Journal»Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association
PURPOSE: We aimed to determine if the randomized controlled trials (RCTs) evaluated in the most recent meta-analysis on arthroscopic surgery for degenerative knee arthritis included documented trials of appropriate conservative treatment prior to randomization.
METHODS: We selected all RCTs of the most recent meta-analysis by Brignardello-Petersen and recorded for each RCT, if physiotherapy prior to randomization was mandatory. We compared the treatment effect of arthroscopy in studies in which physiotherapy prior to randomization was mandatory versus studies in which it was not. This review was registered in the PROSPERO database (CRD42017070091).
RESULTS: Of the 13 RCTs in the meta-analysis, there were 2 in which physiotherapy prior to randomization was mandatory. In 1 additional multicenter RCT, prior conservative treatment was mentioned as mandatory in the publication, but not in the protocol. The treatment effects attributed to arthroscopy in terms of short-term pain (P = .0037), short-term function (P = .0309), and long-term function (P = .0012) were larger in studies in which prior physiotherapy was mandatory.
CONCLUSIONS: Although the most recent meta-analysis claims that it is based "on patients who do not respond to conservative treatment," physiotherapy was mandatory prior to randomization only in 2 of the 13 studies. As several orthopaedic guidelines recommend that the first line of treatment in patients with degenerative arthritis of the knee should be conservative, for instance with physiotherapy, and the question of performing arthroscopy arises once conservative treatment fails, 11 of the 13 RCTs failed to adhere to these accepted guidelines. Therefore, patient selection in these 11 studies may not represent the typical indications for arthroscopy, where patients have tried conservative management prior to being offered surgery. When comparing studies where prior physiotherapy was mandatory to studies in which it was not mandatory, there were statistically significant effects favoring arthroscopy in terms of pain in the short term, and for function both in the short and the long term. These findings suggest that the treatment effects attributed to arthroscopy were higher when prior physiotherapy was mandatory. Given these findings, the external validity of most of these RCTs, and the resulting "strong recommendation against the use of arthroscopy in nearly all patients with degenerative knee disease," is called into question.
LEVEL OF EVIDENCE: Level II, systematic review of Level I and II studies.
Objective To investigate whether the number of hyaluronic acid (HA) injections in a sodium hyaluronate (Hyalgan) course of therapy alters effectiveness in reducing knee osteoarthritis (OA) pain. Data Sources Electronic databases, including PubMed and Embase, were searched from January 1980 until November 2015. Study Selection We included clinical studies that evaluated the effectiveness of a course of 3 or 5 weekly intra-articular injections of Hyalgan to treat knee OA pain. We also included clinical studies evaluating the effectiveness of a 3-week course of other Food and Drug Administration–approved HA treatments of knee OA pain. Twenty-four studies were identified, comprising 2168 study participants in 30 treated cohorts. Data Extraction We determined effect sizes for selected studies by extracting knee OA pain scores before and after HA or control treatments. Meta-regressions were implemented to determine whether the number of weekly injections in a course of Hyalgan therapy modified outcomes. Data Synthesis The pooled estimate for relief from baseline pain was −31.4 (SE, 5.46; 95% confidence interval [CI], −45.5 to −17.4) with a 3-week course of Hyalgan and −32.2 (SE, 5.25; 95% CI, −45.6 to −18.7) with a 5-week course of Hyalgan. Findings from the meta-analysis indicate relief of knee OA pain with a 3-week course of Hyalgan is similar to that with a 5-week course of Hyalgan ( P =.916). The pooled estimate for relief from baseline pain with a 3-week course of other HA products was −29.4 (SE, 4.98; 95% CI, −42.2 to −16.6), also indicating pain relief with a 3-week course of Hyalgan is similar to that with a 3-week course of other HA products ( P =.696). Conclusions There was no statistical difference between reduction in knee OA pain with a 3-week course of Hyalgan compared with reduction in knee OA pain with a 5-week course of Hyalgan or a 3-week course of other HA products. These findings demonstrate that comparable knee OA pain relief is achieved with a 3-week course of Hyalgan and the 2 control groups.
OBJECTIVE: To investigate whether the number of hyaluronic acid (HA) injections in a Hyalgan(®) course of therapy alters effectiveness in reducing knee osteoarthritis (OA) pain.
DATA SOURCES: Electronic databases, including PubMed and EMBase, were searched from January 1980 until November 2015.
STUDY SELECTION: We included clinical studies that evaluated the effectiveness of a course of three or five weekly intra-articular injections of Hyalgan to treat knee OA pain. We also included clinical studies evaluating the effectiveness of a three-week course of other FDA-approved HA treatments of knee OA pain. Twenty-four studies were identified, comprising 2,168 study participants in 30 treated cohorts.
DATA EXTRACTION: We determined effect sizes for selected studies by extracting knee OA pain scores before and after HA or control treatments. Meta-regressions were implemented to determine whether the number of weekly injections in a course of Hyalgan therapy modified outcomes.
