key: cord-0935310-8rgpr2lo authors: Blom, Ashley W; Donovan, Richard L; Beswick, Andrew D; Whitehouse, Michael R; Kunutsor, Setor K title: Common elective orthopaedic procedures and their clinical effectiveness: umbrella review of level 1 evidence date: 2021-07-08 journal: BMJ DOI: 10.1136/bmj.n1511 sha: 7302188ef9906714b5b31bf82cda3a99a91d2f9b doc_id: 935310 cord_uid: 8rgpr2lo OBJECTIVE: To determine the clinical effectiveness of common elective orthopaedic procedures compared with no treatment, placebo, or non-operative care and assess the impact on clinical guidelines. DESIGN: Umbrella review of meta-analyses of randomised controlled trials or other study designs in the absence of meta-analyses of randomised controlled trials. DATA SOURCES: Ten of the most common elective orthopaedic procedures—arthroscopic anterior cruciate ligament reconstruction, arthroscopic meniscal repair of the knee, arthroscopic partial meniscectomy of the knee, arthroscopic rotator cuff repair, arthroscopic subacromial decompression, carpal tunnel decompression, lumbar spine decompression, lumbar spine fusion, total hip replacement, and total knee replacement—were studied. Medline, Embase, Cochrane Library, and bibliographies were searched until September 2020. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Meta-analyses of randomised controlled trials (or in the absence of meta-analysis other study designs) that compared the clinical effectiveness of any of the 10 orthopaedic procedures with no treatment, placebo, or non-operative care. DATA EXTRACTION AND SYNTHESIS: Summary data were extracted by two independent investigators, and a consensus was reached with the involvement of a third. The methodological quality of each meta-analysis was assessed using the Assessment of Multiple Systematic Reviews instrument. The Jadad decision algorithm was used to ascertain which meta-analysis represented the best evidence. The National Institute for Health and Care Excellence Evidence search was used to check whether recommendations for each procedure reflected the body of evidence. MAIN OUTCOME MEASURES: Quality and quantity of evidence behind common elective orthopaedic interventions and comparisons with the strength of recommendations in relevant national clinical guidelines. RESULTS: Randomised controlled trial evidence supports the superiority of carpal tunnel decompression and total knee replacement over non-operative care. No randomised controlled trials specifically compared total hip replacement or meniscal repair with non-operative care. Trial evidence for the other six procedures showed no benefit over non-operative care. CONCLUSIONS: Although they may be effective overall or in certain subgroups, no strong, high quality evidence base shows that many commonly performed elective orthopaedic procedures are more effective than non-operative alternatives. Despite the lack of strong evidence, some of these procedures are still recommended by national guidelines in certain situations. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018115917. Protocol and registration 5 Indicate if a review protocol exists, if and where it can be accessed (such as web address), and, if available, provide registration information including registration number Methods Eligibility criteria 6 Specify study characteristics (such as PICOS, length of follow-up) and report characteristics (such as years considered, language, publication status) used as criteria for eligibility, giving rationale Study selection 17 Give numbers of studies screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage, ideally with a flow diagram Results; Appendix 6 Study characteristics 18 For each study, present characteristics for which data were extracted (such as study size, PICOS, follow-up period) and provide the citations Results; Table 2 Risk of bias within studies 19 Present data on risk of bias of each study and, if available, any outcome-level assessment (see item 12). Results; Table 3 Results of individual studies 20 For all outcomes considered (benefits or harms), present for each study (a) simple summary data for each intervention group and (b) effect estimates and confidence intervals, ideally with a forest plot Results; Table 2 Synthesis of results 21 Present results of each meta-analysis done, including confidence intervals and measures of consistency Results; Table 2 Risk of bias across studies 22 Present results of any assessment of risk of bias across studies (see item 15) Results; Table 3 Additional analysis 23 Give results of additional analyses, if done (such as sensitivity or subgroup analyses, meta-regression) (see item 16) Not applicable Discussion Summary of evidence 24 Summarise the main findings including the strength of evidence for each main outcome; consider their relevance to key groups (such as health care providers, users, and policy makers) Data extracted from each of the studies were relevant to the population characteristics, study design, exposure, and outcome.  