MEDLINE and Cochrane library to identify systematic reviews of musculoskeletal, neurological and cardiac conditions published between January 2009 and January 2014 comparing selected minimally invasive with placebo (sham) procedures. We searched MEDLINE for additional randomised controlled trials published between January 2000 and January 2014. DATA SYNTHESIS: Effect sizes (ES) in the active and placebo arms in the trials' primary and pooled secondary end points were calculated. Linear regression was used to analyse the association between end points in the active and sham groups. Reported adverse events in both trial arms were registered. RESULTS: We included 21 trials involving 2519 adult participants. For primary end points, there was a large clinical effect (ES≥0.8) after active treatment in 12 trials and after sham procedures in 11 trials. For secondary end points, 7 and 5 trials showed a large clinical effect. Three trials showed a moderate difference in ES between active treatment and sham on primary end points (ES ≥0.5) but no trials reported a large difference. No trials showed large or moderate differences in ES on pooled secondary end points. Regression analysis of end points in active treatment and sham arms estimated an R(2) of 0.78 for primary and 0.84 for secondary end points. Adverse events after sham were in most cases minor and of short duration. CONCLUSIONS: The generally small differences in ES between active treatment and sham suggest that non-specific mechanisms, including placebo, are major predictors of the observed effects. Adverse events related to sham procedures were mainly minor and short-lived. Ethical arguments frequently raised against sham-controlled trials were generally not substantiated.

Systematic review

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Journal CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne
Year 2014
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BACKGROUND: Arthroscopic surgery for degenerative meniscal tears is a commonly performed procedure, yet the role of conservative treatment for these patients is unclear. This systematic review and meta-analysis evaluates the efficacy of arthroscopic meniscal débridement in patients with knee pain in the setting of mild or no concurrent osteoarthritis of the knee in comparison with nonoperative or sham treatments. METHODS: We searched MEDLINE, Embase and the Cochrane databases for randomized controlled trials (RCTs) published from 1946 to Jan. 20, 2014. Two reviewers independently screened all titles and abstracts for eligibility. We assessed risk of bias for all included studies and pooled outcomes using a random-effects model. Outcomes (i.e., function and pain relief) were dichotomized to short-term (< 6 mo) and long-term (< 2 yr) data. RESULTS: Seven RCTs (n = 805 patients) were included in this review. The pooled treatment effect of arthroscopic surgery did not show a significant or minimally important difference (MID) between treatment arms for long-term functional outcomes (standardized mean difference [SMD] 0.07, 95% confidence interval [CI] -0.10 to 0.23). Short-term functional outcomes between groups were significant but did not exceed the threshold for MID (SMD 0.25, 95% CI 0.02 to 0.48). Arthroscopic surgery did not result in a significant improvement in pain scores in the short term (mean difference [MD] 0.20, 95% CI -0.67 to 0.26) or in the long term (MD -0.06, 95% CI -0.28 to 0.15). Statistical heterogeneity was low to moderate for the outcomes. INTERPRETATION: There is moderate evidence to suggest that 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. A trial of nonoperative management should be the first-line treatment for such patients.

Systematic review

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Authors Maly MR , Robbins SM
Journal Osteoarthritis and cartilage / OARS, Osteoarthritis Research Society
Year 2014
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OBJECTIVE: To highlight research studies examining rehabilitation for hip and knee osteoarthritis (OA), as well as the outcome measures used to assess treatment efficacy, published in 2013. DESIGN: A systematic search was performed in Medline, CIHAHL and Embase databases from January to December 2013. The search was limited to 2013, human studies, and English. Rehabilitation intervention studies included were prospective controlled designs. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to evaluate the quality of evidence. First, individual articles were rated for quality. Second, articles were grouped based on outcome: OA disease markers, pain, physical function (self-reported, performance), and health. RESULTS: Of 503 titles reviewed, 36 studies were included. The outcome measures related to OA disease markers were organized into subthemes of anthropometrics, biomechanics and physiology. The quality of evidence was of moderate, high, and low quality for anthropometric, biomechanical and physiological measures respectively. These studies supported the use of diet for weight loss combined with exercise. Bodies of evidence that showed the efficacy of exercise and passive strategies (thermal/electrical modalities, traction, manual therapy) for reducing pain were of low and moderate quality respectively. The evidence supporting diet and exercise, physiotherapy, and passive strategies to improve physical function was of moderate quality. Evidence supporting exercise to improve psychological factors was of moderate quality. CONCLUSIONS: Exercise combined with diet for weight loss should be the mainstays of rehabilitation for people with knee and hip OA to provide benefit to OA disease markers, pain, physical function, and health.

