Ignite Creation Date:
2024-05-05 @ 10:08 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01037738
Status:
COMPLETED
Last Update Posted:
2009-12-23
First Post:
2009-12-03
Brief Title:
Study of Autologous Conditioned Serum After Anterior Cruciate Ligament Reconstructive Surgery
Sponsor:
University of Zagreb
Organization:
University of Zagreb
Study Overview
Official Title:
Intraarticular Application of Autologous Conditioned Serum ACSOrthokine Reduces Bone Tunnel Widening After ACL Reconstructive Surgery A Prospective Randomized Saline-controlled Patient- and Observer-blinded Parallel-design Trial
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None