A prospective comparison of 3 hamstring ACL fixation devices—rigidfix, bioscrew, and intrafix—randomized into 4 groups with a minimum follow-up of 5 years

Abstract

Background ACL (anterior cruciate ligament) reconstruction remains the gold standard surgical option for patients with ACL tears. There are many fixation devices available for ACL reconstruction. Recent ACL reconstruction strategies are aiming to reproduce the native anatomy and normal kinematics of the knee. This is a five years follow-up report of some of the new devices for graft fixation. A two years follow-up data was published previously. Methods 120 patients were randomized into four different groups (30 each) for ACL reconstruction with hamstring tendons: group I femoral Rigidfix cross-pin and Intrafix tibial extension sheath with a tapered expansion screw; group II Rigidfix femoral and BioScrew interference screw tibial fixation; group III BioScrew femoral and Intrafix tibial fixation; group IV BioScrew fixation into both tunnels. The evaluation methods were clinical examination, knee scores, and instrumented laxity measurements. Results In this 5 years follow-up there were 102/120 (85%) patients available, but only 77 (64,2%) attended the clinical examinations. No significant difference between the groups in the clinical results was detected. Between the 2 and 5 years follow-up there were 6 additional procedures in group I and one in group II. There was a significant difference in additional procedures between group I and the other groups (P = .041). Conclusion There was a statistically significant difference in the additional procedures, most in group I (six). The ACL grafts were intact. Other statistically or clinically significant differences in the 5 years follow-up results were not found. Study design Randomized controlled clinical trial; Level of evidence, 1. Trial registration ISRCTN registry with study ID ISRCTN34011837. Retrospectively registered 17.4.2020.

Outcomes of RigidFix Cross Pin Fixation in Femoral and Tibial Tunnel for Anterior Cruciate Ligament Reconstruction

“…Hence, the tibial tunnel fixation should be further studied. 24,25 Inspired by the successful application of RigidFix (DePuy Mitek, Raynham, MA, USA) in the femoral tunnel, 11 we applied RigidFix cross pins to the tibial tunnel in the hope of achieving large graft size and better clinical results.…”

“…Despite numerous clinical and biomechanical studies on the topic of tibial tunnel fixation, 22,23 there is no clear consensus as to which method of fixation is most favorable. Hence, the tibial tunnel fixation should be further studied 24,25 . Inspired by the successful application of RigidFix (DePuy Mitek, Raynham, MA, USA) in the femoral tunnel, 11 we applied RigidFix cross pins to the tibial tunnel in the hope of achieving large graft size and better clinical results.…”

Advanced strategies for constructing interfacial tissues of bone and tendon/ligament

“…Traditional surgical treatments for enthesis include the reconstruction of enthesis with broken tendon/ligament terminals. 11 – 13 This is achieved through: (a) direct insertion of the broken enthesis into the bone tunnel, (b) mechanical anchoring of the reconstructed tissue using sutures or screws, and (c) minimizing externally-loaded forces to avoid accidental loosening or re-rupture after surgery. 14 – 19 Because traditional surgical treatments mainly focus on reestablishing enthesis anatomy while overlooking enthesis tissue regeneration, their efficacy in enthesis repair is limited.…”