Surgery, Needle Fasciotomy, or Collagenase Injection for Dupuytren Contracture : A Randomized Controlled Trial.

BACKGROUND: Surgery, needle fasciotomy, and collagenase injection are used to treat Dupuytren contracture. The treatment decision requires balancing initial morbidity and costs of surgery against its potential long-term benefits over needle fasciotomy and collagenase. OBJECTIVE: To compare the effectiveness of surgery, needle fasciotomy, and collagenase injection at 3 months and 2 years (secondary time points of the trial). DESIGN: A multicenter, randomized, outcome assessor-blinded, superiority trial. (ClinicalTrials.gov: NCT03192020). SETTING: 6 public hospitals in Finland. PARTICIPANTS: 302 persons with treatment-naive Dupuytren contracture (contracture angle <135°). INTERVENTION: Surgery (n = 101), needle fasciotomy (n = 101), or collagenase (n = 100). MEASUREMENTS: The primary outcome was the success rate, defined as greater than 50% contracture release and patients reaching the patient acceptable symptom state. Secondary outcomes included hand function, pain, quality of life, patient satisfaction, residual contracture angle, finger flexion, risk for retreatment, and serious adverse events. RESULTS: A total of 292 (97%) and 284 (94%) participants completed the 3-month and 2-year follow-ups. Success rates were similar at 3 months: 71% (95% CI, 62% to 80%) for surgery, 73% (CI, 64% to 82%) for needle fasciotomy, and 73% (CI, 64% to 82%) for collagenase. At 2 years, surgery had superior success rates compared with both needle fasciotomy (78% vs. 50%; adjusted risk difference [aRD], 0.30 [CI, 0.17 to 0.43]) and collagenase (78% vs. 65%; aRD, 0.13 [CI, 0.01 to 0.26]). Secondary analyses paralleled with the primary analysis. LIMITATION: Participants were not blinded. CONCLUSION: Initial outcomes are similar between the treatments, but at 2 years success rates were maintained in the surgery group but were lower with both needle fasciotomy and collagenase despite retreatments. PRIMARY FUNDING SOURCE: Research Council of Finland.

Arthroscopic Partial Meniscectomy for a Degenerative Meniscus Tear Is Not Cost Effective Compared With Placebo Surgery: An Economic Evaluation Based on the FIDELITY Trial Data.

BACKGROUND: In patients with a degenerative tear of the medial meniscus, recent meta-analyses and systematic reviews have shown no treatment benefit of arthroscopic partial meniscectomy (APM) over conservative treatment or placebo surgery. Yet, advocates of APM still argue that APM is cost effective. Giving advocates of APM their due, we note that there is evidence from the treatment of other musculoskeletal complaints to suggest that a treatment may prove cost effective even in the absence of improvements in efficacy outcomes, as it may lead to other benefits, such as diminished productivity loss and reduced costs, and so the question of cost effectiveness needs to be answered for APM. QUESTIONS/PURPOSES: (1) Does APM result in lower postoperative costs compared with placebo surgery? (2) Is APM cost-effective compared with placebo surgery? METHODS: One hundred forty-six adults aged 35 to 65 years with knee symptoms consistent with a degenerative medial meniscus tear and no knee osteoarthritis according to the American College of Rheumatology clinical criteria were randomized to APM (n = 70) or placebo surgery (n = 76). In the APM and placebo surgery groups, mean age was 52 ± 7 years and 52 ± 7 years, and 60% (42 of 70) and 62% (47 of 76) of participants were men, respectively. There were no between-group differences in baseline characteristics. In both groups, a standard diagnostic arthroscopy was first performed. Thereafter, in the APM group, the torn meniscus was trimmed to solid meniscus tissue, whereas in the placebo surgery group, APM was carefully mimicked but no resection of meniscal tissue was performed; as such, surgical costs were the same in both arms and were not included in the analyses. All patients received identical postoperative care including a graduated home-based exercise program. At the 2-year follow-up, two patients were lost to follow-up, both in the placebo surgery group. Cost effectiveness over the 2-year trial period was computed as incremental net monetary benefit (INMB) for improvements in quality-adjusted life years (QALY), using both the societal (primary) and healthcare system (secondary) perspectives. To be able to consider APM cost effective, the CEA analysis should yield a positive INMB value. Nonparametric bootstrapping was used to assess uncertainty. Several one-way sensitivity analyses were also performed. RESULTS: APM did not deliver lower postoperative costs, nor did it convincingly improve quality of life scores when compared with placebo surgery. From a societal perspective, APM was associated with € 971 (95% CI -2013 to 4017) higher costs and 0.015 (95% CI -0.011 to 0.041) improved QALYs over 2-year follow-up compared with placebo surgery. Both differences were statistically inconclusive (a wide 95% CI that crossed the line of no difference). Using the conventional willingness to pay (WTP) threshold of € 35,000 per QALY, APM resulted in a negative INMB of € -460 (95% CI -3757 to 2698). In our analysis, APM would result in a positive INMB only when the WTP threshold rises to about € 65,000 per QALY. The wide 95% CIs suggests uncertain cost effectiveness irrespective of chosen WTP threshold. CONCLUSION: The results of this study lend further support to clinical practice guidelines recommending against the use of APM in patients with a degenerative meniscus tear. Given the robustness of existing evidence demonstrating no benefit or cost effectiveness of APM over nonsurgical treatment or placebo surgery, future research is unlikely to alter this conclusion.Level of Evidence Level III, economic analysis.

