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Study of Autologous Conditioned Serum After Anterior Cruciate Ligament Reconstructive Surgery

This study has been completed.
Sponsor:
Collaborator:
Croatian Institute of Health Insurance
Information provided by:
University of Zagreb
ClinicalTrials.gov Identifier:
NCT01037738
First received: December 3, 2009
Last updated: December 22, 2009
Last verified: January 2009
History of Changes
  Purpose

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])


Condition Intervention Phase
Joint Instability
 Procedure: ACL reconstructive surgery and ACS/ Orthokin application
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zagreb:

Primary Outcome Measures:
  • Bone tunnel width - CT scans. Clinical efficacy - patient administered outcome instruments (WOMAC, IKDC 2000). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurements and correlation between the levels of synovial fluid IL-1b at three different post-operative points. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: May 2006
Study Completion Date: January 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ACS - Orthokin
Autologous conditioned serum (ACS) - Orthokin containing endogenous anti-inflammatory cytokines including IL-1Ra and growth factors (IGF-1, PDGF and TGF-ß1, among others) in the liquid blood phase.
 Procedure: ACL reconstructive surgery and ACS/ Orthokin application
ACL reconstructive surgery and ACS/ Orthokin or Placebo intraarticular application on Day 0,1,6 and 10 postoperatively, regarding the Arm
Placebo Comparator: Placebo
Physiologic solution
 Procedure: ACL reconstructive surgery and ACS/ Orthokin application
ACL reconstructive surgery and ACS/ Orthokin or Placebo intraarticular application on Day 0,1,6 and 10 postoperatively, regarding the Arm

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligible patients were:

  • older than 18 years
  • prior to each surgery, traumatic ACL rupture was determined on the basis of a clinical examination and confirmed by exploratory and therapeutic arthroscopic surgery in accordance with good surgical practice
  • the same preoperative diagnosis of isolated ACL rupture
  • a knee axis deviation up to 5°; knee osteoarthritis up to grade 1 according to the AO
  • knee chondral lesion up to grade 2 (Outerbridge classification).

Exclusion Criteria:

  • poor general health as judged by the orthopedic surgeon
  • Concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee
  • Any clinically significant or symptomatic vascular or neurological disorder; crystalline, inflammatory and infectious arthropathies
  • Infections
  • Osteomyelitis
  • Alcohol/drug abuse
  • Known coagulopathy
  • Corticosteroid or anti-coagulant usage, and morbid obesity.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037738

Locations
Croatia
Medical School, University of Zagreb
Zagreb, Croatia, 10000
Sponsors and Collaborators
University of Zagreb
Croatian Institute of Health Insurance
  More Information

No publications provided

Responsible Party: Nikica Darabos, MD PhD, University Clinic for Traumatology, Draskoviceva 19, 10000 Zagreb, Croatia
ClinicalTrials.gov Identifier: NCT01037738     History of Changes
Other Study ID Numbers: REC LCA 2B
Study First Received: December 3, 2009
Last Updated: December 22, 2009
Health Authority: Croatia: Ministry of Science, Education and Sports

Keywords provided by University of Zagreb:
ACL reconstruction
autologous conditioned serum
Orthokine
osteoarthritis
 interleukin receptor antagonist
growth factors
WOMAC
IKDC

Additional relevant MeSH terms:
Joint Instability
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 19, 2013