de Villiers Cecilia, Goetz Gregor, Sadoghi Patrick, Geiger-Gritsch Sabine
HTA Austria - Austrian Institute for Health Technology Assessment GmbH (Former: Ludwig Boltzmann Institute for Health Technology Assessment), Vienna, Austria.
Department of Orthopaedics and Trauma, Medical University of Graz, Graz, Austria.
Arthrosc Sports Med Rehabil. 2020 Nov 11;2(6):e893-e907. doi: 10.1016/j.asmr.2020.07.017. eCollection 2020 Dec.
To evaluate the evidence of the effectiveness and safety of allografts compared to autografts in posterior cruciate ligament reconstruction.
Four electronic databases were systematically searched for eligible randomized controlled studies. Crucial effectiveness outcomes included patient-reported function, activity level and symptoms, clinical knee stability, health-related quality of life, and patient satisfaction. Safety was evaluated through graft failures, revisions, reruptures and complications. The internal validity of the studies was assessed by the Cochrane risk of bias tool, and the strength of the evidence was judged according to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE).
Two randomized controlled studies were included: 50 patients were analyzed in the allograft group and 58 in the autograft group. No statistically significant postoperative differences were reported between the groups for patient-reported function, activity levels or symptoms. One study reported a statistically significant difference in instrumented postoperative anteroposterior knee laxity favoring stability in autografts. This difference is, however, not relevant in the clinical setting. Insufficient evidence was found to judge safety outcomes and because complications were poorly measured, and none of the studies reported on graft failure, revision or rerupture rates. The studies were judged with unclear to high risk of bias. The strength of the evidence for effectiveness and safety was judged to be low to very low, according to GRADE.
Allografts may be comparable to autografts for crucial effectiveness outcomes, but insufficient evidence was found to judge crucial safety outcomes due to poor reporting of safety measures and outcomes. Results should be interpreted with caution because there is lack of good-quality evidence to support the superiority of allografts over autografts due to the high risk of bias in the primary studies and overall very low strength of the body of evidence according to GRADE.
Systematic review of Level II studies.
评估在重建后交叉韧带时，同种异体移植物与自体移植物相比有效性和安全性的证据。
系统检索四个电子数据库，以查找符合条件的随机对照研究。关键有效性结果包括患者报告的功能、活动水平和症状、临床膝关节稳定性、健康相关生活质量以及患者满意度。通过移植物失败、翻修、再断裂和并发症来评估安全性。采用Cochrane偏倚风险工具评估研究的内部有效性，并根据推荐分级、评估、制定与评价（GRADE）来判断证据的强度。
纳入两项随机对照研究：同种异体移植物组分析了50例患者，自体移植物组分析了58例患者。两组在患者报告的功能、活动水平或症状方面，术后未报告有统计学显著差异。一项研究报告称，术后仪器测量的膝关节前后向松弛度存在统计学显著差异，自体移植物更有利于稳定性。然而，这种差异在临床环境中并不相关。未找到足够证据来判断安全性结果，且由于并发症测量不佳，没有研究报告移植物失败、翻修或再断裂率。这些研究被判定为偏倚风险不明确至高风险。根据GRADE，有效性和安全性证据的强度被判定为低至极低。
对于关键有效性结果，同种异体移植物可能与自体移植物相当，但由于安全性措施和结果报告不佳，未找到足够证据来判断关键安全性结果。结果应谨慎解读，因为由于原始研究中存在高偏倚风险，且根据GRADE总体证据强度极低，缺乏高质量证据支持同种异体移植物优于自体移植物。
II级研究的系统评价。
