Hofstede Stefanie N, Nouta Klaas Auke, Jacobs Wilco, van Hooff Miranda L, Wymenga Ate B, Pijls Bart G, Nelissen Rob G H H, Marang-van de Mheen Perla J
Department of Medical Decision Making, Leiden University Medical Center, Postzone J10-s, room J10-88, P.O. Box 9600, Leiden, Netherlands, 2300 RC.
Cochrane Database Syst Rev. 2015 Feb 4;2015(2):CD003130. doi: 10.1002/14651858.CD003130.pub3.
BACKGROUND: It is unclear whether there are differences in benefits and harms between mobile and fixed prostheses for total knee arthroplasty (TKA). The previous Cochrane review published in 2004 included two articles. Many more trials have been performed since then; therefore an update is needed. OBJECTIVES: To assess the benefits and harms of mobile bearing compared with fixed bearing cruciate retaining total knee arthroplasty for functional and clinical outcomes in patients with osteoarthritis (OA) or rheumatoid arthritis (RA). SEARCH METHODS: We searched The Cochrane Library, PubMed, EMBASE, CINAHL and Web of Science up to 27 February 2014, and the trial registers ClinicalTrials.gov, Multiregister, Current Controlled Trials and the World Health Organization (WHO) International Clinical Trials Registry Platform for data from unpublished trials, up to 11 February 2014. We also screened the reference lists of selected articles. SELECTION CRITERIA: We selected randomised controlled trials comparing mobile bearing with fixed bearing prostheses in cruciate retaining TKA among patients with osteoarthritis or rheumatoid arthritis, using functional or clinical outcome measures and follow-up of at least six months. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures as expected by The Cochrane Collaboration. MAIN RESULTS: We found 19 studies with 1641 participants (1616 with OA (98.5%) and 25 with RA (1.5%)) and 2247 knees. Seventeen new studies were included in this update.Quality of the evidence ranged from moderate (knee pain) to low (other outcomes). Most studies had unclear risk of bias for allocation concealment, blinding of participants and personnel, blinding of outcome assessment and selective reporting, and high risk of bias for incomplete outcome data and other bias. Knee painWe calculated the standardised mean difference (SMD) for pain, using the Knee Society Score (KSS) and visual analogue scale (VAS) in 11 studies (58%) and 1531 knees (68%). No statistically significant differences between groups were reported (SMD 0.09, 95% confidence interval (CI) -0.03 to 0.22, P value 0.15). This represents an absolute risk difference of 2.4% points higher (95% CI 0.8% lower to 5.9% higher) on the KSS pain scale and a relative percent change of 0.22% (95% CI 0.07% lower to 0.53% higher). The results were homogeneous. Clinical and functional scores The KSS clinical score did not differ statistically significantly between groups (14 studies (74%) and 1845 knees (82%)) with a mean difference (MD) of -1.06 points (95% CI -2.87 to 0.74, P value 0.25) and heterogeneous results. KSS function was reported in 14 studies (74%) with 1845 knees (82%) as an MD of -0.10 point (95% CI -1.93 to 1.73, P value 0.91) and homogeneous results. In two studies (11%), the KSS total score was favourable for mobile bearing (159 vs 132 for fixed bearing), with MD of -26.52 points (95% CI -45.03 to -8.01, P value 0.005), but with a wide 95% confidence interval indicating uncertainty about the estimate.Other reported scoring systems did not show statistically significant differences: Hospital for Special Surgery (HSS) score (seven studies (37%) in 1021 knees (45%)) with an MD of -1.36 (95% CI -4.18 to 1.46, P value 0.35); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score (two studies (11%), 167 knees (7%)) with an MD of -4.46 (95% CI -16.26 to 7.34, P value 0.46); and Oxford total (five studies (26%), 647 knees (29%) with an MD of -0.25 (95% CI -1.41 to 0.91, P value 0.67). Health-related quality of lifeThree studies (16%) with 498 knees (22%) reported on health-related quality of life, and no statistically significant differences were noted between the mobile bearing and fixed bearing groups. The Short Form (SF)-12 Physical Component Summary had an MD of -1.96 (95% CI -4.55 to 0.63, P value 0.14) and heterogeneous results. Revision surgeryTwenty seven revisions (1.3%) were performed in 17 studies (89%) with 2065 knees (92%). In all, 13 knees were revised in the fixed bearing group and 14 knees in the mobile bearing group. No statistically significant differences were found (risk difference 0.00, 95% CI -0.01 to 0.01, P value 0.58), and homogeneous results were reported. MortalityIn seven out of 19 studies, 13 participants (37%) died. Two of these participants had undergone bilateral surgery, and for seven participants, it was unclear which prosthesis they had received; therefore they were excluded from the analyses. Thus our analysis included four out of 191 participants (2.1%) who had died: one in the fixed bearing group and three in the mobile bearing group. No statistically significant differences were found. The risk difference was -0.02 (95% CI -0.06 to 0.03, P value 0.49) and results were homogeneous. Reoperation ratesThirty reoperations were performed in 17 studies (89%) with 2065 knees (92%): 18 knees in the fixed bearing group (of the 1031 knees) and 12 knees in the mobile group (of the 1034 knees). No statistically significant differences were found. The risk difference was -0.01 (95% CI -0.01 to 0.01, P value 0.99) with homogeneous results. Other serious adverse eventsSixteen studies (84%) reported nine other serious adverse events in 1735 knees (77%): four in the fixed bearing group (of the 862 knees) and five in the mobile bearing group (of the 873 knees). No statistically significant differences were found (risk difference 0.00, 95% CI -0.01 to 0.01, P value 0.88), and results were homogeneous. AUTHORS' CONCLUSIONS: Moderate- to low-quality evidence suggests that mobile bearing prostheses may have similar effects on knee pain, clinical and functional scores, health-related quality of life, revision surgery, mortality, reoperation rate and other serious adverse events compared with fixed bearing prostheses in posterior cruciate retaining TKA. Therefore we cannot draw firm conclusions. Most (98.5%) participants had OA, so the findings primarily reflect results reported in participants with OA. Future studies should report in greater detail outcomes such as those presented in this systematic review, with sufficient follow-up time to allow gathering of high-quality evidence and to inform clinical practice. Large registry-based studies may have added value, but they are subject to treatment-by-indication bias. Therefore, this systematic review of RCTs can be viewed as the best available evidence.
背景:全膝关节置换术(TKA)中,活动式与固定式假体在益处和危害方面是否存在差异尚不清楚。2004年发表的Cochrane综述纳入了两篇文章。自那时起进行了更多试验,因此需要更新。 目的:评估活动轴承与固定轴承交叉韧带保留全膝关节置换术相比,对骨关节炎(OA)或类风湿关节炎(RA)患者功能和临床结局的益处和危害。 检索方法:我们检索了截至2014年2月27日的Cochrane图书馆、PubMed、EMBASE、CINAHL和科学引文索引数据库,并检索了试验注册库ClinicalTrials.gov、Multiregister、当前对照试验和世界卫生组织(WHO)国际临床试验注册平台,以获取截至2014年2月11日未发表试验的数据。我们还筛选了所选文章的参考文献列表。 选择标准:我们选择了随机对照试验,比较骨关节炎或类风湿关节炎患者在交叉韧带保留TKA中活动轴承与固定轴承假体的情况,使用功能或临床结局指标,并进行至少六个月的随访。 数据收集与分析:我们采用了Cochrane协作网预期的标准方法程序。 主要结果:我们找到19项研究,涉及1641名参与者(1616名OA患者(98.5%)和25名RA患者(1.5%))以及2247个膝关节。本次更新纳入了17项新研究。证据质量从中等(膝关节疼痛)到低(其他结局)不等。大多数研究在分配隐藏、参与者和人员的盲法、结局评估的盲法和选择性报告方面的偏倚风险不明确,在不完整结局数据和其他偏倚方面的偏倚风险高。膝关节疼痛:我们使用膝关节协会评分(KSS)和视觉模拟量表(VAS)在11项研究(58%)和1531个膝关节(68%)中计算了疼痛的标准化均值差(SMD)。未报告组间有统计学显著差异(SMD 0.09,95%置信区间(CI)-0.03至0.22,P值0.15)。这代表在KSS疼痛量表上绝对风险差高2.4个百分点(95%CI低0.8%至高5.9%),相对百分比变化为0.22%(95%CI低0.07%至高0.53%)。结果具有同质性。临床和功能评分:在14项研究(74%)和1845个膝关节(82%)中,KSS临床评分组间无统计学显著差异,平均差(MD)为-1.
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