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A Comparison Between the Performance of Chondrocytes Versus Microfracture Technique on Knee Symptoms

This study has been completed.

Sponsored by: Genzyme
Information Provided By: Genzyme
Clinicaltrials.gov Identifier: NCT00719576

Purpose:

The objective of this trial is to investigate how the outcome of the treatment with autologous chondrocytes compares to microfracture technique in patients with symptomatic knee disease.

Condition: Intervention: Phase:
Repair of Articular Cartilage Defects
Biological: Matrix-Induced Autologous Chondrocyte Implant (MACI)
Procedure: Microfracture
Phase 3

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Official Title: A Prospective Randomized Open-label Parallel-group Multi-center Study to Demonstrate the Superiority of Matrix-induced Autologous Chondrocyte Implantation (MACIĀ®) Versus Arthroscopic Microfracture for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea.

Further Study Details:

Primary outcome measures:

  • Change from Baseline to week 104 for the patient's Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain and Function (Sports and Recreational activities) scores. [Time Frame: week 104] [Designated as safety issue: No]

Secondary outcome measures:

  • Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at week 104. [Time Frame: week 104] [Designated as safety issue: No]
  • MRI (magnetic resonance imaging) Assessment of structural repair parameters. [Time Frame: At Baseline, week 52, and week 104] [Designated as safety issue: No]
  • Response rate based on KOOS Pain and Function (Sports and Recreational activities) scores at week 104. [Time Frame: week 104] [Designated as safety issue: No]
  • Treatment failure rate at week 104. [Time Frame: week 104] [Designated as safety issue: No]
  • Change from Baseline at Week 104 in the remaining 3 subscales of the KOOS instrument [Time Frame: week 104] [Designated as safety issue: No]
  • Participants with Adverse Events [Time Frame: week 104] [Designated as safety issue: Yes]

Enrollment: 144

Study Start Date: July 2008

Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

ArmsInterventions
MACI: Experimental

Matrix-Induced Autologous Chondrocyte Implant    
Biological: Matrix-Induced Autologous Chondrocyte Implant (MACI)
    Implantation
Microfracture: Active Comparator

Microfracture    
Procedure: Microfracture
    Microfracture

Detailed Description:

This is a prospective, randomized, open-label, parallel-group, multicenter study designed to investigate the outcome of MACI implant versus arthroscopic microfracture in the treatment of articular cartilage defects in the knee in patients between ages of 18 and 55 years. All patients who meet the eligibility criteria and are considered suitable for inclusion will have a cartilage biopsy taken prior to randomization to study treatment. Eligible patients will then be randomized during the index arthroscopy procedure to receive either MACI implant or microfracture treatment. Patients randomized to treatment with MACI implant will return within approximately 4 to 8 weeks of the index arthroscopy to undergo the chondrocyte implantation procedure via arthrotomy. Patients randomized to microfracture will undergo the procedure during the index arthroscopy. Patients will be assessed post-arthroscopy and post-arthrotomy at intervals during 2 years follow-up. Evaluations include adverse events, functional and pain outcomes, arthroscopic and histologic evaluation and magnetic resonance imaging (MRI).

Accepts healthy volunteers: No

Eligibility

Ages eligible for study: 18 Years - 55 Years

Genders available for study: Both

Inclusion Criteria:



  • Patients with symptomatic articular cartilage defects in the knee.

Exclusion Criteria:


  • Patients who have had surgery on the knee joint within 6 months prior to enrollment.

  • Patients with significant malalignment.

  • Patients with instability of the knee.

  • Patients with the majority of functional meniscus absent or severe osteoarthritis in the target knee.

Locations:

Czech Republic
Urazova nemocnice v Brne
Brno, Czech Republic

Fakultni Nemocnice Na Bulovce
Prague, Czech Republic

Fakultni Nemocnice v Motole
Prague, Czech Republic

France
Hopital d'instruction des armees Robert Picque
Bordeaux, France

Centre Hospitalier Lyon Sud
Lyon, France

Polyclinique Saint-Roch
Montpellier, France

Chirurgien Orthopediste et Traumatologue du Sport, Institut de I'Appareil Locomoteur Nollet
Paris, France

Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands

St. Elisabeth Ziekenhuis
Tilburg, Netherlands

UMC Utrecht
Utrecht, Netherlands

Norway
St Olavs Hospital
Trondheim, Norway

Poland
Szpital Uniwersytecki
Bydgoszcz, Poland

Regional Hospital of Traumatologic Surgery
Piekary Slaskie, Poland

Medical Academy Warsaw
Warsaw, Poland

Center for Sports Medicine CMS
Warsaw, Poland

Sweden
Kungsbacka Hospital
Kungsbacka, Sweden

Capio Artro Clinic AB
Stockholm, Sweden

United Kingdom
The South West London Elective Orthopaedic Centre (SWLEOC)
Epsom, United Kingdom

Nuffield Dept. of Orthopaedic Surgery, University of Oxford
Oxford, United Kingdom

Spire Cheshire Hospital
Warrington, United Kingdom

Sponsor:

Genzyme

More Information

Study ID Numbers: MACI00206
ClinicalTrials.gov Identifier: NCT00719576
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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