Assessment of confounding We assessed confounding by ranking individual studies based on different adjustment levels and performed subgroup analyses to evaluate differences in the overall estimates according to levels of adjustment.  Assessment of study quality, including blinding of quality assessors; stratification or regression on possible predictors of study results Study quality was assessed based on the eleven-item Assessment of Multiple Systematic Reviews (AMSTAR) instrument, which includes ratings for quality in the search, analysis, and transparency of a meta-analysis. It has good reliability and external validity. The heterogeneity of the studies was quantified with I 2 statistic that provides the relative amount of variance of the summary effect due to the between-study heterogeneity.  Description of statistical methods in sufficient detail to be replicated Table 2  Results of sensitivity testing Table 3  Indication of statistical uncertainty of findings N/a Total hip replacement 1 exp Arthroplasty, Replacement, Hip/ (27189) 2 exp Osteoarthritis/ (63224) 3 (((comprehensive* or integrative or systematic*) adj3 (bibliographic* or review* or literature)) or (meta-analy* or metaanaly* or "research synthesis" or ((information or data) adj3 synthesis) or (data adj2 extract*))).ti,ab. or (cinahl or (cochrane adj3 trial*) or embase or medline or psyclit or (psycinfo not "psycinfo database") or pubmed or scopus or "sociological abstracts" or "web of science").ab. or ("cochrane database of systematic reviews" or evidence report technology assessment or evidence report technology assessment summary).jn. or Evidence Report: Technology Assessment*.jn. or ((review adj5 (rationale or evidence)).ti,ab. and review.pt.) or meta-analysis as topic/ or Meta-Analysis.pt. (457475) 4 1 and 2 and 3 (145) 5 limit 4 to (english language and humans) (135) Total knee replacement 1 exp Arthroplasty, Replacement, Knee/ (23882) 2 exp Osteoarthritis/ (63224) 3 (((comprehensive* or integrative or systematic*) adj3 (bibliographic* or review* or literature)) or (meta-analy* or metaanaly* or "research synthesis" or ((information or data) adj3 synthesis) or (data adj2 extract*))).ti,ab. or (cinahl or (cochrane adj3 trial*) or embase or medline or psyclit or (psycinfo not "psycinfo database") or pubmed or scopus or "sociological abstracts" or "web of science").ab. or ("cochrane database of systematic reviews" or evidence report technology assessment or evidence report technology assessment summary).jn. or Evidence Report: Technology Assessment*.jn. or ((review adj5 (rationale or evidence)).ti,ab. and review.pt.) or meta-analysis as topic/ or Meta-Analysis.pt. (457475) 4 1 and 2 and 3 (320) 5 limit 4 to (english language and humans) (303) Systematic reviews of randomised controlled trials 1b Individual randomised controlled trials 1c All or none randomised controlled trials 2a Systematic reviews of cohort studies 2b Individual cohort study or low quality randomised controlled trials 2c Outcomes' research; ecological studies 3a Systematic review of case-control studies 3b Individual case-control study 4 Case series 5 Expert opinion without explicit critical appraisal/pre-clinical biomechanical data 29. Overdevest GM, Jacobs W, Vleggeert-Lankamp C, Thome C, Gunzburg R, Peul W. Effectiveness of posterior decompression techniques compared with conventional laminectomy for lumbar stenosis. Ji, 2015 0 1 1 1 0 1 1 1 1 0 1 8 Karjalainen, 2019 1 1 1 1 1 1 1 1 1 1 1 11 Schemitsch, 2019 0 1 1 1 0 1 1 1 1 0 0 7 Arthroscopic subacromial decompression Karjalainen, 2019 1 1 1 1 1 1 1 1 1 1 1 11 Lahdeoja, 2020 1 1 1 1 0 1 1 1 1 1 1 10 Nazari, 2019 1 1 1 1 0 1 1 1 1 0 1 9 Carpal tunnel decompression Chen, 2014 0 1 1 1 0 1 1 1 1 1 0 8 Hu, 2016 0 1 1 1 0 1 0 0 1 1 1 7 Li, 2019 0 1 1 1 0 1 1 1 1 1 1 9 Sanati, 2011 0 1 1 1 0 1 1 1 1 0 1 8 Sayegh, 2014 0 1 1 1 0 1 1 1 1 1 1 9 Thoma, 2004 0 1 1 1 0 0 1 1 1 1 0 7 Vasiliadis, 2014 1 1 1 1 1 1 1 1 1 1 1 11 Verdugo, 2008 1 1 1 1 1 1 1 1 1 0 1 10 Zuo, 2015 0 1 1 1 1 1 1 1 1 0 1 9 21 Bai, 2019 1 1 1 1 0 1 1 1 1 1 1 10 Bydon, 2014 0 1 1 1 0 1 1 1 1 0 1 8 Hiratzka, 2015 0 0 1 1 1 1 0 0 1 0 1 6 Jacobs, 2012 1 1 1 1 1 1 1 1 1 1 1 11 Li, 2018 0 1 1 1 0 1 1 1 1 1 1 9 Li, 2020 0 1 1 1 0 1 1 1 1 1 0 8 Miller, 2020 1 1 1 1 0 1 1 1 1 1 1 10 Nie, 2015 0 1 1 1 0 1 1 1 1 1 0 8 Rao, 2014 0 1 1 1 0 1 1 1 1 1 1 9 Wang, 2015 0 1 1 1 0 1 1 1 1 0 0 7 Wei, 2013 0 1 1 1 0 1 1 1 1 0 0 7 Yajun, 2010 0 1 1 1 0 1 1 1 1 1 1 At one-year, the mean change in the Constant score was 17.0, 17.5, and 19.8, respectively (p=0.34); subscores concerning the range of movement and strength were not significantly different between the groups (p=0.74 and p=0.76, respectively). Patient satisfaction was also not different (p=0.14). The authors concluded that at one-year follow-up, operative treatment is no better than conservative treatment. There