Systematic review

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Journal Ontario health technology assessment series
Year 2014
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BACKGROUND: Patients with knee pain as a result of osteoarthritis or degenerative meniscal injury may seek treatment through arthroscopic surgery. How effective arthroscopic debridement with or without meniscectomy is for relieving pain and improving patients' functional outcomes is uncertain. OBJECTIVES: To conduct an evidence update of an evidence-based analysis (EBA) conducted in 2005 to determine if arthroscopic debridement for osteoarthritis of the knee or for meniscal injury from degenerative causes improve patient outcomes. DATA SOURCES: A literature search was performed using Ovid MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, Embase, and all EBM databases, for studies published from January 1, 2005, to February 4, 2014. REVIEW METHODS: A systematic review of the literature was conducted, limited to randomized controlled trials (RCTs) that examined the effectiveness of arthroscopic debridement with or without meniscectomy. Quality assessment of the body of literature was conducted using Grading of Recommendations Assessment, Development, and Evaluation (GRADE). RESULTS: A total of 8 RCTs were identified, 2 from the original EBA plus 6 that were published since that time. The studies included patients with a range of indications for treatment and severity of osteoarthritis. Moderate-quality evidence showed no statistically significant difference in pain or functional status between patients who received arthroscopic treatment versus placebo (e.g., sham surgery). Low-quality evidence showed no statistically significant difference in pain or functional status between patients who received arthroscopic treatment versus usual care (e.g., physical therapy). LIMITATIONS: Heterogeneity across the study populations, interventions, and reported measures limited the ability to calculate a summary effect estimate; however, all studies demonstrated consistency in their findings. CONCLUSIONS: The evidence does not show the superiority of arthroscopic debridement with or without meniscectomy in patients with osteoarthritis of the knee or with meniscal injury from degenerative causes.

Systematic review

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Authors Spahn G , Hofmann GO , Klinger HM
Journal Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA
Year 2013
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PURPOSE: Knee osteoarthritis is one of the most common orthopaedic diseases. Therapeutic options for this disease include conservative treatments and arthroscopic debridement and partial or complete replacement. This meta-analysis aimed to collect and analyse the available information on the effects of arthroscopic joint debridement related to the clinical outcomes, the required conversion to replacement and the factors for patient selection. METHODS: A search for publications was performed in the PubMed, Cochrane and EMBASE medical databases. The primary search resulted in a total of 1,512 citations. The results from 30 papers were included in this study. The extracted dates were listed in a standardised protocol. The statistical evaluation was performed using Comprehensive Meta-analysis software (V2 Biostat, Englewood, NJ, USA). RESULTS: No randomised study that compared conservative and arthroscopic treatments for knee osteoarthritis was found. Most studies reported middle-term results after arthroscopic operations. The results of these studies showed excellent or good outcomes in more than 60 % of all patients. These results were correlated with a significant increase in the knee scores from baseline to follow-up; the standardised difference in means was 2.3 (CI 95 % 1.5-3.0, p < 0.001). The required conversion rate to replacement increased as the follow-up interval increased. The rates were as follows: 1 year-6.1 % (CI 95 %, 2.1-16.6 %), 2 years-16.8 % (CI 95 %, 10.2-26.3 %), 3 years-21.7 % (CI 95 %, 15.5-29.1 %) and 4 years-34.1 % (CI 95 %, 22.8-47.6 %). The mean survival time was 42.7 (CI 95 %, 14.5-71.1) months. Numerous factors influenced the outcome, including the radiological stage of the osteoarthritis and individual patient factors (e.g. time of history of osteoarthritis, weight and smoking). The local knee findings, such as axial dysalignment, missing effusion and massive crepitus, were also correlated with patient outcome. CONCLUSION: Arthroscopic joint debridement is a potential and sufficient treatment for knee osteoarthritis in a middle-term time interval. This procedure results in an excellent or good outcome in approximately 60 % of patients in approximately 5 years. LEVEL OF EVIDENCE: Systematic review of studies, Level III.

Systematic review

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Journal Cochrane database of systematic reviews (Online)
Year 2010
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BACKGROUND: Osteoarthritis is the most common form of joint disorder and a leading cause of pain and physical disability. Observational studies suggested a benefit for joint lavage, but recent, sham-controlled trials yielded conflicting results, suggesting joint lavage not to be effective. OBJECTIVES: To compare joint lavage with sham intervention, placebo or non-intervention control in terms of effects on pain, function and safety outcomes in patients with knee osteoarthritis. SEARCH STRATEGY: We searched CENTRAL, MEDLINE, EMBASE, and CINAHL up to 3 August 2009, checked conference proceedings, reference lists, and contacted authors. SELECTION CRITERIA: We included studies if they were randomised or quasi-randomised trials that compared arthroscopic and non-arthroscopic joint lavage with a control intervention in patients with osteoarthritis of the knee. We did not apply any language restrictions. DATA COLLECTION AND ANALYSIS: Two independent review authors extracted data using standardised forms. We contacted investigators to obtain missing outcome information. We calculated standardised mean differences (SMDs) for pain and function, and risk ratios for safety outcomes. We combined trials using inverse-variance random-effects meta-analysis. MAIN RESULTS: We included seven trials with 567 patients. Three trials examined arthroscopic joint lavage, two non-arthroscopic joint lavage and two tidal irrigation. The methodological quality and the quality of reporting was poor and we identified a moderate to large degree of heterogeneity among the trials (I(2) = 65%). We found little evidence for a benefit of joint lavage in terms of pain relief at three months (SMD -0.11, 95% CI -0.42 to 0.21), corresponding to a difference in pain scores between joint lavage and control of 0.3 cm on a 10-cm visual analogue scale (VAS). Results for improvement in function at three months were similar (SMD -0.10, 95% CI -0.30 to 0.11), corresponding to a difference in function scores between joint lavage and control of 0.2 cm on a WOMAC disability sub-scale from 0 to 10. For pain, estimates of effect sizes varied to some degree depending on the type of lavage, but this variation was likely to be explained by differences in the credibility of control interventions: trials using sham interventions to closely mimic the process of joint lavage showed a null-effect. Reporting on adverse events and drop out rates was unsatisfactory, and we were unable to draw conclusions for these secondary outcomes. AUTHORS' CONCLUSIONS: Joint lavage does not result in a relevant benefit for patients with knee osteoarthritis in terms of pain relief or improvement of function.