Extension Study for Participants of MACI00206 Study of MACI® for the Treatment of Symptomatic Articular Cartilage Defects of the Knee

NCT01251588 | Completed Results

• 2 other identifiers: MACI008092009-016970-33
• Study Type: observational
• Target: 128
• Locations: 7 countries
• Sites: 14

Brief Summary

To examine the 5-year efficacy and safety of MACI implant, compared with arthroscopic microfracture, in participants who received study treatment in the SUMMIT study for treatment of symptomatic articular cartilage defects of the knee.

Conditions

Articular Cartilage Defects

Keywords

Cartilage legions; Symptomatic focal cartilage defects; Microfracture; MACI; Autologous chondrocyte

Outcome Measures

Primary Outcomes (1)

• Change From MACI00206 Baseline for the Participant's Knee Injury and Osteoarthritis Outcome (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.

  MACI00206 Baseline to Week 156

Secondary Outcomes (13)

• Change From MACI00206 Baseline for the Participant's KOOS Pain and Function (Sports and Recreational Activities) Scores

  MACI00206 Baseline and Week 260

• Magnetic Resonance Imaging (MRI) Assessments of Degree of Defect Fill

  Week 260

• Proportion of Patients Who Achieve at Least a 10-point Improvement From MACI00206 Baseline in KOOS Pain and Function (Sports and Recreational Activities) Scores

  Up to week 260

• The Proportion of Patients in Each Treatment Group Assessed as Treatment Failures

  Years 2 through 5 post treatment (MACI or microfracture)

• Average Time to Treatment Failure

  Up to 260 weeks

Study Arms (2)

MACI

autologous cultured chondrocytes on porcine collagen membrane implant received in previous MACI00206 study

Biological: autologous cultured chondrocytes on porcine collagen membrane

Microfracture

Microfracture treatment received in previous MACI00206 study

Procedure: Microfracture

Interventions

autologous cultured chondrocytes on porcine collagen membrane BIOLOGICAL

Implantation received in the previous MACI00206 study

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

MACI

Microfracture PROCEDURE

Arthroscopic Microfracture treatment received in the previous MACI00206 study

Microfracture

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Randomized and received study treatment (MACI or microfracture) in the SUMMIT study.

Randomized and received study treatment (MACI or microfracture) in the SUMMIT study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vericel Corporation: lead

Study Sites (14)

Urazova nemocnice v Brne

Brno, 662 50, Czechia

Location

University Hospital Na Bulovce- Department of Orthopaedic Surgery Postgraduate Medical Institute

Prague, 180 81, Czechia

Location

Polyclinique Saint-Roch

Montpellier, 34967, France

Location

Clinique Maussins-Nollet

Paris, 75019, France

Location

Hôpital d'instruction des Armées Robert Picqué

Villenave-d'Ornon, 33882, France

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

St. Elisabeth Ziekenhuis

Tilburg, 5022 GC, Netherlands

Location

University Medical Centre of Utrecht, Department of Orthopaedics

Utrecht, 3508 GA, Netherlands

Location

St Olavs Hospital

Trondheim, 7006, Norway

Location

Orthopaedic & Traumatology of Motor Organs, Independent Public Clinic Hospital

Bydgoszcz, 85-094, Poland

Location

Regional Centre of Knee Surgery & Arthroscopy, Regional Hospital of Traumatologic Surgery

Piekary Śląskie, 41-940, Poland

Location

Lekmed Medical Center

Warszewo, 01-480, Poland

Location

Kungsbacka Närsjukhus

Kungsbacka, 434 80, Sweden

Location

University of Oxford, Nuffield Dept. of Orthopaedic Surgery

Oxford, OX3 7LD, United Kingdom

Location

MeSH Terms

Conditions

Fractures, Stress

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Limitations and Caveats

Potential problems that may be observed with elective participation in extension studies were observed in the SUMMIT Extension. Thus, the value of inferential testing that compares treatment groups without accounting for missing data is limited.

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: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 2, 2010
• Study Start: December 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 12, 2021
• Results First Posted: April 27, 2017

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

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