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OpenTrials
Completed

NCT Number: NCT00158613

Study of the Treatment of Articular Repair (STAR)

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.

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Key information

Conditions

Articular Cartilage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Royal Columbian Hospital, New Westminster, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carticel (autologous cultured chondrocyte) implantation

Biological

Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap

Primary outcomes

  1. Mean change from baseline in the KOOS

    Time frame: Baseline, 6 month, 12 months, 24 months, 36 months, 48 months

Secondary outcomes

  1. Change from Baseline in the Modified Cincinnati Score

    Time frame: 6mo, 12mo, 18mo, 24mo, 30mo, 36mo, 42mo, 48mo

  2. 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

  3. Change from Baseline in the SF-36 Health Status Survey

    Time frame: 12mo, 24mo, 36mo, 48mo

Sponsors and collaborators

Lead sponsor

Vericel Corporation

Industry

Registry information

Official study title

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.

Important dates

Study start
2000
Primary completion
2005
Study completion
2005
First posted
Sep 12, 2005
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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