Clinical Trial: Study of Autologous Conditioned Serum After Anterior Cruciate Ligament Reconstructive Surgery
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Intraarticular Application of Autologous Conditioned Serum (ACS/Orthokine) Reduces Bone Tunnel Widening After ACL Reconstructive Surgery A Prospective, Randomized, Saline-controlled, Patient- and Obse
Brief Summary:
Abstract
Background
Pro-inflammatory cytokines play a pivotal role in osteoarthritis, as well as in bone tunnel widening after ACL reconstructive surgery. A new treatment option is to administer autologous conditioned serum (ACS) containing endogenous anti-inflammatory cytokines including IL-1Ra and growth factors (IGF-1, PDGF and TGF-ß1, among others) in the liquid blood phase.
Objective The purpose of this trial was to establish whether the osteoclastic effect could be affected by intra-articular application of ACS, thus resulting in a potential decrease of knee laxity and leading to a better postoperative outcome.
Methods In a prospective, randomized, double-blinded, placebo-controlled trial with two parallel groups, 62 patients were treated. Bone tunnel width was measured by CT scans, while clinical efficacy was assessed by patient-administered outcome instruments (WOMAC, IKDC 2000) up to one year following the ACL reconstruction in patients receiving either ACS (Group A) or placebo (Group B). The investigators compared the levels and dynamics of IL-1b concentrations in the synovial liquid and examined the correlation between the levels of IL-1b at three different post-operative points.
Level of evidence Therapeutic study, Level 1 (randomized controlled trial [significant differences and narrow confidence intervals])
Detailed Summary:
Sponsor: University of Zagreb
Current Primary Outcome: Bone tunnel width - CT scans. Clinical efficacy - patient administered outcome instruments (WOMAC, IKDC 2000). [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Measurements and correlation between the levels of synovial fluid IL-1b at three different post-operative points. [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: University of Zagreb
Dates:
Date Received: December 3, 2009
Date Started: May 2006
Date Completion:
Last Updated: December 22, 2009
Last Verified: January 2009
