NCT00719576

Brief Summary

The objective of this trial is to demonstrate superior efficacy and safety of MACI compared with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years) with symptomatic articular cartilage defects of the knee.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2008

Typical duration for phase_3

Geographic Reach
7 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

December 14, 2017

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

3.7 years

First QC Date

July 17, 2008

Results QC Date

January 12, 2017

Last Update Submit

May 10, 2021

Conditions

Articular Cartilage Defect

Keywords

Cartilage legionssymptomatic focal cartilage defectsmicrofractureMACIautologous chondrocyte

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to Week 104 for the Participant's Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain and Function (Sports and Recreational Activities) Scores.

    The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score.

    Baseline and Week 104

Secondary Outcomes (6)

  • Histological Evaluation of Structural Repair of Evaluable Biopsies Harvested From the Core of the Index Lesion During Arthroscopy at Week 104

    Week 104

  • Assessment of Defect Fill by Magnetic Resonance Imaging (MRI)

    Week 104

  • Response Rate Based on KOOS Pain and Function (Sports and Recreational Activities) Scores at Week 104.

    Week 104

  • Treatment Failure

    Week 104

  • Change From Baseline at Week 104 in the Remaining 3 Subscales of the KOOS Instrument (Activities of Daily Living, Knee-related Quality of Life, and Other Symptoms)

    Baseline and Week 104

  • +1 more secondary outcomes

Study Arms (2)

MACI

EXPERIMENTAL

autologous cultured chondrocytes on porcine collagen membrane

Biological: autologous cultured chondrocytes on porcine collagen membrane

Microfracture

ACTIVE COMPARATOR

Microfracture

Procedure: Microfracture

Interventions

autologous cultured chondrocytes on porcine collagen membraneBIOLOGICAL

Implantation via mini-arthrotomy

Also known as: MACI, matrix-applied characterized autologous cultured chondrocytes
MACI
MicrofracturePROCEDURE

Microfracture performed by arthroscopic surgery

Microfracture

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement

You may not qualify if:

  • Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
  • Severe osteoarthritis of the knee
  • Inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders
  • Prior knee surgery (within 6 months), excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Urazova nemocnice v Brne

Brno, Czechia

Location

Fakultni Nemocnice Na Bulovce

Prague, Czechia

Location

Fakultni Nemocnice v Motole

Prague, Czechia

Location

Hopital d'instruction des armees Robert Picque

Bordeaux, France

Location

Centre Hospitalier Lyon Sud

Lyon, France

Location

Polyclinique Saint-Roch

Montpellier, France

Location

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

Paris, France

Location

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

Location

St. Elisabeth Ziekenhuis

Tilburg, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

St Olavs Hospital

Trondheim, Norway

Location

Szpital Uniwersytecki

Bydgoszcz, Poland

Location

Regional Hospital of Traumatologic Surgery

Piekary Śląskie, Poland

Location

Center for Sports Medicine CMS

Warsaw, Poland

Location

Medical Academy Warsaw

Warsaw, Poland

Location

Kungsbacka Hospital

Kungsbacka, Sweden

Location

Capio Artro Clinic AB

Stockholm, Sweden

Location

The South West London Elective Orthopaedic Centre (SWLEOC)

Epsom, United Kingdom

Location

Nuffield Dept. of Orthopaedic Surgery, University of Oxford

Oxford, United Kingdom

Location

Spire Cheshire Hospital

Warrington, United Kingdom

Location

Related Publications (1)

  • Saris D, Price A, Widuchowski W, Bertrand-Marchand M, Caron J, Drogset JO, Emans P, Podskubka A, Tsuchida A, Kili S, Levine D, Brittberg M; SUMMIT study group. Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Two-Year Follow-up of a Prospective Randomized Trial. Am J Sports Med. 2014 Jun;42(6):1384-94. doi: 10.1177/0363546514528093. Epub 2014 Apr 8.

    PMID: 24714783RESULT

MeSH Terms

Conditions

Fractures, Stress

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Limitations and Caveats

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in clinical trials cannot be directly compared to rates in the clinical trials of another product and may not reflect the rates observed in practice.

Results Point of Contact

Title
Ann Remmers, Senior Director, Clinical Science
Organization
Vericel Corporation
aremmers@vcel.com
734-428-4526

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 21, 2008

Study Start

July 1, 2008

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 12, 2021

Results First Posted

December 14, 2017

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(3)NO(1)FR(4)PL(4)SE(2)CZ(3)GB(3)