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自体腘绳肌腱移植前交叉韧带重建中生物可吸收螺钉与钛螺钉的比较:一项为期5年随访的前瞻性、盲法、随机对照试验

Bioabsorbable Versus Titanium Screws in Anterior Cruciate Ligament Reconstruction Using Hamstring Autograft: A Prospective, Blinded, Randomized Controlled Trial With 5-Year Follow-up.

作者信息

Arama Yuval, Salmon Lucy J, Sri-Ram Kesavan, Linklater James, Roe Justin P, Pinczewski Leo A

机构信息

North Sydney Orthopaedic and Sports Medicine Centre, Sydney, Australia.

Castlereagh Imaging, Sydney, Australia.

出版信息

Am J Sports Med. 2015 Aug;43(8):1893-901. doi: 10.1177/0363546515588926. Epub 2015 Jun 24.

Abstract

BACKGROUND

Longer-term results of bioabsorbable screws for anterior cruciate ligament reconstruction (ACLR) have been reported, but results are specific to the exact screw material and design. Titanium and poly-L-lactic acid with hydroxyapatite (PLLA-HA) screw outcomes have been compared only to 2 years.

PURPOSE/HYPOTHESIS: The purpose of this study was to compare the clinical and radiologic outcomes of the PLLA-HA screw versus titanium screw for hamstring tendon ACLR over a 5-year follow-up period. The hypothesis was that there are no differences in clinical scores or tunnel widening between the PLLA-HA and the titanium screws and that the PLLA-HA screw as seen on magnetic resonance imaging (MRI) should show high-grade resorption and ossification response over 5 years.

STUDY DESIGN

Randomized controlled trial; Level of evidence, 1.

METHODS

A total of 40 patients undergoing ACLR were randomized to receive either a PLLA-HA screw (PLLA-HA group) or a titanium screw (titanium group) for ACL fixation. Blinded evaluation was performed at 2 and 5 years with the International Knee Documentation Committee and Lysholm knee score, KT-1000 arthrometer, single-legged hop test, and MRI to evaluate tunnel and screw volumes, periscrew ossification, graft integration, and cyst formation.

RESULTS

There was no difference in any clinical outcome measure at 2- or 5-year follow-up between the 2 groups. At 2 years, the femoral tunnel in the PLLA-HA group was smaller than that in the titanium group (P = .02); at 5 years, there was no difference. At 2 years, the femoral PLLA-HA screw was a mean 76% of its original volume, and by 5 years, it was 36%. At 2 years, the tibial PLLA-HA screw mean volume was 68% of its original volume, and by 5 years, it was 46%. At 5 years in the PLLA-HA group, 88% of femoral tunnels and 56% of tibial tunnels demonstrated a significant ossification response. There was no increase in cyst formation in the PLLA-HA group and no screw breakages.

CONCLUSION

There were equivalent clinical results between the PLLA-HA and titanium groups at 2- and 5-year follow-ups. The PLLA-HA screw was not associated with increased tunnel widening or cyst formation when compared with the titanium screw. The PLLA-HA screw demonstrated progressive screw resorption and gradual but incomplete ossification over 5 years.

摘要

背景

已有关于生物可吸收螺钉用于前交叉韧带重建(ACLR)的长期结果的报道,但结果特定于确切的螺钉材料和设计。钛螺钉和含羟基磷灰石的聚-L-乳酸(PLLA-HA)螺钉的结果仅比较到2年。

目的/假设:本研究的目的是比较PLLA-HA螺钉与钛螺钉用于腘绳肌腱ACLR在5年随访期内的临床和影像学结果。假设是PLLA-HA螺钉和钛螺钉在临床评分或隧道增宽方面没有差异,并且在磁共振成像(MRI)上观察到的PLLA-HA螺钉在5年内应显示出高级别的吸收和骨化反应。

研究设计

随机对照试验;证据等级,1级。

方法

总共40例行ACLR的患者被随机分配接受PLLA-HA螺钉(PLLA-HA组)或钛螺钉(钛组)用于ACL固定。在2年和5年时采用国际膝关节文献委员会和Lysholm膝关节评分、KT-1000关节测量仪、单腿跳测试以及MRI进行盲法评估,以评估隧道和螺钉体积、螺钉周围骨化、移植物整合和囊肿形成情况。

结果

两组在2年或5年随访时的任何临床结局指标上均无差异。在2年时,PLLA-HA组的股骨隧道小于钛组(P = 0.02);在5年时,无差异。在2年时,股骨PLLA-HA螺钉平均体积为其原始体积的76%,到5年时为36%。在2年时,胫骨PLLA-HA螺钉平均体积为其原始体积的68%,到5年时为46%。在PLLA-HA组5年时,88%的股骨隧道和56%的胫骨隧道显示出明显的骨化反应。PLLA-HA组囊肿形成无增加,也无螺钉断裂。

结论

PLLA-HA组和钛组在2年和5年随访时临床结果相当。与钛螺钉相比,PLLA-HA螺钉与隧道增宽或囊肿形成增加无关。PLLA-HA螺钉在5年内显示出逐渐的螺钉吸收和逐渐但不完全的骨化。

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