The Finnish spine register (FinSpine): development, design, validation and utility.

PURPOSE: Our aim was to develop a nationwide, computer-based, Spine Register (FinSpine) for monitoring surgical activity, quality of surgery, long-term outcomes, and effectiveness of treatment. In this paper, we describe our experiences in the development and implementation of the register. METHODS: The register was developed by a steering group, consisting of orthopedic surgeons and neurosurgeons from the whole country. We strived to develop a register which would be in active use by spine surgeons and enable collection of Patient Reported Outcome and Experience Measures (PROMs and PREMs) automatically and prospectively. We are actively promoting the use of the register in order to gain a nationwide coverage and achieve high response-rates from both surgeons and patients. RESULTS: The use of FinSpine started in 2016 and it has been granted continuous funding from the Finnish Institute for Health and Welfare from the 1st of January 2023 onwards. Currently the register is used by 19/23 (83%) public hospitals and the use is expanding to private hospitals as well. The response-rate of surgeons is currently 80%. The response-rate of patients is on average 56% but reaches up to 90% in hospitals using register-coordinators. CONCLUSION: The use of FinSpine is increasing. By gaining a larger coverage and completeness, the data can be used for research purposes which we believe will influence decision making and ultimately improve the outcomes and quality of life of the patients. Comparison with other national spine registers is possible, since FinSpine includes similar baseline characteristics and outcome measures (e.g., ODI, EQ-5D, VAS).

Incidence and risk factors of spinal cord stimulation for persistent or recurrent pain after lumbar spine surgery: a population-based study.

PURPOSE: This study aims to elucidate the incidence of and independent risk factors for spinal cord stimulator implantations for patients who underwent lumbar spine surgery. METHODS: The PERFormance, Effectiveness, and Cost of Treatment (PERFECT) episodes database, which was established for selected diseases and procedures in Finland, includes all patients who underwent lumbar spine surgery for degenerative spine conditions or spinal cord stimulation (SCS) in Finland from 1986 to 2018. The data on age, sex, hospital diagnoses, surgical procedures, and causes of death were imported from the Finnish national registers into the PERFECT database. RESULTS: Between 1986 and 2018, 157,824 patients had their first lumbar spine procedure and for 1769 (1.1%) of them, a subsequent SCS procedure was observed during the follow-up. The cumulative incidence of SCS for persistent or recurrent pain after lumbar disk herniation, spinal stenosis, degenerative disk disease, and spondylolysis and spondylolisthesis surgery at 15 years was 1.2%, 1.0%, 2.7%, and 2.6% respectively. At 15 years, the cumulative incidence of SCS for persistent or recurrent pain after lumbar spine surgery after five or more lumbar spinal operations was 11.9%. CONCLUSION: Repeated surgery was the most prominent significant risk factor for SCS for persistent or recurrent pain after lumbar spine surgery. The risk of SCS for persistent or recurrent pain after lumbar spine surgery increases significantly along with the number of lumbar spine procedures. When considering repeated lumbar spine surgery, careful evaluation of treatment options should take place to ensure good patient outcomes.

Exercise therapy for chronic low back pain.

