Randomized comparative study of suspension femoral fixation device in graft position maintenance in anterior cruciate ligament reconstruction: EndoButton CL vs TightRope RT

Abstract

Background In double-bundle anterior cruciate ligament reconstruction (ACLR), fixed-loop and adjustable-loop cortical suspensory devices are commonly used to fix the soft graft on the femoral side. However, few studies have compared in vivo elongation of the two devices. The purpose of this study was to determine whether EndoButton CL (EB) and TightRope RT (TR), the suspensory fixation devices used in ACLR, maintained their length in vivo from the time of surgery through the postoperative period in a randomized controlled trial. Methods This study prospectively incorporated 30 patients undergoing initial ACLR at a single center. Participants were divided into two groups using a stratified randomization method with age and sex as assignment adjustment factors. EB or TR was used for fixation of the soft graft on the femoral side. The primary endpoint was to compare the elongation distance of the suspensory device. MRIs were taken within seven days after ACLR and 3,6,12 months postoperatively and measured by a radiologist in a blinded fashion. Secondary endpoints included the side-to-side difference in anterior translation, one leg hop test (HOP index), Lachman test, lateral pivot shift test, and Lysholm score one year postoperatively. Results Twenty-eight patients (EB, n = 13; TR, n = 15) were followed for one year. There was no significant difference between EB and TR groups in elongation from the immediate postoperative period to 3, 6, 12 months after surgery. However, the non-inferiority of TR to EB (non-inferiority margin: 1.5 mm) was not proved by the difference in measured elongation between the two groups (TR – EB, lower 95% CI. AM: 1.80 mm; PL: 1.86 mm) at 6 months. There was no significant difference in anterior translation, HOP index, Lachman test, lateral pivot shift test, or Lysholm score. Conclusion EB and TR had similar graft retaining ability in vivo for 12 months, but the non-inferiority of TR against EB was not verified statistically.

Adjustable-loop implants are non-inferior to fixed-loop implants for femoral fixation in anterior cruciate ligament reconstruction

“…In this study, the ALDs showed a significantly lower risk of a positive pivot shift test at the 1‐year follow‐up compared with the FLDs. Most previous studies have found no statistical difference in pivot shift between FLD and ALDs [2, 3, 27, 36, 44]. However, Choi et al [11] found that FLDs had better stability in pivot shift compared with ALDs, which contradicts the findings of this study.…”

“…Clinical studies have found no difference between ALDs and FLDs in knee stability and patient‐reported outcomes. However, these studies were conducted with small patient populations [3, 5, 8, 11, 17, 27, 36, 39, 50]. Previous studies that compared the rates of revision surgery between ALDs and FLDs found no differences.…”

Fixed-loop vs. adjustable-loop cortical button devices for femoral fixation in ACL reconstruction – a systematic review and meta-analysis

“…A total of 15 studies were included in this systematic review [ 1 , 3 – 5 , 9 , 11 , 14 , 25 , 28 , 31 , 33 , 34 , 36 , 41 , 43 ]. All studies were screened in full text.…”

“…Five studies reported the PROMs with the Lysholm score at the 1-year follow-up [ 25 , 28 , 31 , 33 , 36 ] and seven studies reported them at the 2-years follow-up [ 1 , 2 , 9 , 11 , 14 , 34 , 41 ] (Table 4 ). The meta-analysis for the 2-years Lysholm scores revealed an overall MD in the Lysholm score of 0.17 points (95% CI: -040 – 0.75) higher for the ALD group compared to the FLD group (Fig.…”

“…Therefore, the rate of revision surgery is an important outcome when evaluating if ALDs are as safe to use in ACLR as FLDs. New clinical studies that include revision rates have been published in recent years [ 11 , 28 , 31 , 43 ]. These studies may allow for conducting a meta-analysis that has hitherto been difficult due to heterogeneity between studies.…”