Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

RCT of ChondroCelect® (in an ACI Procedure) vs Microfracture in the Repair of Cartilage Defects of the Knee

Lead Sponsor:

TiGenix n.v.

Conditions:

Articular Cartilage Lesion of the Femoral Condyle

Eligibility:

All Genders

18-50 years

Phase:

PHASE3

Brief Summary

This is a phase III, multicenter, open-label, randomized controlled trial of ChondroCelect® in an Autologous Chondrocyte Implantation (ACI) procedure compared to the procedure of microfracture (MF) in...

Detailed Description

see above

Eligibility Criteria

Inclusion

  • Signed patient informed consent
  • Symptomatic cartilage single lesion of the femoral condyle
  • Lesion on femoral condyle between 1 and 5 cm²
  • Agree to participate actively in a strict rehabilitation protocol and follow-up programme
  • Agree to only use paracetamol mono-or combination preparation (max 4g/d) and Non-Steroidal Anti Inflammatory Drugs (NSAIDS) during the study and to discontinue this medication 2 weeks before the baseline visit and the follow-up visits. The use of paracetamol mono-preparation (max 4g/d) is allowed up to one week before the baseline visit and the follow-up visits.
  • Females of childbearing age should use a proven method to prevent pregnancy

Exclusion

  • Participation in concurrent trials
  • Participation in previous trials within 3 months
  • Subjects with hepatitis, HIV or syphilis
  • Malignancy
  • Alcohol or drug (medication) abuse
  • Poor general health as judged by Investigator
  • Clinically relevant second cartilage lesion on the patella
  • Patellofemoral cartilage lesion
  • Osteochondritis Dissecans (OCD) : recent OCD (within 1 year before baseline), depth of lesion \> 0.5cm, subchondral slerosis
  • Advanced osteoarthritis (OA) : radiographic atlas of OA grade 2-3
  • Known allergy to gentamicin or penicillins (or presence of multiple severe allergies)
  • Complex ligamentous instability of the knee
  • Meniscal transplant
  • Meniscal suture with meniscal arrows (ipsilateral)
  • Meniscus resection : if \< 1 yr before baseline - lateral meniscus resection or medial meniscus resection of more than 50%. If \> 1 yr before baseline - ipsilateral meniscus resection of more than 50%, controlateral meniscus resection of more than 50% if ipsilateral meniscus is not intact, combination of medial and lateral meniscus resection and one of both \> 50%.
  • Varus or valgus malalignment of more than 5°
  • Mosaicplasty
  • Microfracture performed less than 1 yr before baseline
  • Having received hyaluronic acid intra-articular injections in the affected knee within the last 6 months of baseline
  • Taking specific OA drugs such as chondroïtin sulfate, diacerein, n-glucosamine, piascledine, capsaicin within 2 weeks of the baseline visit
  • Corticosteroïd treatment by systemic or intra-articular route within the last month of baseline or intramuscular or oral corticosteroïds within the last 2 weeks of baseline
  • Chronic use of anticoagulants
  • Uncontrolled diabetes
  • Any 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 neurologic disorder of the lower extremities
  • Any evidence of the following diseases in the target joint : septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget's disease of bone, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders, collagen gene mutation
  • Current diagnosis of osteomyelitis
  • Liver enzymes (SGOT, SGPT, Alkaline Phosphatase) of more then two times the upper limit of normal or any other result that is clinically important according to the Investigator
  • CRP \> 10 mg/l

Key Trial Info

Start Date :

February 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2010

Estimated Enrollment :

118 Patients enrolled

Trial Details

Trial ID

NCT00414700

Start Date

February 1 2002

End Date

January 1 2010

Last Update

September 26 2011

Active Locations (12)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (12 locations)

1

AZ St. Jan Brugge, Department of Orthopedics

Bruges, Belgium, 8000

2

AZ St Lucas Brugge, Department of Orthopedics

Bruges, Belgium, 8310

3

Academisch Ziekenhuis, Vrije Universiteit Brussel, Department of Orthopedics

Brussels, Belgium, 1090

4

SPM Monica Antwerp

Deurne, Belgium, 2100