Superiority of MACI® Versus Microfracture Treatment in Patients With Symptomatic Articular Cartilage Defects in the Knee (SUMMIT)

May 10, 2021 updated by: Vericel Corporation

A Prospective, Randomized, Open-label, Parallel-group, Multi-center Study to Demonstrate the Superiority of MACI® Versus Arthroscopic Microfracture for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia
        • Urazova nemocnice v Brne
      • Prague, Czechia
        • Fakultni nemocnice v Motole
      • Prague, Czechia
        • Fakultni nemocnice Na Bulovce
  • France
      • Bordeaux, France
        • Hôpital d'Instruction des Armées Robert Picqué
      • Lyon, France
        • Centre Hospitalier Lyon Sud
      • Montpellier, France
        • Polyclinique Saint-Roch
      • Paris, France
        • Chirurgien Orthopediste et Traumatologue du Sport, Institut de I'Appareil Locomoteur Nollet
  • Netherlands
      • Maastricht, Netherlands
        • Academisch Ziekenhuis Maastricht
      • Tilburg, Netherlands
        • St. Elisabeth Ziekenhuis
      • Utrecht, Netherlands
        • UMC Utrecht
  • Norway
      • Trondheim, Norway
        • St Olavs hospital
  • Poland
      • Bydgoszcz, Poland
        • Szpital Uniwersytecki
      • Piekary Slaskie, Poland
        • Regional Hospital of Traumatologic Surgery
      • Warsaw, Poland
        • Center for Sports Medicine CMS
      • Warsaw, Poland
        • Medical Academy Warsaw
  • Sweden
      • Kungsbacka, Sweden
        • Kungsbacka Hospital
      • Stockholm, Sweden
        • Capio Artro Clinic AB
  • United Kingdom
      • Epsom, United Kingdom
        • The South West London Elective Orthopaedic Centre (SWLEOC)
      • Oxford, United Kingdom
        • Nuffield Dept. of Orthopaedic Surgery, University of Oxford
      • Warrington, United Kingdom
        • Spire Cheshire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MACI
autologous cultured chondrocytes on porcine collagen membrane
Biological: autologous cultured chondrocytes on porcine collagen membrane
Implantation via mini-arthrotomy
Other Names:
  • MACI
  • matrix-applied characterized autologous cultured chondrocytes
Active Comparator: Microfracture
Procedure: Microfracture
Microfracture performed by arthroscopic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Baseline and Week 104
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

The mean microscopic International Cartilage Repair Society (ICRS) II overall assessment score was used to assess the histology efficacy endpoint.

Scoring of the cartilage repair biopsies was completed using the ICRS II histology scoring system (Mainil-Varlet, 2010, Am J Sports Med) by 2 independent pathologists blinded to the patient's assigned study treatment. This scoring system includes 14 parameters, comprising an overall assessment score reported here, as well as 13 other items related to chondrocyte phenotype, tissue structure, and other factors, each scored on a scale from 0 to 100 representing poor to good quality cartilage.
Week 104
Assessment of Defect Fill by Magnetic Resonance Imaging (MRI)
Time Frame: Week 104

Number of participants with MRI degree of defect fill > 50%. Evaluation of MRI data was performed by independent central review blinded to the participant's treatment.

Appropriate MRI sequences were used to image cartilage repair tissue.
Week 104
Response Rate Based on KOOS Pain and Function (Sports and Recreational Activities) Scores at Week 104.
Time Frame: Week 104
A responder is defined as a participant with at least a 10-point improvement in both the KOOS Pain and Function (Sports and Recreational activities) scores from Baseline
Week 104
Treatment Failure
Time Frame: Week 104

The planned analyses concerning time to treatment failure were not conducted due to the small number of per protocol treatment failure cases. As such, the number of participants with treatment failure is being reported.

Patients were considered as a treatment failure if all of the following 5 criteria were met:

  1. Patient's global assessment of their knee joint compared to Baseline was the same or worse
  2. Physician's global assessment of the patient's knee joint compared to Baseline was the same, worse, or significantly worse.
  3. Percent improvement from Baseline in KOOS Pain score was less than 10%.
  4. Physician diagnostic evaluation of failure excluded etiologies (eg, meniscal tear) other than failed treatment of the index lesion.
  5. The physician decided that surgical re-treatment of the index lesion(s) was required that involved either extensive debridement for lesion expansion, violation of the subchondral bone, or autologous cultured chondrocyte implantation.
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)
Time Frame: Baseline and Week 104
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).
Baseline and Week 104
Participants With Treatment-Emergent Adverse Events
Time Frame: Week 104
Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vericel Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

July 17, 2008

First Submitted That Met QC Criteria

July 18, 2008

First Posted (Estimate)

July 21, 2008

Study Record Updates

Last Update Posted (Actual)

May 12, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MACI00206
  • 2006-004817-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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