BACKGROUND: Low back pain has been the leading cause of disability globally for at least the past three decades and results in enormous direct healthcare and lost productivity costs. OBJECTIVES: The primary objective of this systematic review is to assess the impact of exercise treatment on pain and functional limitations in adults with chronic non-specific low back pain compared to no treatment, usual care, placebo and other conservative treatments. SEARCH METHODS: We searched CENTRAL (which includes the Cochrane Back and Neck trials register), MEDLINE, Embase, CINAHL, PsycINFO, PEDro, SPORTDiscus, and trials registries (ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform), and conducted citation searching of relevant systematic reviews to identify additional studies. The review includes data for trials identified in searches up to 27 April 2018. All eligible trials have been identified through searches to 7 December 2020, but have not yet been extracted; these trials will be integrated in the next update. SELECTION CRITERIA: We included randomised controlled trials that assessed exercise treatment compared to no treatment, usual care, placebo or other conservative treatment on the outcomes of pain or functional limitations for a population of adult participants with chronic non-specific low back pain of more than 12 weeks' duration. DATA COLLECTION AND ANALYSIS: Two authors screened and assessed studies independently, with consensus. We extracted outcome data using electronic databases; pain and functional limitations outcomes were re-scaled to 0 to 100 points for meta-analyses where 0 is no pain or functional limitations. We assessed risk of bias using the Cochrane risk of bias (RoB) tool and used GRADE to evaluate the overall certainty of the evidence. When required, we contacted study authors to obtain missing data. To interpret meta-analysis results, we considered a 15-point difference in pain and a 10-point difference in functional limitations outcomes to be clinically important for the primary comparison of exercise versus no treatment, usual care or placebo. MAIN RESULTS: We included 249 trials of exercise treatment, including studies conducted in Europe (122 studies), Asia (38 studies), North America (33 studies), and the Middle East (24 studies). Sixty-one per cent of studies (151 trials) examined the effectiveness of two or more different types of exercise treatment, and 57% (142 trials) compared exercise treatment to a non-exercise comparison treatment. Study participants had a mean age of 43.7 years and, on average, 59% of study populations were female. Most of the trials were judged to be at risk of bias, including 79% at risk of performance bias due to difficulty blinding exercise treatments. We found moderate-certainty evidence that exercise treatment is more effective for treatment of chronic low back pain compared to no treatment, usual care or placebo comparisons for pain outcomes at earliest follow-up (MD -15.2, 95% CI -18.3 to -12.2), a clinically important difference. Certainty of evidence was downgraded mainly due to heterogeneity. For the same comparison, there was moderate-certainty evidence for functional limitations outcomes (MD -6.8 (95% CI -8.3 to -5.3); this finding did not meet our prespecified threshold for minimal clinically important difference. Certainty of evidence was downgraded mainly due to some evidence of publication bias.  Compared to all other investigated conservative treatments, exercise treatment was found to have improved pain (MD -9.1, 95% CI -12.6 to -5.6) and functional limitations outcomes (MD -4.1, 95% CI -6.0 to -2.2). These effects did not meet our prespecified threshold for clinically important difference. Subgroup analysis of pain outcomes suggested that exercise treatment is probably more effective than education alone (MD -12.2, 95% CI -19.4 to -5.0) or non-exercise physical therapy (MD -10.4, 95% CI -15.2 to -5.6), but with no differences observed for manual therapy (MD 1.0, 95% CI -3.1 to 5.1). In studies that reported adverse effects (86 studies), one or more adverse effects were reported in 37 of 112 exercise groups (33%) and 12 of 42 comparison groups (29%). Twelve included studies reported measuring adverse effects in a systematic way, with a median of 0.14 (IQR 0.01 to 0.57) per participant in the exercise groups (mostly minor harms, e.g. muscle soreness), and 0.12 (IQR 0.02 to 0.32) in comparison groups. AUTHORS' CONCLUSIONS: We found moderate-certainty evidence that exercise is probably effective for treatment of chronic low back pain compared to no treatment, usual care or placebo for pain. The observed treatment effect for the exercise compared to no treatment, usual care or placebo comparisons is small for functional limitations, not meeting our threshold for minimal clinically important difference. We also found exercise to have improved pain (low-certainty evidence) and functional limitations outcomes (moderate-certainty evidence) compared to other conservative treatments; however, these effects were small and not clinically important when considering all comparisons together. Subgroup analysis suggested that exercise treatment is probably more effective than advice or education alone, or electrotherapy, but with no differences observed for manual therapy treatments.

Patient education booklet to support evidence-based low back pain care in primary care - a cluster randomized controlled trial.

BACKGROUND: Inappropriate imaging and low-value care for low back pain (LBP) are common. A new patient-education booklet was created to overcome identified barriers to the delivery of recommended care, including the use of inappropriate imaging. Our aim was to assess the effectiveness of this booklet as part of primary care for LBP patients in comparison to usual care. METHODS: A cluster-randomized trial was performed. The intervention involved providing practitioners with the new patient-education booklet and a 30-min training session on its use. The booklet was provided during the clinical consult to all consenting LBP patients in the intervention group. Primary outcomes were the proportion of patients presenting with LBP who underwent imaging examinations during the first three months of follow-up and PROMIS PF-20 (Patient-Reported Outcomes Measurement Information System, 20-item physical functioning short form) change between baseline and three-month follow-up. Secondary outcomes, including sick leave and imaging examinations at 12 months, were investigated. Logistic regression using GEE-estimation was used for dichotomous outcomes, Poisson regression using GEE-estimation for count outcomes, and linear mixed models for continuous outcomes. RESULTS: Using the patient education booklet appeared to substantially reduce the proportion of LBP patients who underwent an imaging examination at three months, but the result was not statistically significant (OR 0.57, 95% confidence interval (Cl) 0.27 to 1.22). At 12 months, the effect was slightly larger and statistically significant (OR 0.50, 95%Cl 0.30 to 0.83, p = 0.008). No difference was observed in the PROMIS PF-20 T-score change between baseline and 3 months or 12 months (p = 0.365 and p = 0.923, respectively). The number of sick leave days in the intervention group was less than that in the control group at 3 months (RR 0.47, 95%Cl 0.26 to 0.83, p = 0.010) and at 12 months (RR 0.36, 95%Cl 0.18 to 0.72, p = 0.004). CONCLUSIONS: The booklet appeared to be effective in reducing the proportion of LBP patients who underwent imaging examinations over 12 months. The intervention had no discernible effect on the PROMIS PF20 T-score change. The number of sick leave days was substantially lower in the intervention group. TRIAL REGISTRATION: ISRCTN, ISRCTN14389368 , Registered 4 April 2019-Retrospectively registered.

Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: a 5-year follow-up of a randomised, placebo surgery controlled clinical trial.

