Oxford Trauma and Emergency Care, Nuffield Department of Orthopaedic Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Oxford University Clinical Academic Graduate School, University of Oxford, John Radcliffe Hospital, Oxford, UK.
Cochrane Database Syst Rev. 2022 Oct 5;10(10):CD010606. doi: 10.1002/14651858.CD010606.pub3.
Fractures of the distal femur (the far end of the thigh bone just above the knee) are a considerable cause of morbidity. Various different surgical and non-surgical treatments have been used in the management of these injuries but the best treatment remains unknown.
To evaluate the benefits and harms of interventions for treating fractures of the distal femur in adults.
We used standard, extensive Cochrane search methods. The latest search date was October 2021.
We included randomised and quasi-randomised controlled trials in adults comparing interventions for treating fractures of the distal femur. Interventions included surgical implants (retrograde intramedullary nail (RIMN), fixed-angle devices, non-locking plate fixation, locking plate, internal fixation, distal femoral replacement, mono-axial plates, poly-axial plates and condylar buttress plates) and non-surgical management.
We used standard Cochrane methods. Our critical outcomes were validated patient-reported outcome measures (PROMs), direct adverse events, participant-reported quality of life (QoL) and pain scores. Our other important outcomes were adverse events indirectly related to intervention, symptomatic non-union, malunion and resource use. We used GRADE to assess certainty of evidence for each outcome.
We included 14 studies with 753 participants: 13 studies compared different surgical interventions, and one study compared surgical with non-surgical management. Here, we report the effects for RIMN compared with locking plates. Three studies (221 participants) reported this comparison; it included the largest study population and these are the two most commonly used devices in contemporary orthopaedic trauma practice. Studies used three different tools to assess PROMs. We found very-low certainty evidence for lower Disability Rating Index scores after RIMN at short-term follow-up favouring RIMN (mean difference (MD) -21.90, 95% confidence interval (CI) -38.16 to -5.64; 1 study, 12 participants) and low-certainty evidence of little or no difference at long-term follow-up (standardised mean difference (SMD) -0.22, 95% CI -0.50 to 0.06; 2 studies, 198 participants). Re-expressing the SMD of the long-term follow-up data to Knee Society Score (KSS) used by one study found no clinical benefit of RIMN, based on a minimal clinically important difference of 9 points (MD 2.47, 95% CI -6.18 to 0.74). The effect on QoL was very uncertain at four months (MD 0.01, 95% CI -0.42 to 0.44; 1 study, 14 participants) and one year (MD 0.10, 95% CI -0.01 to 0.21; 1 study, 156 participants); this evidence was very low certainty. For direct adverse events, studies reported reoperation, loss of fixation, superficial and deep infection, haematoma formation and implant loosening. Effects for all events were imprecise with the possibility of benefit or harm for both treatments. We considered reoperation the most clinically relevant. There was very low-certainty evidence of little or no difference in reoperation between the two implants (risk ratio (RR) 1.48, 95% CI 0.55 to 4.00; 1 study, 104 participants). No studies reported pain. For other important outcomes, we noted that people treated with RIMN may be more likely to have varus/valgus deformity (RR 2.18, 95% CI 1.09 to 4.37; 1 study, 33 participants; low-certainty evidence). However, we found no evidence of any important differences between treatments in terms of bony union, indirect adverse events, or resource use. Other comparisons of surgical interventions included in the review were: RIMN versus single fixed-angle device (3 studies, 175 participants); RIMN versus non-locking plate fixation (1 study, 18 participants); locking plate versus single fixed-angle device (2 studies, 130 participants); internal fixation versus distal femoral replacement (1 study, 23 participants); mono-axial plates versus poly-axial plates (2 studies, 67 participants); mono-axial plate versus condylar buttress plate (1 study, 78 participants). The certainty of the evidence for outcomes in these comparisons was low to very low, and most effect estimates were imprecise.
AUTHORS' CONCLUSIONS: This review highlights the major limitations of the available evidence concerning current treatment interventions for fractures of the distal femur. The currently available evidence is incomplete and insufficient to inform clinical practice. Priority should be given to randomised controlled trials comparing contemporary treatments for people with fractures of the distal femur. At a minimum, these should report validated patient-reported functional and quality-of-life outcomes at one and two years, with an agreed core outcome set. All trials should be reported in full using the CONSORT guidelines.
