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