Palmer Jonathan S, Monk A Paul, Hopewell Sally, Bayliss Lee E, Jackson William, Beard David J, Price Andrew J
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Windmill Road, Headington, Oxford, UK, OX3 7LD.
Cochrane Database Syst Rev. 2019 Jul 19;7(7):CD012128. doi: 10.1002/14651858.CD012128.pub2.
Osteoarthritis affecting the knee is common and represents a continuum of disease from early cartilage thinning to full-thickness cartilage loss, bony erosion, and deformity. Many studies do not stratify their results based on the severity of the disease at baseline or recruitment.
To assess the benefits and harms of surgical intervention for the management of symptomatic mild to moderate knee osteoarthritis defined as knee pain and radiographic evidence of non-end stage osteoarthritis (Kellgren-Lawrence grade 1, 2, 3 or equivalent on MRI/arthroscopy). Outcomes of interest included pain, function, radiographic progression, quality of life, short-term serious adverse events, re-operation rates and withdrawals due to adverse events.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase up to May 2018. We also conducted searches of ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform for ongoing trials. Authors of trials were contacted if some but not all their participants appeared to fit our inclusion criteria.
We included randomised controlled trials that compared surgery to non-surgical interventions (including sham and placebo control groups, exercise or physiotherapy, and analgesic or other medication), injectable therapies, and trials that compared one type of surgical intervention to another surgical intervention in people with symptomatic mild to moderate knee osteoarthritis.
Two review authors independently selected trials and extracted data using standardised forms. We analysed the quality of evidence using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach.
A total of five studies involving 566 participants were identified as eligible for this review. Single studies compared arthroscopic partial meniscectomy to physical therapy (320 participants), arthroscopic surgery (debridement ± synovectomy ± chondroplasty) to closed needle joint lavage with saline (32 participants) and high tibial osteotomy surgery to knee joint distraction surgery (62 participants). Two studies (152 participants) compared arthroscopic surgery (washout ± debridement; debridement) to a hyaluronic acid injection. Only one study was at low risk of selection bias, and due to the difficulty of blinding participants to their treatment, all studies were at risk of performance and detection bias.Reporting of results in this summary has been restricted to the primary comparison: surgical intervention versus non-surgical intervention.A single study, included 320 participants with symptoms consistent with meniscal tear. All subjects had the meniscal tear confirmed on knee MRI and radiographic evidence of mild to moderate osteoarthritis (osteophytes, cartilage defect or joint space narrowing). Patients with severe osteoarthritis (KL grade 4) were excluded. The study compared arthroscopic partial meniscectomy and physical therapy to physical therapy alone (a six-week individualised progressive home exercise program). This study was at low risk of selection bias and outcome reporting biases, but was susceptible to performance and detection biases. A high rate of cross-over (30.2%) occurred from the physical therapy group to the arthroscopic group.Low-quality evidence suggests there may be little difference in pain and function at 12 months follow-up in people who have arthroscopic partial meniscectomy and those who have physical therapy. Evidence was downgraded to low quality due to risk of bias and imprecision.Mean pain was 19.3 points on a 0 to 100 point KOOS pain scale with physical therapy at 12 months follow-up and was 0.2 points better with surgery (95% confidence interval (CI) 4.05 better to 3.65 points worse with surgery, an absolute improvement of 0.2% (95% CI 4% better to 4% worse) and relative improvement 0.4% (95% CI 9% better to 8% worse) (low quality evidence). Mean function was 14.5 on a 0 to 100 point KOOS function scale with physical therapy at 12 months follow-up and 0.8 points better with surgery (95% CI 4.3 better to 2.7 worse); 0.8% absolute improvement (95% CI 4% better to 3% worse) and 2.1% relative improvement (95% CI 11% better to 7% worse) (low quality evidence).Radiographic structural osteoarthritis progression and quality of life outcomes were not reported.Due to very low quality evidence, we are uncertain if surgery is associated with an increased risk of serious adverse events, incidence of total knee replacement or withdrawal rates. Evidence was downgraded twice due to very low event rates, and once for risk of bias.At 12 months, the surgery group had a total of three serious adverse events including fatal pulmonary embolism, myocardial infarction and hypoxaemia. The physical therapy alone group had two serious adverse events including sudden death and stroke (Peto OR 1.58, 95% CI 0.27 to 9.21); 1% more events with surgery (95% CI 2% less to 3% more) and 58% relative change (95% CI 73% less to 821% more). One participant in each group withdrew due to adverse events.Two of 164 participants (1.2%) in the physical therapy group and three of 156 in the surgery group underwent conversion to total knee replacement within 12 months (Peto OR 1.76, 95% CI 0.43 to 7.13); 1% more events with surgery (95% CI 2% less to 5% more); 76% relative change (95% CI 57% less to 613% more).
AUTHORS' CONCLUSIONS: The review found no placebo-or sham-controlled trials of surgery in participants with symptomatic mild to moderate knee osteoarthritis. There was low quality evidence that there may be no evidence of a difference between arthroscopic partial meniscectomy surgery and a home exercise program for the treatment of this condition. Similarly, low-quality evidence from a few small trials indicates there may not be any benefit of arthroscopic surgery over other non-surgical treatments including saline irrigation and hyaluronic acid injection, or one type of surgery over another. We are uncertain of the risk of adverse events or of progressing to total knee replacement due to very small event rates. Thus, there is uncertainty around the current evidence to support or oppose the use of surgery in mild to moderate knee osteoarthritis. As no benefit has been demonstrated from the low quality trials included in this review, it is possible that future higher quality trials for these surgical interventions may not contradict these results.
