Study of Autologous Conditioned Serum After Anterior Cruciate Ligament Reconstructive Surgery
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])
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Joint Instability
Intervention
ACL reconstructive surgery and ACS/ Orthokin application
Location
Medical School, University of Zagreb
Zagreb
Croatia
10000
Status
Completed
Source
University of Zagreb
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01037738
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:17:06-0400
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Medical and Biotech [MESH] Definitions
Joint Instability
Lack of stability of a joint or joint prosthesis. Factors involved are intra-articular disease and integrity of extra-articular structures such as joint capsule, ligaments, and muscles.
Tissue Expansion
A procedure whereby the body is stimulated to generate extra soft tissue by the application of stretching forces that stimulate new growth of tissue which, over a period of time, results in a 2-dimensional expansion of the tissue. The procedure is used in reconstructive surgery for injuries caused by trauma, burns, or ablative surgery. Various types of TISSUE EXPANSION DEVICES have been developed that exert stretching forces.
Arthropathy, Neurogenic
Chronic progressive degeneration of the stress-bearing portion of a joint, with bizarre hypertrophic changes at the periphery. It is probably a complication of a variety of neurologic disorders, particularly TABES DORSALIS, involving loss of sensation, which leads to relaxation of supporting structures and chronic instability of the joint. (Dorland, 27th ed)
Rotator Cuff Tear Arthropathy
Rapidly destructive shoulder joint and bone disease found mainly in elderly, and predominantly in women. It is characterized by SHOULDER PAIN; JOINT INSTABILITY; and the presence of crystalline CALCIUM PHOSPHATES in the SYNOVIAL FLUID. It is associated with ROTATOR CUFF INJURIES.
Mucopolysaccharidosis Iv
Genetic disorder of mucopolysaccharide metabolism characterized by skeletal abnormalities, joint instability, development of cervical myelopathy, and excessive urinary keratan sulfate. There are two biochemically distinct forms, each due to a deficiency of a different enzyme.
