Study of Autologous Conditioned Serum After Anterior Cruciate Ligament Reconstructive Surgery
Primary Purpose
Joint Instability
Status
Completed
Phase
Phase 1
Locations
Croatia
Study Type
Interventional
Intervention
ACL reconstructive surgery and ACS/ Orthokin application
Sponsored by
About this trial
This is an interventional treatment trial for Joint Instability focused on measuring ACL reconstruction, autologous conditioned serum, Orthokine, osteoarthritis, interleukin receptor antagonist, growth factors, WOMAC, IKDC
Eligibility 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.
Sites / Locations
- Medical School, University of Zagreb
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ACS - Orthokin
Placebo
Arm Description
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.
Physiologic solution
Outcomes
Primary Outcome Measures
Bone tunnel width - CT scans. Clinical efficacy - patient administered outcome instruments (WOMAC, IKDC 2000).
Secondary Outcome Measures
Measurements and correlation between the levels of synovial fluid IL-1b at three different post-operative points.
Full Information
NCT ID
NCT01037738
First Posted
December 3, 2009
Last Updated
December 22, 2009
Sponsor
University of Zagreb
Collaborators
Croatian Institute of Health Insurance
1. Study Identification
Unique Protocol Identification Number
NCT01037738
Brief Title
Study of Autologous Conditioned Serum After Anterior Cruciate Ligament Reconstructive Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zagreb
Collaborators
Croatian Institute of Health Insurance
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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])
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Instability
Keywords
ACL reconstruction, autologous conditioned serum, Orthokine, osteoarthritis, interleukin receptor antagonist, growth factors, WOMAC, IKDC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACS - Orthokin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Physiologic solution
Intervention Type
Procedure
Intervention Name(s)
ACL reconstructive surgery and ACS/ Orthokin application
Intervention Description
ACL reconstructive surgery and ACS/ Orthokin or Placebo intraarticular application on Day 0,1,6 and 10 postoperatively, regarding the Arm
Primary Outcome Measure Information:
Title
Bone tunnel width - CT scans. Clinical efficacy - patient administered outcome instruments (WOMAC, IKDC 2000).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Measurements and correlation between the levels of synovial fluid IL-1b at three different post-operative points.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Medical School, University of Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
12. IPD Sharing Statement
Citations:
Citation
References 1. Harris NL, Indelicato PA, Bloomberg MS, Meister K, Wheeler DL. Radiographic and histologic analysis of the tibial tunnel after allograft anterior cruciate ligament reconstruction in goats. American Journal of Sports Medicine 30 (3):368-73,2002. 2. Hoher J, Moller HD, Fu FH. Bone tunnel enlargement after anterior cruciate ligament reconstruction: fact or fiction? Knee Surgery, Sports Traumatology and Arthroscopy 6 (4):231-40,1998. 3. Hsu CJ, Hsu HC, Jim YF. A radiological study after anterior cruciate ligament reconstruction. Journal of Chinese Medical Association 66(3):160-5,2003. 4. Nakayama Y, Shirai Y, Narita T, Mori A. Enlargement of bone tunnels after anterior cruciate ligament reconstruction. Nippon Ika Daigaku Zasshi 65(5):377-81,1998. 5. Topliss C, Webb J. An audit of tunnel position in anterior cruciate ligament reconstruction. Knee 8(1):59-63,2001.
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Study of Autologous Conditioned Serum After Anterior Cruciate Ligament Reconstructive Surgery
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