OBJECTIVES: To assess the long-term efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy (primary comparison), a placebo surgical intervention, and with a non-operative alternative, exercise therapy (secondary comparison). METHODS: We conducted a multicentre, three group, randomised, controlled superiority trial. We included 210 patients aged 35-65 years, who had symptoms consistent with shoulder impingement syndrome for more than 3 months. 175 participants (83%) completed the 5 years follow-up. Patient enrolment began on 1 February 2005 and the 5-year follow-up was completed by 10 October 2018. The two primary outcomes were shoulder pain at rest and on arm activity measured with Visual Analogue Scale (VAS). Minimally important difference (MID) was set at 15. We used a mixed-model repeated measurements analysis of variance with participant as a random factor, the baseline value as a covariate and assuming a covariance structure with compound symmetry. RESULTS: In the primary intention to treat analysis (ASD vs diagnostic arthroscopy), there were no between-group differences that exceeded the MID for the primary outcomes at 5 years: the mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -2.0 (95% CI -8.5 to 4.6; p=0.56) at rest and -8.0 (-17.3 to 1.3; p=0.093) on arm activity. There were no between-group differences in the secondary outcomes or adverse events that exceeded the MID. In our secondary comparison (ASD vs exercise therapy), the mean differences between groups (ASD minus exercise therapy) in pain VAS were 1.0 (-5.6 to 7.6; p=0.77) at rest and -3.9 (-12.8 to 5.1; p=0.40) on arm activity. There were no significant between-group differences for the secondary outcomes or adverse events. CONCLUSIONS: ASD provided no benefit over diagnostic arthroscopy (or exercise therapy) at 5 years for patients with shoulder impingement syndrome.

Arthroscopic partial meniscectomy for a degenerative meniscus tear: a 5 year follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial.

OBJECTIVES: To assess the long-term effects of arthroscopic partial meniscectomy (APM) on the development of radiographic knee osteoarthritis, and on knee symptoms and function, at 5 years follow-up. DESIGN: Multicentre, randomised, participant- and outcome assessor-blinded, placebo-surgery controlled trial. SETTING: Orthopaedic departments in five public hospitals in Finland. PARTICIPANTS: 146 adults, mean age 52 years (range 35-65 years), with knee symptoms consistent with degenerative medial meniscus tear verified by MRI scan and arthroscopically, and no clinical signs of knee osteoarthritis were randomised. INTERVENTIONS: APM or placebo surgery (diagnostic knee arthroscopy). MAIN OUTCOME MEASURES: We used two indices of radiographic knee osteoarthritis (increase in Kellgren and Lawrence grade ≥1, and increase in Osteoarthritis Research Society International (OARSI) atlas radiographic joint space narrowing and osteophyte sum score, respectively), and three validated patient-relevant measures of knee symptoms and function (Western Ontario Meniscal Evaluation Tool (WOMET), Lysholm, and knee pain after exercise using a numerical rating scale). RESULTS: There was a consistent, slightly greater risk for progression of radiographic knee osteoarthritis in the APM group as compared with the placebo surgery group (adjusted absolute risk difference in increase in Kellgren-Lawrence grade ≥1 of 13%, 95% CI -2% to 28%; adjusted absolute mean difference in OARSI sum score 0.7, 95% CI 0.1 to 1.3). There were no relevant between-group differences in the three patient-reported outcomes: adjusted absolute mean differences (APM vs placebo surgery), -1.7 (95% CI -7.7 to 4.3) in WOMET, -2.1 (95% CI -6.8 to 2.6) in Lysholm knee score, and -0.04 (95% CI -0.81 to 0.72) in knee pain after exercise, respectively. The corresponding adjusted absolute risk difference in the presence of mechanical symptoms was 18% (95% CI 5% to 31%); there were more symptoms reported in the APM group. All other secondary outcomes comparisons were similar. CONCLUSIONS: APM was associated with a slightly increased risk of developing radiographic knee osteoarthritis and no concomitant benefit in patient-relevant outcomes, at 5 years after surgery. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01052233 and NCT00549172).

Correction of leg-length discrepancy among meat cutters with low back pain: a randomized controlled trial.

BACKGROUND: The etiology of non-specific low back pain (LBP) is complex and not well understood. LBP is common and causes a remarkable health burden worldwide. Leg-length discrepancy (LLD) is potentially a risk factor for development of LBP, although this relationship has been questioned. Yet only one randomized controlled study (RCT) has been performed. The objective of our study was to evaluate the effect of insoles with leg-length discrepancy (LLD) correction compared to insoles without LLD correction among meat cutters in a RCT-design. METHODS: The study population consisted 387 meat cutters who were over 35 years old and had been working 10 years or more. The LLD measurement was done by a laser ultrasound technique. All workers with an LLD of at least 5 mm and an LBP intensity of at least 2 on a 10-cm Visual Analog Scale were eligible. The LLD of all the participants in the intervention group was corrected 70%, which means that if the LLD was for example 10 mm the correction was 7 mm. The insoles were used at work for eight hours per day. The control group had insoles without LLD correction. The primary outcome was between-group difference in LBP intensity. Secondary outcomes included sciatic pain intensity, disability (Roland Morris), RAND-36, the Oswestry Disability Index, physician visits and days on sick leave over the first year. We used a repeated measures regression analysis with adjustments for age, gender and BMI. The hurdle model was used for days on sick leave. RESULTS: In all, 169 workers were invited and 114 (67%) responded. Of them, 42 were eligible and were randomized to the intervention (n = 20) or control group (n = 22). The workers in the intervention group had a higher improvement in LBP intensity (- 2.6; 95% confidence intervals - 3.7 - - 1.4), intensity of sciatic pain (- 2.3; - 3.4 - - 1.07) and RAND-36 physical functioning (9.6; 1.6-17.6) and a lesser likelihood of sick leaves (OR -3.7; - 7.2 - -0.2). CONCLUSIONS: Correction of LLD with insoles was an effective intervention among workers with LBP and a standing job. TRIAL REGISTRATION: ISRCTN11898558 . Registration date 11. Feb 2011. BioMed Central Ltd.

