Mutsuzaki Hirotaka, Kinugasa Tomonori, Sakane Masataka
Department of Orthopaedic Surgery, Ibaraki Prefectural University of Health Sciences, 4669-2 Ami Ami-machi, Inashiki-gun, Ibaraki, 300-0394, Japan.
Department of Orthopaedic Surgery, Ichihara Hospital, 3681 Oozone, Tsukuba, Ibaraki, 300-3295, Japan.
J Orthop. 2019 May 1;16(5):422-425. doi: 10.1016/j.jor.2019.04.004. eCollection 2019 Sep-Oct.
To improve tendon-to-bone healing in anterior cruciate ligament (ACL) reconstruction, a novel technique via the calcium phosphate (CaP) hybridization method for tendon graft using an alternate soaking process was developed. The use of the CaP hybridization method for quadriceps tendon-bone (QTB) graft in ACL reconstruction has not been reported in previous studies. Thus, this clinical trial aimed to clarify the safety and feasibility of using CaP hybridization method for quadriceps tendon-bone (QTB) graft in ACL reconstruction.
Eight patients (average age, 41.6 ± 10.6 years; 2 men and 6 women) with unilateral ACL injury were included in this study. They underwent ACL reconstruction using QTB graft that hybridized CaP. The follow-up period was from 2 months to 4 years (average, 2.4 ± 1.5 years). Cases of adverse events, including tumor formation, infection, fracture, contracture, severe pain, and re-rupture, were recorded. Moreover, clinical results (KT-1000 arthrometry, pivot-shift test, International Knee Documentation Committee grade, Lysholm scale, and sports activity level), and images of graft and bone tunnel (magnetic resonance imaging, arthroscopic appearance, and computed tomography) were also evaluated.
No adverse events were observed in the follow-up periods. Postoperative clinical results showed improvement compared with the preoperative findings. The sports activity level after the surgery became equivalent to that before injury. There was no progression of bone tunnel enlargement.
Using the CaP hybridization method for QTB graft in ACL reconstruction was safe and feasible in the clinical trial. Moreover, this method may improve clinical outcomes. In the future, it is necessary to verify the effect of the CaP hybridization method for QTB graft in ACL reconstruction.
为改善前交叉韧带(ACL)重建中肌腱与骨的愈合,开发了一种通过磷酸钙(CaP)杂交方法对肌腱移植物进行交替浸泡处理的新技术。以往研究中尚未报道在ACL重建中使用CaP杂交方法处理股四头肌肌腱-骨(QTB)移植物。因此,本临床试验旨在阐明在ACL重建中使用CaP杂交方法处理QTB移植物的安全性和可行性。
本研究纳入8例单侧ACL损伤患者(平均年龄41.6±10.6岁;男性2例,女性6例)。他们接受了使用CaP杂交的QTB移植物进行的ACL重建。随访期为2个月至4年(平均2.4±1.5年)。记录不良事件,包括肿瘤形成、感染、骨折、挛缩、剧痛和再断裂。此外,还评估了临床结果(KT-1000关节测径仪、轴移试验、国际膝关节文献委员会分级、Lysholm评分和运动活动水平)以及移植物和骨隧道的影像(磁共振成像、关节镜表现和计算机断层扫描)。
随访期间未观察到不良事件。术后临床结果与术前相比有所改善。术后运动活动水平恢复到受伤前水平。骨隧道未出现扩大进展。
在本临床试验中,使用CaP杂交方法处理ACL重建中的QTB移植物是安全可行的。此外,该方法可能改善临床结果。未来,有必要验证CaP杂交方法处理ACL重建中QTB移植物的效果。