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前瞻性随机比较 ACL 重建中照射和未照射的腘绳肌腱同种异体移植物。

A prospective randomized comparison of irradiated and non-irradiated hamstring tendon allograft for ACL reconstruction.

机构信息

Department of Joint Surgery, The Affiliated Hospital of Medical College, Qingdao University, No. 16 Jiangsu Road, 266003, Qingdao, Shandong, China.

出版信息

Knee Surg Sports Traumatol Arthrosc. 2012 Jan;20(1):187-94. doi: 10.1007/s00167-010-1393-9. Epub 2011 Feb 3.

DOI:10.1007/s00167-010-1393-9
PMID:21290113
Abstract

PURPOSE

To analyze the outcome of arthroscopic anterior cruciate ligament reconstruction with irradiated versus non-irradiated hamstring tendon allograft.

METHODS

All hamstring tendon allografts were obtained from a single certified tissue bank, and the irradiated allografts were sterilized with 2.5 Mrad of irradiation prior to distribution. A total of 78 patients who met the inclusion and exclusion criteria of the study were prospectively randomized consecutively into two groups (Non-ir-Allo vs. Ir-Allo). All the operations were done by the same senior surgeon. Before surgery and at follow-up, patients were evaluated by the same observer according to clinical evaluations including the Lachman test, ADT, pivot shift test, varus/valgus stress test, the instrumented KT-2000 arthrometer testing, vertical jump test, one-leg hop test, ROM of knee, Cincinnati knee score, IKDC Subjective Knee Form, Tegner activity score, modified Lysholm knee scoring scale, and the standard knee ligament evaluation form of the IKDC.

RESULTS

Of these patients, 69 (Non-ir-Allo 38, Ir-Allo 31) were available for full evaluation. When compared the Ir-Allo group with Non-ir-Allo group at the final follow-up by Lachman test, ADT, pivot shift test, and KT-2000 arthrometer testing, statistically significant differences were found (P < 0.05). Most importantly, 84% of patients in the Non-ir-Auto group and just only 32% in the Ir-Allo group had a side-to-side difference of less than 3 mm according to KT-2000. The anterior and rotational stability decreased significantly in the Ir-Allo group. According to the overall IKDC, functional, subjective evaluations, and activity level testing, no statistically significant differences were found between the two groups (n.s.). As to the osteoarthritis (OA) rate, for the Non-ir-Allo group, there was no significant difference (n.s.) in development of OA between the operated knee and contralateral knee at the final follow-up. While for the Ir-Allo group, significant difference (P < 0.05) was found in development of OA between the operated knee and contralateral knee. There was statistical difference (P < 0.05) between the Non-ir-Allo and Ir-Allo groups when comparing the development of OA of the operated knees at the final follow-up.

CONCLUSION

There was a significant difference in knee stability between the two groups (in favor of Non-ir-Allo), but no differences in functional scores should be pointed out clearly.

LEVEL OF EVIDENCE

I.

摘要

目的

分析关节镜下前交叉韧带重建中使用辐照与未辐照腘绳肌腱移植物的结果。

方法

所有腘绳肌腱移植物均来自于一家经认证的组织库,辐照移植物在分配前使用 2.5 Mrad 的辐照进行消毒。共有 78 名符合研究纳入和排除标准的患者被连续前瞻性随机分为两组(非辐照组与辐照组)。所有手术均由同一位资深外科医生进行。术前和随访时,同一观察者根据临床评估对患者进行评估,包括 Lachman 试验、ADT、髌股关节移位试验、内翻/外翻应力试验、仪器化 KT-2000 关节测量仪测试、垂直跳跃测试、单腿跳跃测试、膝关节活动度、辛辛那提膝关节评分、IKDC 主观膝关节评分、Tegner 活动评分、改良 Lysholm 膝关节评分和 IKDC 标准膝关节韧带评估表。

结果

这些患者中,69 例(非辐照组 38 例,辐照组 31 例)可进行完整评估。在最终随访时,与非辐照组相比,辐照组的 Lachman 试验、ADT、髌股关节移位试验和 KT-2000 关节测量仪测试结果存在统计学差异(P<0.05)。最重要的是,84%的非辐照组患者和仅 32%的辐照组患者的 KT-2000 侧-侧差值小于 3mm。辐照组的前向和旋转稳定性明显下降。根据整体 IKDC、功能、主观评估和活动水平测试,两组之间无统计学差异(n.s.)。至于骨关节炎(OA)发生率,对于非辐照组,最终随访时手术侧膝关节与对侧膝关节之间 OA 的发展无显著差异(n.s.)。而对于辐照组,手术侧膝关节与对侧膝关节之间 OA 的发展有显著差异(P<0.05)。与最终随访时手术侧膝关节的 OA 发展相比,非辐照组与辐照组之间有统计学差异(P<0.05)。

结论

两组间膝关节稳定性存在显著差异(非辐照组更优),但功能评分无明显差异。

证据水平

I 级。

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