search
Back to results

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
University of Zagreb
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 3, 2009
Last Updated
December 22, 2009
Sponsor
University of Zagreb
Collaborators
Croatian Institute of Health Insurance
search

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.
Results Reference
background

Learn more about this trial

Study of Autologous Conditioned Serum After Anterior Cruciate Ligament Reconstructive Surgery

We'll reach out to this number within 24 hrs