Clinical Trial: BioPoly® RS Partial Resurfacing Patella Registry Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: Open Label, Prospective, Consecutive Series Registry Database of BioPoly® RS Partial Resurfacing Patella Implant
Brief Summary: The data registry will increase the knowledge of outcomes for treatment of focal cartilage defects of the patella treated with the BioPoly RS Patella Implant and will allow monitoring of the clinical safety and performance of the device and surgical implantation kit
Detailed Summary:
Sponsor: BioPoly LLC
Current Primary Outcome:
- KOOS Subscores [ Time Frame: 2 year post-op ]
- Kujala Anterior Knee Pain Scale [ Time Frame: 2 year post-op ]
- Medical Outcomes Study (SF-36) for generic "quality of life" [ Time Frame: 2 years post-op ]
- Activity using Tegner Score [ Time Frame: 2 years post-op ]
- Pain using VAS Pain [ Time Frame: 2 years post-op ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Radiographic Assessment [ Time Frame: Annually through 5 years post-op ]
Original Secondary Outcome: Same as current
Information By: BioPoly LLC
Dates:
Date Received: December 8, 2016
Date Started: September 2016
Date Completion:
Last Updated: December 12, 2016
Last Verified: December 2016