膝关节骨关节炎很常见,代表了从早期软骨变薄到全层软骨丢失、骨侵蚀和畸形的一系列疾病。许多研究并未根据基线或入组时疾病的严重程度对结果进行分层。
评估手术干预对有症状的轻至中度膝关节骨关节炎(定义为膝关节疼痛及非终末期骨关节炎的影像学证据,即MRI/关节镜检查显示Kellgren-Lawrence分级为1、2、3级或相当情况)的益处和危害。感兴趣的结局包括疼痛、功能、影像学进展、生活质量、短期严重不良事件、再次手术率以及因不良事件导致的退出率。
我们检索了截至2018年5月的Cochrane对照试验中心注册库(CENTRAL)、MEDLINE和Embase。我们还检索了ClinicalTrials.gov和世界卫生组织国际临床试验注册平台以查找正在进行的试验。如果试验的部分但并非所有参与者似乎符合我们的纳入标准,我们会联系试验的作者。
我们纳入了随机对照试验,这些试验比较了手术与非手术干预(包括假手术和安慰剂对照组、运动或物理治疗、止痛或其他药物)、注射疗法,以及比较一种手术干预与另一种手术干预在有症状的轻至中度膝关节骨关节炎患者中的试验。
两位综述作者独立选择试验并使用标准化表格提取数据。我们使用GRADE(推荐分级、评估、制定和评价)方法分析证据质量。
共识别出五项涉及566名参与者的研究符合本综述的纳入标准。单项研究比较了关节镜下部分半月板切除术与物理治疗(320名参与者)、关节镜手术(清创±滑膜切除术±软骨成形术)与生理盐水封闭针关节灌洗(32名参与者)以及高位胫骨截骨术与膝关节撑开手术(62名参与者)。两项研究(152名参与者)比较了关节镜手术(冲洗±清创;清创)与透明质酸注射。只有一项研究存在低选择偏倚风险,并且由于难以使参与者对其治疗不知情,所有研究均存在实施和检测偏倚风险。本综述的结果报告仅限于主要比较:手术干预与非手术干预。一项纳入320名有半月板撕裂症状参与者的研究。所有受试者经膝关节MRI证实有半月板撕裂且有轻至中度骨关节炎的影像学证据(骨赘、软骨缺损或关节间隙变窄)。排除了重度骨关节炎(KL 4级)患者。该研究比较了关节镜下部分半月板切除术联合物理治疗与单纯物理治疗(为期六周的个体化渐进性家庭锻炼计划)。该研究存在低选择偏倚和结局报告偏倚风险,但易受实施和检测偏倚影响。从物理治疗组交叉至关节镜组的发生率较高(30.2%)。低质量证据表明,在12个月随访时,接受关节镜下部分半月板切除术的人与接受物理治疗的人在疼痛和功能方面可能差异不大。由于存在偏倚风险和不精确性,证据质量被降为低质量。在12个月随访时,单纯物理治疗组在0至100分的KOOS疼痛量表上的平均疼痛评分为19.3分[1],手术组比其好0.2分(95%置信区间(CI):手术组比其好4.05分至差3.65分,绝对改善0.2%(95%CI:好4%至差4%);相对改善0.4%(95%CI:好9%至差8%)(低质量证据)。在12个月随访时,单纯物理治疗组在0至100分的KOOS功能量表上的平均功能评分为14.5分,手术组比其好0.8分(95%CI:好4.3分至差2.7分);绝对改善0.8%(95%CI:好4%至差3%);相对改善2.1%(95%CI:好11%至差7%)(低质量证据)。未报告影像学结构性骨关节炎进展和生活质量结局。由于证据质量极低[2],我们不确定手术是否与严重不良事件风险增加、全膝关节置换发生率或退出率有关。由于事件发生率极低,证据质量被降两级,因偏倚风险降一级。在12个月时,手术组共有三例严重不良事件,包括致命性肺栓塞、心肌梗死和低氧血症。单纯物理治疗组有两例严重不良事件,包括猝死和中风(Peto比值比1.58,95%CI:0.27至9.21);手术组事件多1%(95%CI:少2%至多3%);相对变化58%(95%CI:少73%至多821%)。每组各有一名参与者因不良事件退出。物理治疗组164名参与者中有2名(1.2%)和手术组156名参与者中有3名在12个月内接受了全膝关节置换转换手术(Peto比值比1.76,95%CI:0.43至7.13);手术组事件多1%(95%CI:少2%至多5%);相对变化76%(95%CI:少57%至多613%)。
本综述未发现针对有症状的轻至中度膝关节骨关节炎患者进行手术的安慰剂或假手术对照试验。低质量证据表明,关节镜下部分半月板切除术与家庭锻炼计划在治疗这种疾病方面可能没有差异。同样,少数小型试验的低质量证据表明,关节镜手术相对于包括生理盐水冲洗和透明质酸注射在内的其他非手术治疗可能没有任何益处,一种手术相对于另一种手术也可能没有益处。由于事件发生率极低,我们不确定不良事件风险或进展至全膝关节置换的风险。因此,目前支持或反对在轻至中度膝关节骨关节炎中使用手术的证据存在不确定性。由于本综述纳入的低质量试验未证明有任何益处,未来针对这些手术干预的更高质量试验可能不会与这些结果相矛盾。