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比较复合生物可吸收螺钉和同种异体干涉螺钉在前交叉韧带重建中髌腱移植固定的前瞻性评估

Prospective evaluation of patellar tendon graft fixation in anterior cruciate ligament reconstruction comparing composite bioabsorbable and allograft interference screws.

作者信息

Tecklenburg Katja, Burkart Peter, Hoser Christian, Rieger Michael, Fink Christian

机构信息

Department of Trauma Surgery and Sports Medicine, Medical University Innsbruck, Innsbruck, Austria.

出版信息

Arthroscopy. 2006 Sep;22(9):993-9. doi: 10.1016/j.arthro.2006.05.010.

Abstract

PURPOSE

Bioabsorbable interference screws have proved to be biologically safe and to provide adequate graft fixation. Metallic interference screws have therefore been continuously replaced over the years. However, degradation times are highly variable, and bony replacement of the screw does not always occur in human beings. Composite interference screws have recently been introduced to enhance bony integration. We evaluated 2 different composite interference screws and compared them with an allograft interference screw over a 2-year period after anterior cruciate ligament (ACL) reconstruction with an autologous bone-patellar tendon-bone graft.

METHODS

Three groups of patients were prospectively evaluated. Poly-L-lactid acid/hydroxyapatite composite screws (BioRCI-HA; Smith & Nephew, Andover, MA) (group A), poly-L-lactid acid/beta-tricalcium phosphate composite screws (Bilok; Atlantech, Radevormwald, Germany) (group B), or allograft interference screws (CorlS; Regeneration Technologies, Alachua, FL) (group C) were used for tibial fixation of a patellar tendon autograft in ACL reconstruction. Each group consisted of 20 patients (mean age, 32.2 +/- 10.9 years in group A, 32.3 +/- 10.6 years in group B, and 31.1 +/- 6.6 years in group C) with no significant (P < .05) differences in age, sex, and time of follow-up. Subjective and clinical International Knee Documentation Committee parameters were evaluated preoperatively and at 3, 12, and 24 months postoperatively; computed tomography scans were obtained postoperatively and at 3, 12, and 24 months; and magnetic resonance imaging (MRI) scans were obtained at 3 and 24 months postoperatively.

RESULTS

Screw breakage during insertion occurred in 2 cases (1 in group A and 1 in group B). There was no significant (P < .05) difference in subjective and clinical results at any time of follow-up. No inflammatory response could be detected on MRI in any of the patients in all groups. Computed tomography scans documented complete bone block incorporation at 3 months in all groups. Both composite interference screws showed signs of degradation but were still clearly visible 24 months after ACL reconstruction. At 12 months, a sclerotic rim around the screw cavity could be outlined in group B only. No bony replacement had taken place up to 24 months postoperatively in group A or B. In group C the allograft bone screw was completely integrated and barely visible after 24 months.

CONCLUSIONS

All 3 screw types provided adequate graft fixation and were associated with excellent clinical results and no inflammatory response on MRI. Ultimately, a resorbable screw has to be replaced by bone to facilitate revision surgery. Formation of a sclerotic rim around the outline of the screw makes later bony replacement (group B) unlikely. After 24 months, complete bony integration had only taken place when allograft screws were used.

CLINICAL RELEVANCE

At 24 months, no advantage of composite screw materials over conventional bioabsorbable screws could be detected. If composite materials will be of any advantage with respect to bony replacement has to be observed with longer-term follow-up. The allograft bone screw was completely incorporated and replaced by cancellous bone after 24 months. Unfortunately, the screw's more complicated handling, higher cost, and limited availability impair the possibilities for its standard clinical use.

摘要

目的

生物可吸收挤压螺钉已被证明具有生物安全性,并能提供足够的移植物固定效果。因此,多年来金属挤压螺钉已逐渐被取代。然而,其降解时间差异很大,而且在人体中螺钉并不总能被骨组织替代。最近引入了复合挤压螺钉以增强骨整合。我们在采用自体骨 - 髌腱 - 骨移植物重建前交叉韧带(ACL)后,对两种不同的复合挤压螺钉进行了为期2年的评估,并将它们与同种异体移植物挤压螺钉进行比较。

方法

前瞻性评估三组患者。在ACL重建中,使用聚 - L - 乳酸/羟基磷灰石复合螺钉(BioRCI - HA;史赛克公司,安多弗,马萨诸塞州)(A组)、聚 - L - 乳酸/β - 磷酸三钙复合螺钉(Bilok;亚特兰泰克公司,拉德沃姆瓦尔德,德国)(B组)或同种异体移植物挤压螺钉(CorlS;再生技术公司,阿拉楚阿,佛罗里达州)(C组)对髌腱自体移植物进行胫骨固定。每组由20例患者组成(A组平均年龄32.2±10.9岁,B组平均年龄32.3±10.6岁,C组平均年龄31.1±6.6岁),在年龄、性别和随访时间方面无显著(P <.05)差异。术前以及术后3、12和24个月评估主观和临床国际膝关节文献委员会参数;术后以及术后3、12和24个月进行计算机断层扫描;术后3和24个月进行磁共振成像(MRI)扫描。

结果

插入过程中螺钉断裂发生2例(A组1例,B组1例)。在任何随访时间,主观和临床结果均无显著(P <.05)差异。所有组的任何患者在MRI上均未检测到炎症反应。计算机断层扫描显示所有组在3个月时骨块完全融合。两种复合挤压螺钉均显示出降解迹象,但在ACL重建后24个月仍清晰可见。在12个月时,仅B组螺钉腔周围可勾勒出硬化边缘。术后24个月时,A组或B组均未发生骨替代。在C组,同种异体骨螺钉在24个月后完全整合且几乎不可见。

结论

所有三种螺钉类型均能提供足够的移植物固定,临床效果良好,且在MRI上无炎症反应。最终,可吸收螺钉必须被骨组织替代以利于翻修手术。螺钉轮廓周围形成硬化边缘使得后期骨替代(B组)不太可能发生。24个月后,仅在使用同种异体移植物螺钉时发生了完全骨整合。

临床意义

在24个月时,未检测到复合螺钉材料相对于传统生物可吸收螺钉有任何优势。复合材料在骨替代方面是否具有优势必须通过长期随访观察。同种异体骨螺钉在24个月后完全融合并被松质骨替代。不幸的是,该螺钉操作更复杂、成本更高且供应有限,限制了其在标准临床应用中的可能性。

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