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BiPhasic Cartilage Repair Implant (BiCRI) IDE Clinical Trial - Taiwan

NCT01477008 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2022-01-20

No results posted yet for this study

Summary

The purpose of this trial is to evaluate the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI) compared to marrow stimulation in the treatment of chondral and osteochondral lesions located on the medial femoral condyle, lateral femoral condyle, or trochlea of the knee. The hypothesis is that the BiCRI provides an improvement in pain and function as compared to baseline, that is no worse than marrow stimulation at 1 year.

Conditions

  • Chondral or Osteochondral Lesion of Medial Femoral Condyle
  • Chondral or Osteochondral Lesion of Lateral Femoral Condyle
  • Chondral or Osteochondral Lesion of Trochlea

Interventions

DEVICE

BiPhasic Cartilage Repair Implant

1 or 2 BiCRI devices, depending on lesion size

PROCEDURE

Marrow Stimulation

Microfracture or Subchondral Drilling

Sponsors & Collaborators

  • BioGend Therapeutics Co.Ltd

    lead INDUSTRY

Principal Investigators

  • Gwen Chang, MS · BioGend Therapeutics Co.Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2019-04-30
Completion
2019-08-31

Countries

  • Taiwan

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 NCT01477008 on ClinicalTrials.gov