自体骨移植物与硅酸钙取代的磷酸钙在 2 期翻修前交叉韧带重建中治疗隧道缺损的比较：一项前瞻性、随机对照研究，随访时间至少 2 年。
Autologous Bone Graft Versus Silicate-Substituted Calcium Phosphate in the Treatment of Tunnel Defects in 2-Stage Revision Anterior Cruciate Ligament Reconstruction: A Prospective, Randomized Controlled Study With a Minimum Follow-up of 2 Years.
机构信息
Department for Trauma and Orthopaedic Surgery, BG Trauma Center Ludwigshafen, University of Heidelberg, Ludwigshafen on the Rhine, Germany.
Department for Shoulder and Elbow Surgery, Arcus Clinic Pforzheim, Pforzheim, Germany.
出版信息
Arthroscopy. 2020 Jan;36(1):178-185. doi: 10.1016/j.arthro.2019.07.035.
PURPOSE
To compare and evaluate knee laxity and functional outcomes between autologous bone graft and silicate-substituted calcium phosphate (Si-CaP) in the treatment of tunnel defects in 2-stage revision anterior cruciate ligament reconstruction (ACLR).
METHODS
This prospective, randomized controlled trial was conducted between 2012 and 2015 with a total of 40 patients who underwent 2-stage revision ACLR. The tunnels were filled with autologous iliac crest cancellous bone graft in 20 patients (control group) and with Si-CaP in the other 20 patients (intervention group). After a minimum follow-up period of 2 years, functional outcomes were assessed by KT-1000 arthrometry (side-to-side [STS] difference), the Tegner score, the Lysholm score, and the International Knee Documentation Committee score.
RESULTS
A total of 37 patients (follow-up rate, 92.5%) with an average age of 31 years were followed up for 3.4 years (range, 2.2-5.5 years). The KT-1000 measurement did not show any STS difference between the bone graft group (0.9 ± 1.5 mm) and the Si-CaP group (0.7 ± 2.0 mm) (P = .731). One patient in the intervention group (5%) had an STS difference greater than 5 mm. Both groups showed significant improvements in the Tegner score, Lysholm score, and International Knee Documentation Committee score from preoperative assessment to final follow-up (P ≤ .002), without any difference between the 2 groups (P ≥ .396). Complications requiring revision occurred in 4 control patients (22%) and in 2 patients in the intervention group (11%) (P = .660). No complications in relation to Si-CaP were observed.
CONCLUSIONS
Equivalent knee laxity and clinical function outcomes were noted 3 years after surgery in both groups of patients. Si-CaP bone substitute is therefore a safe alternative to autologous bone graft for 2-stage ACLR.
LEVEL OF EVIDENCE
Level I, prospective, randomized controlled clinical trial.
目的
比较并评估自体骨移植物与硅酸钙磷（Si-CaP）在治疗 2 期前交叉韧带重建（ACLR）隧道缺损中的膝关节松弛度和功能结果。
方法
这是一项前瞻性、随机对照试验，于 2012 年至 2015 年进行，共有 40 例患者接受了 2 期 ACLR。20 例患者（对照组）的隧道用自体髂嵴松质骨移植物填充，20 例患者（干预组）用 Si-CaP 填充。在至少 2 年的随访后，通过 KT-1000 关节测量仪（膝关节间隙差值，STS）、Tegner 评分、Lysholm 评分和国际膝关节文献委员会评分评估功能结果。
结果
共有 37 例患者（随访率 92.5%），平均年龄 31 岁，随访时间为 3.4 年（范围为 2.2-5.5 年）。KT-1000 测量结果显示，骨移植物组（0.9 ± 1.5mm）和 Si-CaP 组（0.7 ± 2.0mm）之间无明显 STS 差异（P=.731）。干预组中有 1 例患者（5%）的 STS 差值大于 5mm。两组患者的 Tegner 评分、Lysholm 评分和国际膝关节文献委员会评分均从术前评估到最终随访时均显著改善（P≤.002），但两组之间无差异（P≥.396）。对照组中有 4 例患者（22%）和干预组中有 2 例患者（11%）需要翻修的并发症（P=.660）。未观察到与 Si-CaP 相关的并发症。
结论
两组患者术后 3 年膝关节松弛度和临床功能结果相当。因此，Si-CaP 骨替代物是 2 期 ACLR 自体骨移植物的安全替代物。
证据等级
I 级，前瞻性、随机对照临床试验。
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