was no significant difference in clinical outcome between the interventions at the two-year follow-up. Beard, 2018 313 patients who had subacromial pain for at least 3 months with intact rotator cuff tendons, were eligible for arthroscopic surgery and had previously completed a non-operative management programme that included exercise therapy and at least one steroid injection Placebo surgery (group 1); No intervention (group 2) Mean Oxford Shoulder Score did not differ between the two surgical groups at 6 months (decompression vs arthroscopy (MD -1.3 points, 95% CI -3.9 to 1.3). Both surgical groups showed a small benefit over no treatment, but these differences were not clinically important. There were no differences in complications between the groups. Paavola, 2018 210 patients with symptoms consistent with shoulder impingement syndrome Placebo surgery (group 1); Exercise therapy (group 2) No clinically relevant between-group differences were seen in shoulder pain at rest and on arm activity outcomes at 24 months. No between-group differences were seen between the ASD and diagnostic arthroscopy groups in the secondary outcomes (Constant score, Simple shoulder test score, 15D score, patient satisfaction) or adverse events. The authors concluded that "In this controlled trial involving patients with a shoulder impingement syndrome, arthroscopic subacromial decompression provided no benefit over 24 diagnostic arthroscopy at 24 months. (18) (19) (20) (21) (22) (23) (24) (25) (26) (27) (28) (29) (30) (31) (32) (33) (34) (35) patients with an ACL tear. The strength of the recommendation was moderate. The guidelines indicate limited evidence to support non-surgical management for less active patients with less clinically assessed laxity. Furthermore, when ACL reconstruction is indicated, moderate evidence supports reconstruction within five months of injury to prevent secondary damage to the articular cartilage and menisci. Arthroscopic meniscal repair of the knee Evidence based on mostly observational studies suggests that meniscal repair has better outcomes than meniscectomy. The 2018 British Association for Surgery of the Knee (BASK) Arthroscopic Meniscal Surgery Treatment Guidance was developed to provide an evidence-based national treatment guideline for patients with meniscal lesions of the knee. The Guideline group agreed to four possible treatment recommendations for meniscal lesions: (i) urgent arthroscopic meniscal surgery; (ii) consider arthroscopic meniscal repair; (iii) consider non-urgent arthroscopic partial meniscectomy; and (iv) optimized non-surgical treatment and re-assessment. Arthroscopic meniscal repair was recommended to preserve the meniscus when a reparable target lesion was identified following an acute injury. This decision was to be made by a clinician on a case-by-case basis in careful consultation with the patient. Though the guideline development process was informed by published and unpublished clinical and epidemiological evidence, the recommendations for arthroscopic meniscal repair were based on mostly indirect evidence and low-quality observational studies. The guideline group highlighted this as a priority area for further search. Arthroscopic partial meniscectomy of the knee Evidence based on RCT evidence suggests APM does not show clinically important benefit over non-operative treatment. Consensus statements from specialist knee societies do not recommend APM in patients with knee pain and a meniscal tear, especially in patients with significant or end-stage osteoarthritis. It is only recommended in patients with an 'unstable' pattern of meniscal tear visible on magnetic resonance imaging that corresponds with meniscal ('mechanical') type symptoms and that it should only be performed in patients who have failed a period of non-surgical treatment. Evidence based on RCT evidence showed no clinically important benefits of arthroscopic RCR over nonoperative care. Evidence from AAOS guideline recommendations suggests that physical therapy or operative treatment can be used for the treatment of patients with rotator cuff tears as they both result in significant improvement in patient-reported outcome measures (PROMs). Evidence demonstrates no preferential support for open or arthroscopic repairs, but the arthroscopic-only technique is associated with better short-term improvement in postoperative recovery of motion and decreased VAS scores based on individual RCTs. Arthroscopic subacromial decompression Evidence based on RCT evidence showed no clinically important benefits of subacromial decompression over non-operative care. Guidelines have provided inconsistent recommendations on subacromial decompression surgery for subacromial impingement syndrome, with the majority not making a recommendation for or against the procedure. The British Elbow and Shoulder Society (BESS)/British Orthopaedic Association (BOA) guidelines recommend