Surgical techniques for degenerative cervical spine in Finland from 1999 to 2015.

PURPOSE: The purpose of this study is to assess the trends and regional variations in the operative techniques used for degenerative or rheumatoid cervical spine disease in Finland between 1999 and 2015. METHODS: The Finnish Hospital Discharge Register (FHDR) was searched for the data on all the primary operations for degenerative cervical spine disease (DCSD) or rheumatoid atlanto-axial subluxation (rAAS). Operative codes were used to identify the patients from the FHDR and combined with diagnosis codes to verify patient inclusion. The patients were classified into three groups: anterior cervical decompression and fusion (ACDF), posterior decompression and fusion (PDF) and decompression. RESULTS: A total of 19,701 primary operations were included. The adjusted incidence of ACDF rose from 6.5 to 27.3 operations/100,000 adults. ACDF became the favoured technique in all the diagnostic groups except AAS, and by 2015, ACDF comprised 84.5% of the operations. The incidence of PDF for DCSD increased from 0.2 to 0.7/100,000 people. Solely decompressive operations declined from 13.7 to 4.0 operations/100,000 people. The regional differences in the incidence of operations were most marked in the incidence of ACDF, with overall incidences ranging from 11.2 to 37.0 operations/100,000. The distribution of the operative techniques used varied as well. CONCLUSIONS: Between 1999 and 2015, the operative techniques used for DCSD changed from prevalently decompressive to utilising ACDF in 68.8 to 91.0% of the operations, depending on the treating hospital. ACDF became the most commonly applied technique for all degenerative diagnoses except AAS.

Surgery for degenerative cervical spine disease in Finland, 1999-2015.

BACKGROUND: The incidence of surgery for degenerative cervical spine disease (DCSD) has risen by almost 150% in the USA in the last three decades and stabilized at slightly over 70 operations/100,000 people. There has been significant regional variation in the operation incidences. We aim to assess the diagnosis-based, age-adjusted trends in the operation incidences and the regional variation in Finland between 1999 and 2015. METHODS: Data from the Finnish Hospital Discharge Register (FHDR), the Cause of Death Register, and the registers of the Social Insurance Institution were combined to analyze all the primary operations for DCSD or rheumatoid atlanto-axial subluxation (rAAS). Combinations of the operative and the diagnosis codes were used to classify the patients into five diagnostic groups. RESULTS: A total of 19,701 primary operations were included. The age-adjusted operation incidence rose from 21.0 to 36.5/100,000 people between 1999 and 2013 and plateaued thereafter. The incidence of surgery for radiculopathy increased from 13.1 to 23.3 operations/100,000 people, and the incidence of surgery for DCM increased from 5.8 to 7.0 operations/100,000 people. The rise was especially pronounced in surgery for foraminal stenosis, which increased from 5.3 to 12.4 operations/100,000 people. Of the five diagnostic groups, only operations for rAAS declined. Operations increased especially in the 40- to 65-year-old age group. The overall operation incidences varied from 18.3 to 43.1 operations/100,000 people between the university hospitals. CONCLUSIONS: The age-adjusted incidence of surgery for DCSD has risen in Finland by 76%, but the rise has plateaued. Surgery for radiculopathy, especially for foraminal stenosis, increased more steeply than surgery for degenerative medullopathy, with vast regional differences in the operation incidences.

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

OBJECTIVE: To assess if arthroscopic partial meniscectomy (APM) is superior to placebo surgery in the treatment of patients with degenerative tear of the medial meniscus. METHODS: In this multicentre, randomised, participant-blinded and outcome assessor-blinded, placebo-surgery controlled trial, 146 adults, aged 35-65 years, with knee symptoms consistent with degenerative medial meniscus tear and no knee osteoarthritis were randomised to APM or placebo surgery. The primary outcome was the between-group difference in the change from baseline in the Western Ontario Meniscal Evaluation Tool (WOMET) and Lysholm knee scores and knee pain after exercise at 24 months after surgery. Secondary outcomes included the frequency of unblinding of the treatment-group allocation, participants' satisfaction, impression of change, return to normal activities, the incidence of serious adverse events and the presence of meniscal symptoms in clinical examination. Two subgroup analyses, assessing the outcome on those with mechanical symptoms and those with unstable meniscus tears, were also carried out. RESULTS: In the intention-to-treat analysis, there were no significant between-group differences in the mean changes from baseline to 24 months in WOMET score: 27.3 in the APM group as compared with 31.6 in the placebo-surgery group (between-group difference, -4.3; 95% CI, -11.3 to 2.6); Lysholm knee score: 23.1 and 26.3, respectively (-3.2; -8.9 to 2.4) or knee pain after exercise, 3.5 and 3.9, respectively (-0.4; -1.3 to 0.5). There were no statistically significant differences between the two groups in any of the secondary outcomes or within the analysed subgroups. CONCLUSIONS: In this 2-year follow-up of patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after APM were no better than those after placebo surgery. No evidence could be found to support the prevailing ideas that patients with presence of mechanical symptoms or certain meniscus tear characteristics or those who have failed initial conservative treatment are more likely to benefit from APM.

