Trials / Completed
CompletedNCT01477008
BiPhasic Cartilage Repair Implant (BiCRI) IDE Clinical Trial - Taiwan
A Prospective, Multi-Center, Randomized Clinical Trial Comparing the Biphasic Cartilage Repair Implant to Marrow Stimulation in the Treatment of Focal Chondral and Osteochondral Lesions of the Knee
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- BioGend Therapeutics Co.Ltd · Industry
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | BiPhasic Cartilage Repair Implant | 1 or 2 BiCRI devices, depending on lesion size |
| PROCEDURE | Marrow Stimulation | Microfracture or Subchondral Drilling |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2019-04-01
- Completion
- 2019-08-01
- First posted
- 2011-11-22
- Last updated
- 2022-01-20
Locations
11 sites across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT01477008. Inclusion in this directory is not an endorsement.