Joint Instability Clinical Trial
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 Observer-blinded, Parallel-design Trial
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])
n/a
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