Department of Orthopedics and Trauma Surgery, Medical Center, Faculty of Medicine, Albert-Ludwigs-University of Freiburg, Freiburg, Germany; Department of Knee, Hip and Shoulder Surgery, Schoen Clinic Munich Harlaching, Munich, Germany.
Department of Knee, Hip and Shoulder Surgery, Schoen Clinic Munich Harlaching, Munich, Germany.
Arthroscopy. 2018 Sep;34(9):2647-2653. doi: 10.1016/j.arthro.2018.03.034. Epub 2018 Jun 21.
To compare anatomic single-bundle (SB) with double-bundle (DB) anterior cruciate ligament reconstruction (ACL-R) and to evaluate the respective clinical outcome results.
In a prospective randomized study, 64 patients were included and separated into 2 groups. Anatomic SB and DB ACL-Rs were performed with hamstring tendons. Five years after surgery, the follow-up (FU) examination comprised International Knee Documentation Committee (IKDC) 2000, Laxitester (ORTEMA Sport Protection, Markgroeningen, Germany) measurement, and radiograph evaluation. Power calculation was performed to achieve a 95% confidence interval and 80% power on the base of 7-point IKDC subjective difference between the groups.
A total of 53 patients (83% FU) were examined at 63.2 ± 4.7 months after surgery: 28 patients in the DB group and 25 patients in the SB group. IKDC subjective (SB: 92.8 ± 6.2, DB: 91.6 ± 7.1; P = .55) and objective scores (grade A SB/DB 20%/25%, B SB/DB 72%/57%, C SB/DB 8%/18%, D SB/DB 4%/0%; P = .45) showed no differences comparing both groups. The Laxitester measurements showed no significant difference in regard to anterior-posterior translation in neutral, internal, and external rotation or to rotation angles (P = .79). No difference was seen between the groups regarding osteoarthritic changes and tunnel widening.
At the 5-year FU, no advantage for either the DB or SB technique in ACL-R can be seen with regard to patient-related and objective outcome measures.
Level I, prospective randomized controlled clinical trial.
比较解剖学单束(SB)与双束(DB)前交叉韧带重建(ACL-R),并评估各自的临床结果。
前瞻性随机研究纳入 64 例患者并分为 2 组。使用腘绳肌腱进行解剖学 SB 和 DB ACL-R。术后 5 年,随访(FU)检查包括国际膝关节文献委员会(IKDC)2000 评分、Laxitester(ORTEMA Sport Protection,Markgroeningen,德国)测量和影像学评估。根据组间 7 分 IKDC 主观差异,进行了功效计算,以达到 95%置信区间和 80%功效。
共有 53 例患者(83%FU)在术后 63.2±4.7 个月接受检查:DB 组 28 例,SB 组 25 例。IKDC 主观评分(SB:92.8±6.2,DB:91.6±7.1;P=.55)和客观评分(A级 SB/DB 20%/25%,B 级 SB/DB 72%/57%,C 级 SB/DB 8%/18%,D 级 SB/DB 4%/0%;P=.45)比较两组无差异。Laxitester 测量在中立、内旋和外旋以及旋转角度的前后平移方面无显著差异(P=.79)。两组间在骨关节炎变化和隧道增宽方面无差异。
在 5 年 FU 时,无论是 DB 还是 SB 技术,在 ACL-R 方面,在患者相关和客观的结果测量方面均无优势。
1 级,前瞻性随机对照临床试验。