CompletedNot Applicable

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

Canada67 participantsStarted 2011-03

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The subject was treated under Protocol CG-CIP01 or CG-CIP02 and completed 12 month follow-up period * The subject has understood and signed a Research Ethics Board(REB) approved Informed Consent Form (ICF) Exclusion Criteria: * The subject was not treated under Protocol CG-CIP01-P or CG-CIP02-P * The subject did not complete 12 month follow-up period

What they're measuring

Degree of Lesion Filling (%Fill) by Repair Tissue at Degree of Lesion Filling (%Fill) by Repair Tissue at 5 Years Through MRI.

Timeframe: 5 years

Repair Tissue Quality (T2 MRI)

Timeframe: 5 years

Trial details

NCT IDNCT01246895

SponsorPiramal Healthcare Canada Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-02

Results submitted2016-01-07

View on ClinicalTrials.gov More Knee Injuries trials