Pure intervention effect or effect in routine health care - blinded or non-blinded randomized controlled trial.

BACKGROUND: Randomized trials provide the most valid evidence of effectiveness of interventions. The study aims to determine the primary study question for randomized controlled trials; to evaluate the study questions in trials on effectiveness of arthroscopic meniscectomy for meniscal rupture of the knee; and to explore the clinical and research implications. METHODS: Previous studies on benchmarking controlled trials were utilized. A literature search was undertaken to find the trials on arthroscopic surgery for meniscal rupture of the knee, data was extracted, and checked for accuracy twice. RESULTS: The first question in RCTs is whether to assess the pure intervention effect, or intervention effect in routine health care circumstances. The former necessitates a double blinded design and the latter a non-blind design. The trials on arthroscopic meniscectomy of the knee showed considerable differences in study characteristics. CONCLUSIONS: The study question in RCTs on pure intervention effect dictates use of blinded design, while question of intervention effect in routine health care dictates use of non-blinded design. Blinding should not be considered a validity criterion when study question is on effectiveness in routine health care. When informing patients, the potential for other effects besides the pure intervention effect should be considered.

Treatment after traumatic shoulder dislocation: a systematic review with a network meta-analysis.

OBJECTIVE: To review and compare treatments (1) after primary traumatic shoulder dislocation aimed at minimising the risk of chronic shoulder instability and (2) for chronic post-traumatic shoulder instability. DESIGN: Intervention systematic review with random effects network meta-analysis and direct comparison meta-analyses. DATA SOURCES: Electronic databases (Ovid MEDLINE, Cochrane Clinical Trials Register, Cochrane Database of Systematic Reviews, Embase, Scopus, CINAHL, Ovid MEDLINE Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE Daily, DARE, HTA, NHSEED, Web of Science) and reference lists were searched from inception to 15 January 2018. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised trials comparing any interventions either after a first-time, traumatic shoulder dislocation or chronic post-traumatic shoulder instability, with a shoulder instability, function or quality of life outcome. RESULTS: Twenty-two randomised controlled trials were included. There was moderate quality evidence suggesting that labrum repair reduced the risk of future shoulder dislocation (relative risk 0.15; 95% CI 0.03 to 0.8, p=0.026), and that with non-surgical management 47% of patients did not experience shoulder redislocation. Very low to low-quality evidence suggested no benefit of immobilisation in external rotation versus internal rotation. There was low-quality evidence that an open procedure was superior to arthroscopic surgery for preventing shoulder redislocations. CONCLUSIONS: There was moderate-quality evidence that half of the patients managed with physiotherapy after a first-time traumatic shoulder dislocation did not experience recurrent shoulder dislocations. If chronic instability develops, surgery could be considered. There was no evidence regarding the effectiveness of surgical management for post-traumatic chronic shoulder instability.

Multidisciplinary biopsychosocial rehabilitation for subacute low back pain.