subacromial decompression surgery in the absence of a rotator cuff tear if impingement symptoms fail to resolve with nonoperative treatment. In a recent Rapid Recommendation published in the British Medical Journal, the guideline panel made a strong recommendation against subacromial decompression surgery in light of recent evidence, including an RCT, which showed no clinically important differences between ASAD and investigational arthroscopy or no treatment for pain and function. In updated guidance published by National Health Service (NHS) England, ASAD is recommended for patients with pure subacromial shoulder impingement who have persistent or progressive symptoms, despite adequate non-operative treatment. Evidence based on RCT evidence showed surgical treatment relieved symptoms significantly better than nonsurgical treatment. The Commissioning Guide for the treatment of CTS developed by the Surgical Speciality Associations and Royal College of Surgeons recommend open or endoscopic decompression of CTS in secondary care for persistent severe symptoms that do not improve with splinting at night, analgesics, and corticosteroid injection for up to 12 weeks. Although no preference was given to either procedure because of the equivocal evidence, it was suggested endoscopic procedures might result in greater patient satisfaction whilst being more costly. It was recommended that open surgery be reserved for elderly patients with multiple comorbidities. Clinical Practice Guidelines developed by the AAOS strongly recommend surgical treatment of CTS compared to nonoperative treatments such as splinting, nonsteroidal antiinflammatory drugs (NSAIDs), and a single steroid injection. There was limited evidence to support endoscopic release over open release based on possible short-term benefits. Lumbar spine decompression Evidence based on RCT evidence showed similar effects for decompression and nonsurgical treatment. The NICE Clinical Guideline recommends that spinal decompression should be considered for people with sciatica when non-surgical treatment has not improved pain or function and their radiological findings are consistent with sciatic symptoms. Lumbar spine fusion Evidence based on RCT evidence showed similar effects for LSF and non-surgical treatment. The NICE Clinical Guideline does not recommend LSF for people with low back pain other than in the context of an RCT due to the lack of evidence of clinical effectiveness. Total hip replacement There are no individual RCTs that have compared THR with non-operative care, no treatment, placebo, or sham surgery for the treatment of end-stage OA. For patients with end-stage osteoarthritis of the hip, both THR and resurfacing arthroplasty are recommended as treatment options only if the prostheses have rates/projected rates of revision of 5% or less at ten years. Guidelines from other bodies such as OARSI and European League Against Rheumatism (EULAR) recommend a hip replacement for patients with radiographic evidence of hip OA who have refractory pain and disability. The evidence for these recommendations is based on head-to-head comparisons between different types of hip prosthesis and uncontrolled studies that have used prosthesis survival as the primary outcome measure. Total knee replacement There are RCTs comparing TKR with no treatment, placebo, or sham surgery for the treatment of end-stage OA. One RCT compared TKR followed by non-surgical treatment versus non-surgical treatment alone (exercise, education, dietary advice, use of insoles, and analgesics) in patients with moderate-tosevere knee OA (published in 2015) The first-line treatment for patients with hip OA is the same as for knee OA, as recommended by NICE Clinical Guideline for Osteoarthritis: care and management. For patients who experience joint symptoms (pain, stiffness, and reduced function) that have a substantial impact on their QoL and are refractory to non-surgical treatment, they recommend joint replacement surgery. Total knee replacement is the preferred surgical option in those with symptomatic OA affecting the entire tibiofemoral joint. Guidelines from other bodies such as OARSI and EULAR also recommend TKR for patients with radiographic evidence of knee OA who have refractory pain and disability. The evidence base for these recommendations is built wholly on observational retrospective studies that have often used prosthesis survival as the primary outcome measure. ACL, anterior cruciate ligament; APM, arthroscopic partial meniscectomy ASAD, arthroscopic subacromial decompression; CTS, carpal tunnel syndrome; LSF, lumbar spine fusion; OA, osteoarthritis; RCT, randomised controlled trial; THR, total hip replacement; TKR, total knee replacement Arthroscopic partial meniscectomy for meniscal tears of the knee: a systematic review and meta-analysis Total disc replacement versus fusion for lumbar degenerative diseases -a metaanalysis of randomized