DATA SYNTHESIS: The pooled estimate for relief from baseline pain was -31.4 (5.46 SE; 95% confidence interval [CI], -45.5, -17.4) with a three-week course of Hyalgan and -32.2 (5.25; CI, -45.6, -18.7) with a five-week course of Hyalgan. Findings from the meta-analysis indicate relief of knee OA pain with a three-week course of Hyalgan is similar to that with a five-week course of Hyalgan (P = .916). The pooled estimate for relief from baseline pain with a three-week course of other HA products was -29.4 (4.98; CI, -42.2, -16.6), also indicating pain relief with a three-week course of Hyalgan is similar to that with a three-week course of other HA products (P = .696).
CONCLUSIONS: There was no statistical difference between reduction in knee OA pain with a three-week course of Hyalgan compared to reduction in knee OA pain with a five-week course of Hyalgan or a three-week course of other HA products. These findings demonstrate that comparable knee OA pain relief is achieved with a three-week course of Hyalgan and the two control groups.
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.
BACKGROUND: The prevalence of knee osteoarthritis (OA)/degenerative joint disease (DJD) is increasing in the USA. Systematic reviews of treatment efficacy and adverse events (AEs) of hyaluronic acid (HA) injections report conflicting evidence about the balance of benefits and harms. We review evidence on efficacy and AEs of intraarticular viscosupplementation with HA in older individuals with knee osteoarthritis and account for differences in these conclusions from another systematic review.
METHODS: We searched PubMed and eight other databases and gray literature sources from 1990 to December 12, 2014. Double-blind placebo-controlled randomized controlled trials (RCTs) reporting functional outcomes or quality-of-life; RCTs and observational studies on delay/avoidance of arthroplasty; RCTs, case reports, and large cohort studies and case series assessing safety; and systematic reviews reporting on knee pain were considered for inclusion. A standardized, pre-defined protocol was applied by two independent reviewers to screen titles and abstracts, review full text, and extract details on study design, interventions, outcomes, and quality. We compared our results with those of a prior systematic review and found them to be discrepant; our analysis of why this discrepancy occurred is the focus of this manuscript.
RESULTS: Eighteen RCTs reported functional outcomes: pooled analysis of ten placebo-controlled, blinded trials showed a standardized mean difference of -0.23 (95 % confidence interval (CI) -0.45 to -0.01) favoring HA at 6 months. Studies reported few serious adverse events (SAEs) and no significant differences in non-serious adverse events (NSAEs) (relative risk (RR) [95 % CI] 1.03 [0.93-1.15] or SAEs (RR [95 % CI] 1.39 [0.78-2.47]). A recent prior systematic review reported similar functional outcomes, but significant SAE risk. Differences in SAE inclusion and synthesis accounted for the disparate conclusions.
CONCLUSIONS: Trials show a small but significant effect of HA on function on which recent systematic reviews agree, but lack of AE synthesis standardization leads to opposite conclusions about the balance of benefits and harms. A limitation of the re-analysis of the prior systematic review is that it required imputation of missing data.
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.
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.
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.
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.
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.
We aimed to determine if the randomized controlled trials (RCTs) evaluated in the most recent meta-analysis on arthroscopic surgery for degenerative knee arthritis included documented trials of appropriate conservative treatment prior to randomization.
METHODS:
We selected all RCTs of the most recent meta-analysis by Brignardello-Petersen and recorded for each RCT, if physiotherapy prior to randomization was mandatory. We compared the treatment effect of arthroscopy in studies in which physiotherapy prior to randomization was mandatory versus studies in which it was not. This review was registered in the PROSPERO database (CRD42017070091).
RESULTS:
Of the 13 RCTs in the meta-analysis, there were 2 in which physiotherapy prior to randomization was mandatory. In 1 additional multicenter RCT, prior conservative treatment was mentioned as mandatory in the publication, but not in the protocol. The treatment effects attributed to arthroscopy in terms of short-term pain (P = .0037), short-term function (P = .0309), and long-term function (P = .0012) were larger in studies in which prior physiotherapy was mandatory.
CONCLUSIONS:
Although the most recent meta-analysis claims that it is based "on patients who do not respond to conservative treatment," physiotherapy was mandatory prior to randomization only in 2 of the 13 studies. As several orthopaedic guidelines recommend that the first line of treatment in patients with degenerative arthritis of the knee should be conservative, for instance with physiotherapy, and the question of performing arthroscopy arises once conservative treatment fails, 11 of the 13 RCTs failed to adhere to these accepted guidelines. Therefore, patient selection in these 11 studies may not represent the typical indications for arthroscopy, where patients have tried conservative management prior to being offered surgery. When comparing studies where prior physiotherapy was mandatory to studies in which it was not mandatory, there were statistically significant effects favoring arthroscopy in terms of pain in the short term, and for function both in the short and the long term. These findings suggest that the treatment effects attributed to arthroscopy were higher when prior physiotherapy was mandatory. Given these findings, the external validity of most of these RCTs, and the resulting "strong recommendation against the use of arthroscopy in nearly all patients with degenerative knee disease," is called into question.
LEVEL OF EVIDENCE:
Level II, systematic review of Level I and II studies.
