Lind Martin, Nielsen Torsten Grønbech, Nielsen Flemming K, Sørensen Ole G, Mygind-Klavsen Bjarne, Faunø Peter
Department of Orthopaedics Aarhus University Hospital Aarhus Denmark.
J Exp Orthop. 2024 Oct 21;11(4):e70016. doi: 10.1002/jeo2.70016. eCollection 2024 Oct.
Absorbable interference screws for anterior cruciate ligament reconstruction (ACLR) can lead to tunnel widening and cyst formation. The Biosure Regenesorb interference screw (Smith & Nephew). has been developed with an optimised calcium phosphate/polymer composition to promote bone formation during resorption. The present study aims to investigate screw resorption, new bone formation, and tunnel geometry following ACLR with Biosure Regenesorb screw tibial fixation.
The study is a prospective single-centre case series of 12 patients with ACL lesions and treated with ACLR using hamstring tendon autograft with Biosure Regenesorb interference screw tibial fixation with a two-year follow-up period. The Biosure Regenesorb consists of 65% polylactide-glycolic acid poly. 20% calcium sulphate and 15% tricalcium phosphate. Primary endpoint: Tunnel volume. implant volume and new bone formation in the tibial tunnel is evaluated by quantitative computed tomography (CT) scanning. Secondary endpoints: Arthrometric knee laxity, International Knee Documentation Committee (IKDC) and Knee Osteoarthritis and Injury Outcome Scores (KOOS) and Tegner activity scale.
Screw volume decreased to 44% within the two-year follow-up period while tunnel volume remained unchanged. Only a minor amount (<1% of tunnel volume) of new bone formation in the screw remnants was observed. Sagittal knee laxity at one year was 0.9 mm. The IKDC score increased by 15 points and the KOOS sport and KOOS quality of life scores increased by 25 and 26 points. respectively.
ACLR using Biosure Regenesorb interference screw does not result in tunnel widening. showing a screw resorption of 44% after two years and minor new bone formation. Knee stability and subjective outcome improvements are as expected after other ACLR methods.
IV.
用于前交叉韧带重建（ACLR）的可吸收干扰螺钉可导致隧道扩大和囊肿形成。Biosure Regenesorb干扰螺钉（施乐辉公司）采用优化的磷酸钙/聚合物成分开发，以在吸收过程中促进骨形成。本研究旨在探讨采用Biosure Regenesorb螺钉胫骨固定进行ACLR后的螺钉吸收、新骨形成和隧道几何形状。
本研究是一项前瞻性单中心病例系列研究，纳入12例ACL损伤患者，采用自体腘绳肌腱移植和Biosure Regenesorb干扰螺钉胫骨固定进行ACLR治疗，随访两年。Biosure Regenesorb由65%聚丙交酯-乙交酯共聚物、20%硫酸钙和15%磷酸三钙组成。主要终点：通过定量计算机断层扫描（CT）评估胫骨隧道的隧道体积、植入物体积和新骨形成。次要终点：膝关节测量松弛度、国际膝关节文献委员会（IKDC）评分、膝关节骨关节炎和损伤结果评分（KOOS）以及Tegner活动量表。
在两年随访期内，螺钉体积减少至44%，而隧道体积保持不变。仅在螺钉残余物中观察到少量新骨形成（<隧道体积的1%）。一年时矢状位膝关节松弛度为0.9mm。IKDC评分提高了15分，KOOS运动和KOOS生活质量评分分别提高了25分和26分。
使用Biosure Regenesorb干扰螺钉进行ACLR不会导致隧道扩大，两年后螺钉吸收44%，新骨形成较少。膝关节稳定性和主观结果改善与其他ACLR方法预期的结果相同。
IV级。
