Jan von Recum1, Julia Gehm1, Thorsten Guehring2, Sven Y Vetter1, Philipp von der Linden1, Paul-Alfred Grützner1, Marc Schnetzke3. 1. Department for Trauma and Orthopaedic Surgery, BG Trauma Center Ludwigshafen, University of Heidelberg, Ludwigshafen on the Rhine, Germany. 2. Department for Shoulder and Elbow Surgery, Arcus Clinic Pforzheim, Pforzheim, Germany. 3. Department for Trauma and Orthopaedic Surgery, BG Trauma Center Ludwigshafen, University of Heidelberg, Ludwigshafen on the Rhine, Germany. Electronic address: marcschnetzke@gmx.de.
Abstract
PURPOSE: To compare and evaluate knee laxity and functional outcomes between autologous bone graft and silicate-substituted calcium phosphate (Si-CaP) in the treatment of tunnel defects in 2-stage revision anterior cruciate ligament reconstruction (ACLR). METHODS: This prospective, randomized controlled trial was conducted between 2012 and 2015 with a total of 40 patients who underwent 2-stage revision ACLR. The tunnels were filled with autologous iliac crest cancellous bone graft in 20 patients (control group) and with Si-CaP in the other 20 patients (intervention group). After a minimum follow-up period of 2 years, functional outcomes were assessed by KT-1000 arthrometry (side-to-side [STS] difference), the Tegner score, the Lysholm score, and the International Knee Documentation Committee score. RESULTS: A total of 37 patients (follow-up rate, 92.5%) with an average age of 31 years were followed up for 3.4 years (range, 2.2-5.5 years). The KT-1000 measurement did not show any STS difference between the bone graft group (0.9 ± 1.5 mm) and the Si-CaP group (0.7 ± 2.0 mm) (P = .731). One patient in the intervention group (5%) had an STS difference greater than 5 mm. Both groups showed significant improvements in the Tegner score, Lysholm score, and International Knee Documentation Committee score from preoperative assessment to final follow-up (P ≤ .002), without any difference between the 2 groups (P ≥ .396). Complications requiring revision occurred in 4 control patients (22%) and in 2 patients in the intervention group (11%) (P = .660). No complications in relation to Si-CaP were observed. CONCLUSIONS:Equivalent knee laxity and clinical function outcomes were noted 3 years after surgery in both groups of patients. Si-CaP bone substitute is therefore a safe alternative to autologous bone graft for 2-stage ACLR. LEVEL OF EVIDENCE: Level I, prospective, randomized controlled clinical trial.
RCT Entities:
PURPOSE: To compare and evaluate knee laxity and functional outcomes between autologous bone graft and silicate-substituted calcium phosphate (Si-CaP) in the treatment of tunnel defects in 2-stage revision anterior cruciate ligament reconstruction (ACLR). METHODS: This prospective, randomized controlled trial was conducted between 2012 and 2015 with a total of 40 patients who underwent 2-stage revision ACLR. The tunnels were filled with autologous iliac crest cancellous bone graft in 20 patients (control group) and with Si-CaP in the other 20 patients (intervention group). After a minimum follow-up period of 2 years, functional outcomes were assessed by KT-1000 arthrometry (side-to-side [STS] difference), the Tegner score, the Lysholm score, and the International Knee Documentation Committee score. RESULTS: A total of 37 patients (follow-up rate, 92.5%) with an average age of 31 years were followed up for 3.4 years (range, 2.2-5.5 years). The KT-1000 measurement did not show any STS difference between the bone graft group (0.9 ± 1.5 mm) and the Si-CaP group (0.7 ± 2.0 mm) (P = .731). One patient in the intervention group (5%) had an STS difference greater than 5 mm. Both groups showed significant improvements in the Tegner score, Lysholm score, and International Knee Documentation Committee score from preoperative assessment to final follow-up (P ≤ .002), without any difference between the 2 groups (P ≥ .396). Complications requiring revision occurred in 4 control patients (22%) and in 2 patients in the intervention group (11%) (P = .660). No complications in relation to Si-CaP were observed. CONCLUSIONS: Equivalent knee laxity and clinical function outcomes were noted 3 years after surgery in both groups of patients. Si-CaP bone substitute is therefore a safe alternative to autologous bone graft for 2-stage ACLR. LEVEL OF EVIDENCE: Level I, prospective, randomized controlled clinical trial.