BACKGROUND: Low back pain (LBP) is associated with enormous personal and societal burdens, especially when it reaches the chronic stage of the disorder (pain for a duration of more than three months). Indeed, individuals who reach the chronic stage tend to show a more persistent course, and they account for the majority of social and economic costs. As a result, there is increasing emphasis on the importance of intervening at the early stages of LBP.According to the biopsychosocial model, LBP is a condition best understood with reference to an interaction of physical, psychological, and social influences. This has led to the development of multidisciplinary biopsychosocial rehabilitation (MBR) programs that target factors from the different domains, administered by healthcare professionals from different backgrounds.This review is an update of a Cochrane Review on MBR for subacute LBP, which was published in 2003. It is part of a series of reviews on MBR for musculoskeletal pain published by the Cochrane Back and Neck Group and the Cochrane Musculoskeletal Group. OBJECTIVES: To examine the effectiveness of MBR for subacute LBP (pain for a duration of six to 12 weeks) among adults, with a focus on pain, back-specific disability, and work status. SEARCH METHODS: We searched for relevant trials in any language by a computer-aided search of CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO and two trials registers. Our search is current to 13 July 2016. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of adults with subacute LBP. We included studies that investigated a MBR program compared to any type of control intervention. We defined MBR as an intervention that included a physical component (e.g. pharmacological, physical therapy) in combination with either a psychological, social, or occupational component (or any combination of these). We also required involvement of healthcare professionals from at least two different clinical backgrounds with appropriate training to deliver the component for which they were responsible. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. In particular, the data extraction and 'risk of bias' assessment were conducted by two people, independently. We used the Cochrane tool to assess risk of bias and the GRADE approach to assess the overall quality of the evidence for each outcome. MAIN RESULTS: We included a total of nine RCTs (981 participants) in this review. Five studies were conducted in Europe and four in North America. Sample sizes ranged from 33 to 351. The mean age across trials ranged between 32.0 and 43.7 years.All included studies were judged as having high risk of performance bias and high risk of detection bias due to lack of blinding, and four of the nine studies suffered from at least one additional source of possible bias.In MBR compared to usual care for subacute LBP, individuals receiving MBR had less pain (four studies with 336 participants; SMD -0.46, 95% CI -0.70 to -0.21, moderate-quality of evidence due to risk of bias) and less disability (three studies with 240 participants; SMD -0.44, 95% CI -0.87 to -0.01, low-quality of evidence due to risk of bias and inconsistency), as well as increased likelihood of return-to-work (three studies with 170 participants; OR 3.19, 95% CI 1.46 to 6.98, very low-quality of evidence due to serious risk of bias and imprecision) and fewer sick leave days (two studies with 210 participants; SMD -0.38 95% CI -0.66 to -0.10, low-quality of evidence due to risk of bias and imprecision) at 12-month follow-up. The effect sizes for pain and disability were low in terms of clinical meaningfulness, whereas effects for work-related outcomes were in the moderate range.However, when comparing MBR to other treatments (i.e. brief intervention with features from a light mobilization program and a graded activity program, functional restoration, brief clinical intervention including education and advice on exercise, and psychological counselling), we found no differences between the groups in terms of pain (two studies with 336 participants; SMD -0.14, 95% CI -0.36 to 0.07, low-quality evidence due to imprecision and risk of bias), functional disability (two studies with 345 participants; SMD -0.03, 95% CI -0.24 to 0.18, low-quality evidence due to imprecision and risk of bias), and time away from work (two studies with 158 participants; SMD -0.25 95% CI -0.98 to 0.47, very low-quality evidence due to serious imprecision, inconsistency and risk of bias). Return-to-work was not reported in any of the studies.Although we looked for adverse events in both comparisons, none of the included studies reported this outcome. AUTHORS' CONCLUSIONS: On average, people with subacute LBP who receive MBR will do better than if they receive usual care, but it is not clear whether they do better than people who receive some other type of treatment. However, the available research provides mainly low to very low-quality evidence, thus additional high-quality trials are needed before we can describe the value of MBP for clinical practice.

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

BACKGROUND: Arthroscopic partial meniscectomy is one of the most common orthopedic procedures, yet rigorous evidence of its efficacy is lacking. METHODS: We conducted a multicenter, randomized, double-blind, sham-controlled trial in 146 patients 35 to 65 years of age who had knee symptoms consistent with a degenerative medial meniscus tear and no knee osteoarthritis. Patients were randomly assigned to arthroscopic partial meniscectomy or sham surgery. The primary outcomes were changes in the Lysholm and Western Ontario Meniscal Evaluation Tool (WOMET) scores (each ranging from 0 to 100, with lower scores indicating more severe symptoms) and in knee pain after exercise (rated on a scale from 0 to 10, with 0 denoting no pain) at 12 months after the procedure. RESULTS: In the intention-to-treat analysis, there were no significant between-group differences in the change from baseline to 12 months in any primary outcome. The mean changes (improvements) in the primary outcome measures were as follows: Lysholm score, 21.7 points in the partial-meniscectomy group as compared with 23.3 points in the sham-surgery group (between-group difference, -1.6 points; 95% confidence interval [CI], -7.2 to 4.0); WOMET score, 24.6 and 27.1 points, respectively (between-group difference, -2.5 points; 95% CI, -9.2 to 4.1); and score for knee pain after exercise, 3.1 and 3.3 points, respectively (between-group difference, -0.1; 95% CI, -0.9 to 0.7). There were no significant differences between groups in the number of patients who required subsequent knee surgery (two in the partial-meniscectomy group and five in the sham-surgery group) or serious adverse events (one and zero, respectively). CONCLUSIONS: In this trial involving patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after arthroscopic partial meniscectomy were no better than those after a sham surgical procedure. (Funded by the Sigrid Juselius Foundation and others; ClinicalTrials.gov number, NCT00549172.).

Elevated risk of early reoperation in total hip replacement during the stage of unit closure: A population-based registry study of total hip and knee replacements in Finland, 1998-2011.

BACKGROUND AND PURPOSE: The effects of launch or closure of an entire arthroplasty unit on the first or last patients treated in these units have not been studied. Using a 3-year follow-up, we investigated whether patients who were treated at the launch or closure stage of an arthroplasty unit of a hospital would have a higher risk of reoperation than patients treated in-between at the same units. PATIENTS AND METHODS: From the Finnish Arthroplasty Register, we identified all the units that had performed total joint arthroplasty and the units that were launched or closed in Finland between 1998 and 2011. The risks of reoperation within 3 years for the 41,748 total hip and knee replacements performed due to osteoarthritis in these units were modeled with Cox proportional-hazards regression, separately for hip and knee and for the launch and the closure stage. RESULTS: The unadjusted and adjusted hazard ratios (HRs) for total hip and knee replacements performed in the initial stage of activity of the units that were launched were similar to the reoperation risks in patients who were operated in these units after the early stage of activity. The unadjusted and risk-adjusted HRs for early reoperation after total hip replacement (THR) were increased at the closure stage (adjusted HR = 1.8, 95% CI: 1.2-2.8). The reoperation risk at the closure stage after total knee replacement (TKR) was not increased. INTERPRETATION: The results indicate that closure of units performing total hip replacements poses an increased risk of reoperation. Closures need to be managed carefully to prevent the quality from deteriorating when performing the final arthroplasties.

