Study of the Treatment of Articular Repair (STAR)

May 10, 2021 updated by: Vericel Corporation

A Prospective, Longitudinal Within-Patient Evaluation of the Effectiveness (Durability) of Carticel® (Autologous Cultured Chondrocytes) Compared to Non-Carticel Surgical Treatment for Articular Cartilage Defects of the Knee.

This study is a prospective, longitudinal, multi-center, within patient evaluation of patients with articular cartilage defects of the knee who have had an inadequate response to a prior non-Carticel surgical treatment. Patients who met eligibility criteria were enrolled in the study. Subsequent to implantation with Carticel patients have follow-up every 6-months up to 48-months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 4

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

  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W7
        • Royal Columbian Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
    • Ontario
      • London, Ontario, Canada, N6A 3K7
        • Fowler Kennedy Sports Medicine Clinic
  • United States
    • California
      • Los Angeles, California, United States, 90045
        • Kerlan Jobe Orthopaedic Clinic
      • San Diego, California, United States, 92134
        • Naval Medical Center San Diego
      • Santa Monica, California, United States, 90404
        • Santa Monica Orthopedic Group
      • Sonoma, California, United States, 95476
        • Office of Dr. Noah Weiss
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Denver/Vail Orthopedics
    • Connecticut
      • Farmington, Connecticut, United States, 06034
        • University of Connecticut Health Center
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Atlanta Sports Medicine & Orthopaedic Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Midwest Orthopedics
      • Peoria, Illinois, United States, 61602
        • Midwest Orthopaedic Center
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Orthopaedics Indianapolis
    • Iowa
      • Cedar Rapids, Iowa, United States, 52401
        • Physician'S Clinic of Iowa
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Bluegrass Orthopaedics
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • National Naval Medical Center
      • Clinton, Maryland, United States, 20735
        • Washington Orthopedic & Knee Clinic
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital
      • Brookline, Massachusetts, United States, 02445
        • Pro Sports Orthopedics
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota
    • New York
      • Rochester, New York, United States, 14642
        • Strong Memorial Hospital, University of Rochester
      • West Point, New York, United States, 10996
        • Keller Army Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center
    • Texas
      • Beaumont, Texas, United States, 77707
        • Beaumont Bone and Joint
      • Houston, Texas, United States, 78234
        • Brooke Army Medical Center, Fort Sam
    • Virginia
      • Portsmouth, Virginia, United States, 23708
        • Naval Medical Center Portsmouth
      • Richmond, Virginia, United States, 23294
        • Advanced Orthopedic Center
    • Washington
      • Spokane, Washington, United States, 99204
        • Northwest Orthopedic Specialists

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provided written informed consent
  • Documented history of at least one Grade III or Grade IV defect (modified Outerbridge classification) on the medial or lateral femoral condyle or trochlea
  • Failed prior treatment for articular cartilage defects of the knee, e.g. inadequate response to a non- ACI surgical procedure to treat the lesion, within past 3 yrs
  • Patient reported overall knee condition of 5 or less on the Modified Cinn Rating System
  • patients must have had a cartilage defect located on the medial or lateral femoral condyle or trochlea which had an inadequate response to a prior arthroscopic or other non-Carticel surgical repair procedure

Exclusion Criteria:

  • see above

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in the KOOS
Time Frame: Baseline, 6 month, 12 months, 24 months, 36 months, 48 months
Baseline, 6 month, 12 months, 24 months, 36 months, 48 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in the Modified Cincinnati Score
Time Frame: 6mo, 12mo, 18mo, 24mo, 30mo, 36mo, 42mo, 48mo
6mo, 12mo, 18mo, 24mo, 30mo, 36mo, 42mo, 48mo
Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport
Time Frame: 12mo, 24mo, 36mo, 48mo
12mo, 24mo, 36mo, 48mo
Change from Baseline in the SF-36 Health Status Survey
Time Frame: 12mo, 24mo, 36mo, 48mo
12mo, 24mo, 36mo, 48mo

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

March 1, 2000

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • CARTCEL 012-99

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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