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用于个性化移植物选择并降低前交叉韧带重建破裂率的风险计算器的验证

Validation of a Risk Calculator to Personalize Graft Choice and Reduce Rupture Rates for Anterior Cruciate Ligament Reconstruction.

作者信息

Marmura Hana, Getgood Alan M J, Spindler Kurt P, Kattan Michael W, Briskin Isaac, Bryant Dianne M

机构信息

Faculty of Health Sciences, Western University, London, Ontario, Canada.

Fowler Kennedy Sport Medicine Clinic, London, Ontario, Canada.

出版信息

Am J Sports Med. 2021 Jun;49(7):1777-1785. doi: 10.1177/03635465211010798. Epub 2021 May 4.

Abstract

BACKGROUND

Anterior cruciate ligament reconstructions (ACLRs) fail at an alarmingly high rate in young active individuals. The Multicenter Orthopaedic Outcomes Network (MOON) knee group has developed an autograft risk calculator that uses patient characteristics and lifestyle to predict the probability of graft rupture if the surgeon uses a hamstring tendon (HT) or a bone-patellar tendon-bone (BPTB) graft to reconstruct the ligament. If validated, this risk calculator can be used during the shared decision-making process to make optimal ACLR autograft choices and reduce rupture rates. The STABILITY 1 randomized clinical trial offers a large, rigorously collected data set of similar young active patients who received HT autograft with or without lateral extra-articular tenodesis (LET) for ACLR.

PURPOSE/HYPOTHESIS: The purpose was to validate the ACLR graft rupture risk calculator in a large external data set and to investigate the utility of BPTB and LET for ACLR. We hypothesized that the risk calculator would maintain adequate discriminative ability and calibration in the external STABILITY 1 data set when compared with the initial MOON development data set.

STUDY DESIGN

Cohort study (diagnosis); Level of evidence, 1.

METHODS

The model predictors for the risk calculator include age, sex, body mass index, sport played at the time of injury, Marx Activity Score, preoperative knee laxity, and graft type. The STABILITY 1 trial data set was used for external validation. Discriminative ability, calibration, and diagnostic test validity of the model were assessed. Finally, predictor strength in the initial and validation samples was compared.

RESULTS

The model showed acceptable discriminative ability (area under the curve = 0.73), calibration (Brier score = 0.07), and specificity (85.3%) to detect patients who will experience a graft rupture. Age, high-grade preoperative knee laxity, and graft type were significant predictors of graft rupture in young active patients. BPTB and the addition of LET to HT were protective against graft rupture versus HT autograft alone.

CONCLUSION

The MOON risk calculator is a valid predictor of ACLR graft rupture and is appropriate for clinical practice. This study provides evidence supporting the idea that isolated HT autografts should be avoided for young active patients undergoing ACLR.

REGISTRATION

NCT00463099 (MOON); NCT02018354 (STABILITY 1) (ClinicalTrials.gov identifiers).

摘要

背景

在年轻的活跃个体中,前交叉韧带重建术(ACLR)失败率高得惊人。多中心骨科结局网络(MOON)膝关节研究小组开发了一种自体移植物风险计算器,该计算器利用患者特征和生活方式来预测,如果外科医生使用腘绳肌腱(HT)或骨-髌腱-骨(BPTB)移植物重建韧带,移植物破裂的概率。如果得到验证,这种风险计算器可在共同决策过程中用于做出最佳的ACLR自体移植物选择,并降低破裂率。STABILITY 1随机临床试验提供了一个大型、严格收集的类似年轻活跃患者的数据集,这些患者接受了HT自体移植物,用于ACLR,有的还进行了外侧关节外肌腱固定术(LET)。

目的/假设:目的是在一个大型外部数据集中验证ACLR移植物破裂风险计算器,并研究BPTB和LET在ACLR中的效用。我们假设,与最初的MOON开发数据集相比,风险计算器在外部STABILITY 1数据集中将保持足够的区分能力和校准。

研究设计

队列研究(诊断);证据等级,1级。

方法

风险计算器的模型预测因素包括年龄、性别、体重指数、受伤时进行的运动、马克思活动评分、术前膝关节松弛度和移植物类型。STABILITY 1试验数据集用于外部验证。评估了模型的区分能力、校准和诊断测试有效性。最后,比较了初始样本和验证样本中的预测因素强度。

结果

该模型显示出可接受的区分能力(曲线下面积 = 0.73)、校准(Brier评分 = 0.07)和特异性(85.3%),以检测将经历移植物破裂的患者。年龄、术前高度膝关节松弛度和移植物类型是年轻活跃患者移植物破裂的重要预测因素。与单独使用HT自体移植物相比,BPTB以及在HT基础上加用LET可预防移植物破裂。

结论

MOON风险计算器是ACLR移植物破裂的有效预测指标,适用于临床实践。本研究提供了证据支持这样的观点,即对于接受ACLR的年轻活跃患者,应避免单独使用HT自体移植物。

注册信息

NCT00463099(MOON);NCT02018354(STABILITY 1)(ClinicalTrials.gov标识符)

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