股骨远端骨折(大腿骨靠近膝盖的末端)是导致发病率较高的一个重要原因。各种不同的手术和非手术治疗方法已被用于治疗这些损伤,但最佳治疗方法仍不清楚。
评估治疗成人股骨远端骨折的干预措施的益处和危害。
我们使用了标准的、广泛的 Cochrane 检索方法。最新的检索日期是 2021 年 10 月。
我们纳入了比较治疗股骨远端骨折的手术和非手术干预措施的随机和准随机对照试验。干预措施包括外科植入物(逆行髓内钉(RIMN)、固定角度装置、非锁定板固定、锁定板、内固定、股骨远端置换、单轴钢板、多轴钢板和髁突支撑钢板)和非手术治疗。
我们使用了标准的 Cochrane 方法。我们的关键结局是验证患者报告的结局测量(PROMs)、直接不良事件、参与者报告的生活质量(QoL)和疼痛评分。我们的其他重要结局是与干预相关的间接不良事件、症状性非愈合、畸形愈合和资源使用。我们使用 GRADE 评估每个结局的证据确定性。
我们纳入了 14 项研究,共 753 名参与者:13 项研究比较了不同的手术干预措施,1 项研究比较了手术与非手术治疗。在这里,我们报告了 RIMN 与锁定板的比较结果。三项研究(221 名参与者)报告了这一比较;这是最大的研究人群,也是当代骨科创伤实践中最常用的两种设备。研究使用了三种不同的工具来评估 PROMs。我们发现,在短期随访中,RIMN 的残疾评定指数(Disability Rating Index)评分较低,这具有非常低的确定性证据,表明 RIMN 有优势(平均差值(MD)-21.90,95%置信区间(CI)-38.16 至-5.64;1 项研究,12 名参与者),而在长期随访中,差异较小或无差异,这具有低确定性证据(标准化均数差值(SMD)-0.22,95%CI-0.50 至 0.06;2 项研究,198 名参与者)。将长期随访数据的 SMD 重新表示为一项研究使用的膝关节协会评分(Knee Society Score,KSS),发现 RIMN 没有临床获益,基于 9 分的最小临床重要差异(MD 2.47,95%CI-6.18 至 0.74)。在四个月(MD 0.01,95%CI-0.42 至 0.44;1 项研究,14 名参与者)和一年(MD 0.10,95%CI-0.01 至 0.21;1 项研究,156 名参与者)时,对 QoL 的影响非常不确定;这一证据的确定性非常低。对于直接不良事件,研究报告了再次手术、固定丢失、浅表和深部感染、血肿形成和植入物松动。所有事件的效果都不精确,两种治疗方法都有可能出现获益或危害。我们认为再次手术是最具临床相关性的。两种植入物之间再次手术的可能性差异较小或无差异,这具有非常低的确定性证据(风险比(RR)1.48,95%CI 0.55 至 4.00;1 项研究,104 名参与者)。没有研究报告疼痛。对于其他重要结局,我们注意到,接受 RIMN 治疗的人可能更容易出现内翻/外翻畸形(RR 2.18,95%CI 1.09 至 4.37;1 项研究,33 名参与者;低确定性证据)。然而,我们没有发现两种治疗方法在骨愈合、间接不良事件或资源使用方面有任何重要差异。该综述中包括的其他手术干预措施的比较包括:RIMN 与单固定角度装置(3 项研究,175 名参与者);RIMN 与非锁定板固定(1 项研究,18 名参与者);锁定板与单固定角度装置(2 项研究,130 名参与者);内固定与股骨远端置换(1 项研究,23 名参与者);单轴钢板与多轴钢板(2 项研究,67 名参与者);单轴钢板与髁突支撑钢板(1 项研究,78 名参与者)。这些比较的结局的证据确定性为低至非常低,并且大多数效应估计值都不精确。
本综述突出了目前治疗股骨远端骨折的干预措施相关证据的主要局限性。目前的证据不完整,不足以为临床实践提供信息。应优先考虑对股骨远端骨折患者进行比较现代治疗方法的随机对照试验。这些试验至少应报告一年和两年的患者报告的功能和生活质量结局,且有一个公认的核心结局集。所有试验都应按照 CONSORT 指南进行完整报告。