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用于前交叉韧带重建中移植物固定的可生物吸收Milagro干涉螺钉的磁共振成像分析

Magnetic resonance imaging analysis of the bioabsorbable Milagro interference screw for graft fixation in anterior cruciate ligament reconstruction.

作者信息

Frosch K-H, Sawallich T, Schütze G, Losch A, Walde T, Balcarek P, Konietschke F, Stürmer K M

机构信息

Department of Trauma Surgery, Plastic and Reconstructive Surgery, Georg-August-University Goettingen, Robert-Koch-Str. 40, 37075, Goettingen, Germany,

出版信息

Strategies Trauma Limb Reconstr. 2009 Oct;4(2):73-9. doi: 10.1007/s11751-009-0063-2. Epub 2009 Aug 21.

Abstract

Ligament graft fixation with bioabsorbable interference screws is a standard procedure in cruciate ligament replacement. Previous screw designs may resorb incompletely, and can cause osteolysis and sterile cysts despite being implanted for several years. The aim of this study was to examine the in vivo degradation and biocompatibility of the new Milagro interference screw (Mitek, Norderstedt, Germany). The Milagro interference screw is made of 30% ss-TCP (TriCalcium phosphate) and 70% PLGA (Poly-lactic-co-glycolic acid). In the period between June 2005 and February 2006, 38 patients underwent graft fixation with Milagro screws in our hospital. Arthroscopic ACL reconstruction was performed using hamstring tendon grafts in all the patients. MR imaging was performed on 12 randomly selected patients out of the total of 38 at 3, 6 and 12 months after surgery. During the examination, the volume loss of the screw, tunnel enlargement, presence of osteolysis, fluid lines, edema and postoperative screw replacement by bone tissue were evaluated. There was no edema or signs of inflammation around the bone tunnels. At 3, 6 and 12 months, the tibial screws showed an average volume loss of 0, 8.1% (+/-7.9%) and 82.6% (+/-17.2%, P < 0.05), respectively. The femoral screws showed volume losses of 2.5% (+/-2.1%), 31.3% (+/-21.6%) and 92.02% (+/-6.3%, P < 0.05), respectively. The femoral tunnel enlargement was 47.4% (+/-43.8%) of the original bone tunnel volume after 12 months, and the mean tunnel volume of the tibial tunnel was -9.5% (+/-58.1%) compared to the original tunnel. Bone ingrowth was observed in all the patients. In conclusion, the resorption behaviour of the Milagro screw is closely linked to the graft healing process. The screws were rapidly resorbed after 6 months and, at 12 months, only the screw remnants were detectable. Moreover, the Milagro screw is biocompatible and osteoconductive, promoting bone ingrowth during resorption. Tunnel enlargement is not prevented in the first months but is reduced by bone ingrowth after 12 months.

摘要

使用生物可吸收干涉螺钉进行韧带移植固定是十字韧带置换的标准手术。以往的螺钉设计可能吸收不完全,即使植入数年也可能导致骨质溶解和无菌性囊肿。本研究的目的是检测新型Milagro干涉螺钉(德国诺德施泰特米泰克公司)在体内的降解情况和生物相容性。Milagro干涉螺钉由30%的ss-TCP(磷酸三钙)和70%的PLGA(聚乳酸-乙醇酸共聚物)制成。在2005年6月至2006年2月期间,我院38例患者使用Milagro螺钉进行了移植固定。所有患者均采用腘绳肌腱移植进行关节镜下前交叉韧带重建。从38例患者中随机选取12例,在术后3、6和12个月进行磁共振成像检查。检查期间,评估螺钉的体积损失、隧道扩大情况、骨质溶解的存在、液性线、水肿以及术后螺钉被骨组织替代的情况。骨隧道周围未出现水肿或炎症迹象。在3、6和12个月时,胫骨螺钉的平均体积损失分别为0、8.1%(±7.9%)和82.6%(±17.2%,P<0.05)。股骨螺钉的体积损失分别为2.5%(±2.1%)、31.3%(±21.6%)和92.02%(±6.3%,P<0.05)。12个月后,股骨隧道扩大为原始骨隧道体积的47.4%(±43.8%),胫骨隧道的平均隧道体积与原始隧道相比为-9.5%(±58.1%)。所有患者均观察到骨长入。总之,Milagro螺钉的吸收行为与移植愈合过程密切相关。螺钉在6个月后迅速吸收,在12个月时,仅可检测到螺钉残余物。此外,Milagro螺钉具有生物相容性和骨传导性,在吸收过程中促进骨长入。最初几个月无法防止隧道扩大,但12个月后骨长入可使其减小。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bd00/2746274/e5ceda46f25a/11751_2009_63_Fig1_HTML.jpg

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