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Follow-Up Study Evaluating The Long Term Safety and Efficacy of BST-CarGel and Microfracture Repair of the Knee

NCT01246895 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2018-01-24

Study results available
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Summary

This follow-up study will evaluate the effects of BST-CarGel® application to a microfractured lesion (investigational) and microfracture alone (control) for up to 5 years from treatment in subjects, treated under Protocols CG-CIP01-P and CG-CIP02-P, and will serve as a post approval study for these Protocols, in support of a commercial application. The lesions treated under Protocols CG-CIP01-P and CG-CIP02-P were focal lesions of articular cartilage, grade 3 or 4 (either ICRS or Outerbridge classification) on the medial and lateral femoral condyles of the knee, and were classified as either acute or chronic.

Conditions

  • Knee Injuries

Interventions

DEVICE

Microfracture with BST-CarGel

DEVICE

Microfracture without BST-CarGel

Sponsors & Collaborators

  • Piramal Healthcare Canada Ltd

    lead INDUSTRY

Principal Investigators

  • William Stanish, M.D · Orthopaedic and Sport Medicine - Dalhousie University

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-02-28
Completion
2014-03-31

Countries

  • Canada
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01246895 on ClinicalTrials.gov