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使用超临界二氧化碳灭菌同种异体移植物进行前交叉韧带重建的结果。

Outcomes of ACL Reconstruction Utilizing Supercritical CO-Sterilized Allografts.

作者信息

Farey John E, Salmon Lucy J, Roe Justin P, Russell Vivianne, Sundaraj Keran, Pinczewski Leo A

机构信息

North Sydney Orthopaedic and Sports Medicine Centre, Mater Clinic, Wollstonecraft, New South Wales, Australia.

School of Medicine, University of Notre Dame Australia, Sydney, New South Wales, Australia.

出版信息

Orthop J Sports Med. 2024 Aug 9;12(8):23259671241254115. doi: 10.1177/23259671241254115. eCollection 2024 Aug.

DOI:10.1177/23259671241254115
PMID:39135859
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11318055/
Abstract

BACKGROUND

Allograft tendons are perceived to have a high ACL graft failure rate in primary anterior cruciate ligament (ACL) reconstruction (ACLR). Historical series may be biased by graft processing methods that degrade the biomechanical properties of donor tendons such as irradiation. Supercritical carbon dioxide (SCCO) is a validated method of terminally sterilizing biomaterials at physiological temperatures without irradiation, but in vivo use of SCCO-processed tendon allografts for primary ACLR has not been reported to date.

HYPOTHESIS

ACLR with SCCO allografts would result in acceptable failure rates, subjective knee scores, and clinical evaluation at 2 years postoperatively.

STUDY DESIGN

Case series; Level of evidence, 4.

METHODS

Patients underwent primary ACLR with terminally sterilized SCCO-processed human gracilis, peroneus longus, semitendinosus, tibialis anterior, and tibialis posterior tendon allografts. Patient demographics were collected, along with tendon donor age and sex. At 1 year postoperatively, subjective International Knee Documentation Committee (IKDC) and ACL-Return to Sport After Injury (ACL-RSI) scores were collected, as well as clinical evaluation. At 2 years postoperatively, the IKDC and ACL-RSI scores were repeated, and return to sports and further knee injuries were recorded.

RESULTS

A total of 144 patients with a medianage of 26 (IQR 14) years formed the study group. Patients were predominately male (58%). The loss to follow-up rate was 8% (n = 12). The mean age of allograft tendon donors was 37 (range 17-58) years, and the majority were male (83%). The mean allograft diameter was 8.9 ± 1.0 mm. At 2 years, ACL graft failureoccurred in 5% (n = 7). All graft failureswere in patients aged ≤25 years ( = .007). Neither donor age (≤40 or >40 years) nor donor sex was associated with graft failure ( > .05). The median IKDC subjective score was 95 and ACL-RSI score was 75. There were no revisions for sepsis within the first 2 years postoperatively.

CONCLUSION

SCCO processing of allograft tendons demonstrated satisfactory clinical and patient-reported outcomes at 24 months postoperatively in a consecutive series of patients with primary ACLR, with similar ACL graft failure rates and subjective knee scores compared with those reported in published series of hamstring tendon autograft and fresh frozen nonirradiated allograft.

摘要

背景

在初次前交叉韧带(ACL)重建术(ACLR)中,同种异体肌腱被认为具有较高的ACL移植物失败率。历史系列研究可能因移植处理方法而产生偏差,这些方法会降低供体肌腱的生物力学特性,如辐照。超临界二氧化碳(SCCO)是一种经过验证的在生理温度下对生物材料进行终端灭菌且无需辐照的方法,但迄今为止,尚未有关于将SCCO处理的肌腱同种异体移植物用于初次ACLR的体内应用报道。

假设

采用SCCO同种异体移植物进行ACLR在术后2年将产生可接受的失败率、主观膝关节评分和临床评估结果。

研究设计

病例系列;证据等级,4级。

方法

患者接受了使用经过终端灭菌的SCCO处理的人股薄肌、腓骨长肌、半腱肌、胫骨前肌和胫骨后肌腱同种异体移植物的初次ACLR。收集患者人口统计学数据以及肌腱供体的年龄和性别。术后1年,收集国际膝关节文献委员会(IKDC)主观评分和ACL损伤后恢复运动(ACL-RSI)评分以及临床评估结果。术后2年,重复进行IKDC和ACL-RSI评分,并记录恢复运动情况和进一步的膝关节损伤。

结果

共有144例患者构成研究组,中位年龄为26(四分位间距14)岁。患者以男性为主(58%)。失访率为8%(n = 12)。同种异体肌腱供体的平均年龄为37(范围17 - 58)岁,大多数为男性(83%)。同种异体移植物的平均直径为8.9±1.0 mm。在2年时,ACL移植物失败发生在5%(n = 7)的患者中。所有移植物失败均发生在年龄≤25岁的患者中(P = 0.007)。供体年龄(≤40岁或>40岁)和供体性别均与移植物失败无关(P>0.05)。IKDC主观评分中位数为95,ACL-RSI评分为75。术后前2年内没有因感染而进行的翻修手术。

结论

在一系列连续的初次ACLR患者中,SCCO处理的同种异体肌腱在术后24个月显示出令人满意的临床和患者报告的结果,与已发表的绳肌自体移植物和新鲜冷冻未辐照同种异体移植物系列报道相比,ACL移植物失败率和主观膝关节评分相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/423d/11318055/8498eeeeff37/10.1177_23259671241254115-fig6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/423d/11318055/ebdb4378a54d/10.1177_23259671241254115-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/423d/11318055/11119c849574/10.1177_23259671241254115-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/423d/11318055/5ad78b967c6a/10.1177_23259671241254115-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/423d/11318055/c01d15dd4c28/10.1177_23259671241254115-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/423d/11318055/d392bf5ab83c/10.1177_23259671241254115-fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/423d/11318055/8498eeeeff37/10.1177_23259671241254115-fig6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/423d/11318055/ebdb4378a54d/10.1177_23259671241254115-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/423d/11318055/11119c849574/10.1177_23259671241254115-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/423d/11318055/5ad78b967c6a/10.1177_23259671241254115-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/423d/11318055/c01d15dd4c28/10.1177_23259671241254115-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/423d/11318055/d392bf5ab83c/10.1177_23259671241254115-fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/423d/11318055/8498eeeeff37/10.1177_23259671241254115-fig6.jpg

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