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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00719576
First received: July 17, 2008
Last updated: January 3, 2013
Last verified: January 2013
  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 (MACI®) Versus Arthroscopic Microfracture for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea.

Further study details as provided by Genzyme, a Sanofi Company:

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 ]
    Evaluation of histological data will be performed by independent central review blinded to the patient's treatment. An appropriate histological evaluation score will be used to assess the structural repair.

  • MRI (magnetic resonance imaging) Assessment of structural repair parameters. [ Time Frame: At Baseline, week 52, and week 104 ] [ Designated as safety issue: No ]

    Including:

    • Degree of defect fill based on the thickness of repair tissue
    • Degree of integration of the repair tissue with adjacent native cartilage
    • Signal intensity of the repair tissue relative to adjacent native cartilage

  • 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 ]
    A responder is defined as a patient with at least a 10-point improvement in both the KOOS Pain and Function (Sports and Recreational activities) scores from Baseline (Roos, 2003, Health Qual Life Outcomes).

  • Treatment failure rate at week 104. [ Time Frame: week 104 ] [ Designated as safety issue: No ]
    The proportion of patients in each treatment group assessed as treatment failures.

  • Change from Baseline at Week 104 in the remaining 3 subscales of the KOOS instrument [ Time Frame: week 104 ] [ Designated as safety issue: No ]
    Three subscales - other Symptoms, Knee-Related Quality of Life, Activities of Daily Living.

  • Participants with Adverse Events [ Time Frame: week 104 ] [ Designated as safety issue: Yes ]
    • Rate of treatment-emergent AEs.
    • Rate of serious adverse events (SAEs).
    • Rate of subsequent surgical procedures (SSPs).


Other Outcome Measures:
  • Change from Baseline in all 5 subscales of the KOOS instrument (i.e., Pain, other Symptoms, Knee-related Quality of Life, Activities of Daily Living, Sports/Recreation). [ Time Frame: weeks 24, 36, 52, and 78 ] [ Designated as safety issue: No ]
  • Response rate based on KOOS Pain and Function (Sports and Recreational activities) scores [ Time Frame: weeks 24, 36, 52 and 78. ] [ Designated as safety issue: No ]
    The proportion of patients who responded to treatment

  • Treatment failure rate [ Time Frame: weeks 24, 36, 52, and 78. ] [ Designated as safety issue: No ]
    The proportion of patients in each treatment group assessed as treatment failures.

  • Average time to treatment failure [ Time Frame: week 104 ] [ Designated as safety issue: No ]
    The time to treatment failure will be based on the date that the surgeon decides that surgical re treatment of the original index lesion is required relative to the date of the original study surgery (i.e., arthroscopy for microfracture and arthrotomy for MACI implant). Treatment failure is only determined in relation to the original treated defect(s).

  • Change from Baseline in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System [ Time Frame: weeks 52 and 104 ] [ Designated as safety issue: No ]
  • Change from Baseline in the patient's evaluation of overall knee condition using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form. [ Time Frame: weeks 52 and 104 ] [ Designated as safety issue: No ]
  • Change from Baseline in the 12-Item Short-Form Health Survey (SF-12) [ Time Frame: weeks 52 and 104 ] [ Designated as safety issue: No ]
    Acute Version 2.0 for the 8 subscales (physical functioning, role-physical, bodily pain, general health, vitality, social function, role-emotional, mental health), and the physical and mental summary components.

  • Change from Baseline in the European Quality of Life (EuroQOL) 5 dimensions (EQ-5D) health state. [ Time Frame: weeks 52 and 104 ] [ Designated as safety issue: No ]
  • Macroscopic International Cartilage Repair Society (ICRS) "Cartilage Repair Assessment" score during arthroscopy at Week 104 in patients undergoing arthroscopy for harvesting of biopsy of the index lesion [ Time Frame: week 104 ] [ Designated as safety issue: No ]

Enrollment: 144
Study Start Date: July 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MACI
Matrix-Induced Autologous Chondrocyte Implant
Biological: Matrix-Induced Autologous Chondrocyte Implant (MACI)
Implantation
Active Comparator: Microfracture
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).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719576

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
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00719576     History of Changes
Other Study ID Numbers: MACI00206, 2006-004817-16
Study First Received: July 17, 2008
Last Updated: January 3, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Czech Republic: State Institute for Drug Control
Sweden: Medical Products Agency
Netherlands: Ministry of Health, Welfare and Sport
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Genzyme, a Sanofi Company:
Cartilage legions,
symptomatic focal cartilage defects,
microfracture,
MACI,
autologous chondrocyte

Additional relevant MeSH terms:
Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 31, 2014