CompletedNot Applicable

the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Ankle

South Korea60 participantsStarted 2014-02-17

Plain-language summary

This study was designed to evaluate the efficacy and safety of a modified microfracture using collagen, and to compare them with those of a simple microfracture in patients with cartilage defects in their ankles.

Who can participate

Age range15 Years

SexALL

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Inclusion criteria

✓. Patients who were 15 years old or older
✓. Patients with cartilage defects in their ankle
✓. Patients with misalignment of their tibia and talus, unstable ligament in their ankle, or bony defects in the lesions of their ankle, and/or who had been treated for alignment
✓. Patients or their representative (for adults), or patients and their parent/guardian (for minors), who agreed to participate in the study and signed the informed consent form

Exclusion criteria

✕. If patients or their families suffer from or have ever suffered from an autoimmune disease.
✕. Patients who have ever suffered an anaphylactic reaction.
✕. Patients who have ever suffered hypersensitivity to an implant.
✕. Patients with a history of allergy to porcine or bovine protein.
✕. Subjects with inflammatory arthritis, such as rheumatoid and gouty arthritis.
✕. Subjects with autoimmune disease related arthritis.
✕. Subjects who are pregnant and/or breast-feeding and/or plan a pregnancy.
✕. Subjects with tumors.

What they're measuring

100mmVAS(visual analogue scale) score

Timeframe: 12 months after the surgery

Trial details

NCT IDNCT02519881

SponsorCellontech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-01-23

View on ClinicalTrials.gov More Defect of Articular Cartilage trials