PURPOSE: The anterior cruciate ligament (ACL) reconstruction is one of the most performed and successful orthopaedic procedures. The results are considered independent by the choice of the graft and the fixation devices. A growing interest on resorbable non-metallic fixation devices versus standard metallic fixation devices has been noted over recent years with few clinical experiences reported in the literature. The aim of this study is to compare the clinical and radiological outcomes of patients undergoingACL reconstruction using autologous hamstring tendons with tibial fixation by a centrally placed resorbable screw and sheath to a combination of an eccentrically placed resorbable interference screw and supplementary staple fixation. METHODS:Ninety patients undergoing an isolated, single-bundle, primary ACL reconstruction with autologous hamstring tendons, using the same femoral fixation, were randomized to a tibial fixation with a centrally placed resorbable screw and sheath, BioIntrafix (group A), or an eccentrically placed resorbable interference screw, BioRCI, and two non-resorbable staples (group B). The latter has represented for many years our standard fixation method. Clinical evaluations (KOOS, IKDC, KT-2000™ side-to-side difference) and radiological analyses were conducted in both groups with a minimum follow-up of 2 years. RESULTS: We assisted in a satisfactory pain relief and functional improvements, without significant clinical and radiological differences in both groups. No further surgery was needed in patients with the screw/sheath tibial fixation. Seven patients with thescrew/staples tibial fixation needed the surgical removal of the fixation devices due to pes anserinus irritation or local infection years after the index operation. Other parameters such as the tunnel enlargement were not statistically different in the two groups. CONCLUSIONS: Good clinical and radiological outcomes of ACL reconstruction by a screw/sheath tibial fixation have been reported showing comparable results with respect to screw/staples fixation. There were no failures associated with loss of fixation with either of tibial fixation methods. A fewer number of surgical removals of tibial devices were also recorded in patients treated by the screw/sheath fixation system, related to the absence of local intolerance or infection compared to subjects with a standard tibial fixation.
RCT Entities:
PURPOSE: The anterior cruciate ligament (ACL) reconstruction is one of the most performed and successful orthopaedic procedures. The results are considered independent by the choice of the graft and the fixation devices. A growing interest on resorbable non-metallic fixation devices versus standard metallic fixation devices has been noted over recent years with few clinical experiences reported in the literature. The aim of this study is to compare the clinical and radiological outcomes of patients undergoing ACL reconstruction using autologous hamstring tendons with tibial fixation by a centrally placed resorbable screw and sheath to a combination of an eccentrically placed resorbable interference screw and supplementary staple fixation. METHODS: Ninety patients undergoing an isolated, single-bundle, primary ACL reconstruction with autologous hamstring tendons, using the same femoral fixation, were randomized to a tibial fixation with a centrally placed resorbable screw and sheath, BioIntrafix (group A), or an eccentrically placed resorbable interference screw, BioRCI, and two non-resorbable staples (group B). The latter has represented for many years our standard fixation method. Clinical evaluations (KOOS, IKDC, KT-2000™ side-to-side difference) and radiological analyses were conducted in both groups with a minimum follow-up of 2 years. RESULTS: We assisted in a satisfactory pain relief and functional improvements, without significant clinical and radiological differences in both groups. No further surgery was needed in patients with the screw/sheath tibial fixation. Seven patients with the screw/staples tibial fixation needed the surgical removal of the fixation devices due to pes anserinus irritation or local infection years after the index operation. Other parameters such as the tunnel enlargement were not statistically different in the two groups. CONCLUSIONS: Good clinical and radiological outcomes of ACL reconstruction by a screw/sheath tibial fixation have been reported showing comparable results with respect to screw/staples fixation. There were no failures associated with loss of fixation with either of tibial fixation methods. A fewer number of surgical removals of tibial devices were also recorded in patients treated by the screw/sheath fixation system, related to the absence of local intolerance or infection compared to subjects with a standard tibial fixation.
Authors: Gauti Laxdal; Jüri Kartus; Bengt I Eriksson; Eva Faxén; Ninni Sernert; Jon Karlsson Journal: Am J Sports Med Date: 2006-05-09 Impact factor: 6.202
Authors: Peter N Chalmers; Nathan A Mall; Mario Moric; Seth L Sherman; George P Paletta; Brian J Cole; Bernard R Bach Journal: J Bone Joint Surg Am Date: 2014-02-19 Impact factor: 5.284