controlled trials Knee arthroscopy versus conservative management in patients with degenerative knee disease: a systematic review Lumbar fusion versus nonoperative management for treatment of discogenic low back pain: a systematic review and meta-analysis of randomized controlled trials Effectiveness and safety of endoscopic versus open carpal tunnel decompression Adverse Event Recording and Reporting in Clinical Trials Comparing Lumbar Disk Replacement with Lumbar Fusion: A Systematic Review Intraindividual comparison between open and endoscopic release in bilateral carpal tunnel syndrome: a meta-analysis of randomized controlled trials Total disc replacement for chronic back pain in the presence of disc degeneration Arthroscopic versus mini-open rotator cuff repair: an up-to-date meta-analysis of randomized controlled trials A systematic review of modern metal-on-metal total hip resurfacing vs standard total hip arthroplasty in active young patients Surgery for rotator cuff tears Subacromial decompression surgery for rotator cuff disease Arthroscopic surgery for degenerative tears of the meniscus: a systematic review and meta-analysis Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials. Spine (Phila Pa Subacromial decompression surgery for adults with shoulder pain: a systematic review with meta-analysis Arthroscopic meniscal surgery versus conservative management in patients aged 40 years and older: a meta-analysis Is minimally invasive superior than open transforaminal lumbar interbody fusion for single-level degenerative lumbar diseases: a meta-analysis The comparison of limited-incision versus standard-incision in treatment of carpal tunnel syndrome: A meta-analysis of randomized controlled trials Interspinous process devices for the treatment of neurogenic intermittent claudication: a systematic review of randomized controlled trials Artificial Total Disc Replacement Versus Fusion for Lumbar Degenerative Disc Disease: An Update Systematic Review and Meta-Analysis Does surgery reduce knee osteoarthritis, meniscal injury and subsequent complications compared with non-surgery after ACL rupture with at least 10 years follow-up? A systematic review and meta-analysis Effectiveness of surgery versus conservative treatment for lumbar spinal stenosis: A system review and meta-analysis of randomized controlled trials Surgical options for lumbar spinal stenosis Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion for Single-Level Degenerative Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials Exercise therapy versus surgery for lumbar spinal stenosis: A systematic review and meta-analysis Surgical versus conservative interventions for treating anterior cruciate ligament injuries The effectiveness of surgical vs conservative interventions on pain and function in patients with shoulder impingement syndrome. A systematic review and meta-analysis Comparison of Total Disc Replacement with lumbar fusion: a meta-analysis of randomized controlled trials Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial Treatment of intrasubstance meniscal lesions: a randomized prospective study of four different methods Four-year follow-up of surgical versus non-surgical therapy for chronic low back pain Lumbar instrumented fusion compared with cognitive intervention and exercises in patients with chronic back pain after previous surgery for disc herniation: a prospective randomized controlled study Treatment for acute anterior cruciate ligament tear: five year outcome of randomised trial A randomized trial of treatment for acute anterior cruciate ligament tears Splinting vs surgery in the treatment of carpal tunnel syndrome: a randomized controlled trial A randomized controlled trial of surgery vs steroid injection for carpal tunnel syndrome Surgery versus non-surgical therapy for carpal tunnel syndrome: a randomised parallel-group trial Surgery versus physical therapy for a meniscal tear and osteoarthritis Exercise therapy versus arthroscopic partial meniscectomy for degenerative meniscal tear in middle aged patients: randomised controlled trial with two year follow-up Treatment of non-traumatic rotator cuff tears: A randomised controlled trial with one-year clinical results Treatment of Nontraumatic Rotator Cuff Tears: A Randomized Controlled Trial with Two Years of Clinical and Imaging Follow-up Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial. Spine (Phila Pa Comparison between surgery and physiotherapy in the treatment of small and medium-sized tears of the rotator cuff: A randomised controlled study of 103 patients with one-year follow-up Tendon repair compared with physiotherapy in the treatment of rotator cuff tears: a randomized controlled study in 103 cases with a five-year follow-up Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: a 5-year follow-up of a randomised, placebo surgery controlled clinical trial Controlled Trial of Total Knee Replacement