Similar results with quadrupled semitendinosus and semitendinosus-gracilis graft in anterior cruciate ligament reconstruction: A randomised controlled trial with 2-year follow-up

IF 2.7 Q2 ORTHOPEDICS

Journal of Experimental Orthopaedics Pub Date : 2025-09-24 DOI:10.1002/jeo2.70399

Juan P. Martinez-Cano, Alejandro Gallego, Janio Cuadros, Laura Ibarra, Fernando M. Mejía, María V. Velasquez-Hammerle, Alfredo Martinez-Rondanelli

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Abstract

Purpose

to compare quadrupled semitendinosus (STx4) with semitendinosus-gracilis graft in anterior cruciate ligament (ACL) reconstruction surgery.

Methods

Parallel randomised controlled trial with two groups of treatment (n = 42) in primary ACL reconstruction surgery. Follow-up during 2 years after surgery with visits at 3, 6, 12 and 24 months. Primary outcome: quadriceps and hamstrings strength in newtons (N). Secondary outcomes: ACL re-rupture, additional surgeries, return to sport and patient-reported outcomes (PROMs): knee injury and osteoarthritis outcome score (KOOS), International Knee Documentation Committee (IKDC) and Tegner-Lysholm.

Results

There was 1/21 ACL re-rupture for STx4 and 2/21 for the control group (p = 0.9). One additional surgery for each group: ACL revision (control group) and meniscectomy (STx4). There were no other complications and no differences in PROMs between grafts, except for Tegner-Lysholm at 3 months, that favoured the STx4 group (76.0, confidence interval [CI]: 56.0–86.0 vs. 85.0, CI: 77.0–93.0), p = 0.04. The median surgery satisfaction was good in both groups STx4 (95%, interquartile range (IQR): 90%–98%) and ST-G (98%, IQR: 95%–100%) (p = 0.13). Return to sport was 90% (n = 19) for the STx4 group and 81% (n = 17) for the ST-G group (p = 0.37). Quadriceps strength recovered sooner (6 months) than hamstrings (24 months) in both groups. There were no statistically significant differences in strength between STx4 and ST-G at final follow-up (hamstrings in flexion [mean ± SD]: 173 ± 53 N vs. 166 ± 51 N, p = 0.7; hamstrings in extension: 204 ± 61 N vs. 199 ± 64 N, p = 0.8; quadriceps in flexion: 217 ± 42 N vs. 209 ± 47 N, p = 0.6; quadriceps in extension: 193 ± 51 N vs. 191 ± 46 N, p = 0.9).

Conclusions

This study found no statistically significant differences at 2 years between a STx4 and a ST-G graft configuration for primary ACL reconstruction regarding strength, PROMs, return to sport, failure rates and complications; larger studies are required to confirm noninferiority. Clinical Trials number: NCT03433170.

Level of Evidence

Level I.

Abstract Image

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四重半腱肌和半腱肌-股薄肌移植重建前交叉韧带的结果相似：一项2年随访的随机对照试验

目的比较四重半腱肌（STx4）与半腱肌-股薄肌移植在前交叉韧带（ACL）重建手术中的应用。方法采用平行随机对照试验，分为两组（42例）进行原发性ACL重建手术。术后随访2年，分别于3、6、12、24个月就诊。主要指标：股四头肌和腘绳肌的力量(N)。次要结局：前交叉韧带再破裂、额外手术、恢复运动和患者报告的结局（PROMs）：膝关节损伤和骨关节炎结局评分（oos）、国际膝关节文献委员会（IKDC）和Tegner-Lysholm。结果STx4组ACL再破裂发生率为1/21，对照组为2/21 （p = 0.9）。每组增加一次手术：ACL翻修（对照组）和半月板切除术（STx4）。除3个月时的Tegner-Lysholm优于STx4组（76.0，可信区间[CI]: 56.0-86.0 vs. 85.0, CI: 77.0-93.0）， p = 0.04外，两组间无其他并发症，prom无差异。STx4组（95%，四分位差（IQR）： 90% ~ 98%）和ST-G组（98%,IQR: 95% ~ 100%）的中位手术满意度均较好（p = 0.13）。STx4组的运动恢复率为90% (n = 19)， ST-G组为81% (n = 17) （p = 0.37）。在两组中，股四头肌力量恢复的时间（6个月）都快于腘绳肌（24个月）。STx4和ST-G在最终随访时的力量差异无统计学意义（屈曲腘绳肌[mean±SD]: 173±53 N比166±51 N， p = 0.7；伸展腘绳肌：204±61 N比199±64 N， p = 0.8；屈曲股四头肌：217±42 N比209±47 N， p = 0.6；伸展股四头肌：193±51 N比191±46 N， p = 0.9）。结论：本研究发现STx4和ST-G移植物在2年后的强度、PROMs、恢复运动、失败率和并发症方面没有统计学上的显著差异；需要更大规模的研究来证实非劣效性。临床试验编号：NCT03433170。证据等级一级。

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