Individual and Regional-level Factors Contributing to Variation in Length of Stay After Cerebral Infarction in Six European Countries.

Using patient-level data for cerebral infarction cases in 2007, gathered from Finland, Hungary, Italy, the Netherlands, Scotland and Sweden, we studied the variation in risk-adjusted length of stay (LoS) of acute hospital care and 1-year mortality, both within and between countries. In addition, we analysed the variance of LoS and associations of selected regional-level factors with LoS and 1-year mortality after cerebral infarction. The data show that LoS distributions are surprisingly different across countries and that there is significant deviation in the risk-adjusted regional-level LoS in all of the countries studied. We used negative binomial regression to model the individual-level LoS, and random intercept models and ordinary least squares regression for the regional-level analysis of risk-adjusted LoS, variance of LoS, 1-year risk-adjusted mortality and crude mortality for a period of 31-365 days. The observed variations between regions and countries in both LoS and mortality were not fully explained by either patient-level or regional-level factors. The results indicate that there may exist potential for efficiency gains in acute hospital care of cerebral infarction and that healthcare managers could learn from best practices.

Radiofrequency denervation for chronic low back pain.

BACKGROUND: Radiofrequency (RF) denervation, an invasive treatment for chronic low back pain (CLBP), is used most often for pain suspected to arise from facet joints, sacroiliac (SI) joints or discs. Many (uncontrolled) studies have shown substantial variation in its use between countries and continued uncertainty regarding its effectiveness. OBJECTIVES: The objective of this review is to assess the effectiveness of RF denervation procedures for the treatment of patients with CLBP. The current review is an update of the review conducted in 2003. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, three other databases, two clinical trials registries and the reference lists of included studies from inception to May 2014 for randomised controlled trials (RCTs) fulfilling the inclusion criteria. We updated this search in June 2015, but we have not yet incorporated these results. SELECTION CRITERIA: We included RCTs of RF denervation for patients with CLBP who had a positive response to a diagnostic block or discography. We applied no language or date restrictions. DATA COLLECTION AND ANALYSIS: Pairs of review authors independently selected RCTs, extracted data and assessed risk of bias (RoB) and clinical relevance using standardised forms. We performed meta-analyses with clinically homogeneous studies and assessed the quality of evidence for each outcome using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. MAIN RESULTS: In total, we included 23 RCTs (N = 1309), 13 of which (56%) had low RoB. We included both men and women with a mean age of 50.6 years. We assessed the overall quality of the evidence as very low to moderate. Twelve studies examined suspected facet joint pain, five studies disc pain, two studies SI joint pain, two studies radicular CLBP, one study suspected radiating low back pain and one study CLBP with or without suspected radiation. Overall, moderate evidence suggests that facet joint RF denervation has a greater effect on pain compared with placebo over the short term (mean difference (MD) -1.47, 95% confidence interval (CI) -2.28 to -0.67). Low-quality evidence indicates that facet joint RF denervation is more effective than placebo for function over the short term (MD -5.53, 95% CI -8.66 to -2.40) and over the long term (MD -3.70, 95% CI -6.94 to -0.47). Evidence of very low to low quality shows that facet joint RF denervation is more effective for pain than steroid injections over the short (MD -2.23, 95% CI -2.38 to -2.08), intermediate (MD -2.13, 95% CI -3.45 to -0.81), and long term (MD -2.65, 95% CI -3.43 to -1.88). RF denervation used for disc pain produces conflicting results, with no effects for RF denervation compared with placebo over the short and intermediate term, and small effects for RF denervation over the long term for pain relief (MD -1.63, 95% CI -2.58 to -0.68) and improved function (MD -6.75, 95% CI -13.42 to -0.09). Lack of evidence of short-term effectiveness undermines the clinical plausibility of intermediate-term or long-term effectiveness. When RF denervation is used for SI joint pain, low-quality evidence reveals no differences from placebo in effects on pain (MD -2.12, 95% CI -5.45 to 1.21) and function (MD -14.06, 95% CI -30.42 to 2.30) over the short term, and one study shows a small effect on both pain and function over the intermediate term. RF denervation is an invasive procedure that can cause a variety of complications. The quality and size of original studies were inadequate to permit assessment of how often complications occur. AUTHORS' CONCLUSIONS: The review authors found no high-quality evidence suggesting that RF denervation provides pain relief for patients with CLBP. Similarly, we identified no convincing evidence to show that this treatment improves function. Overall, the current evidence for RF denervation for CLBP is very low to moderate in quality; high-quality evidence is lacking. High-quality RCTs with larger patient samples are needed, as are data on long-term effects.