BioPoly™ RS Partial Resurfacing Implant
Research type
Research Study
Full title
Open label, prospective, consecutive series registry database of BioPoly™ RS Partial\nResurfacing Patella Implant
IRAS ID
185421
Contact name
Herb Schwartz
Contact email
Sponsor organisation
BioPoly, LLC
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
BioPoly RS Partial Resurfacing Patella Implant is a long-term, surgically invasive device indicated for the replacement of symptomatic focal lesions located in the facets of the patella(kneecap). The implant is considered to be a ‘partial hemiarthroplasty’ as it is used to only replace a limited diseased portion (partial) of one joint surface (hemi) and is not appropriate for the treatment of generalized degenerative or autoimmune joint disease. The aim of this prospective, nonrandomised registry study is to assess the post-operative clinical outcomes of patients treated with the implant and to make comparisons with pre-operative status.\nThe primary objective is to compare preoperative and postoperative clinical status, including knee function, overall health, pain and activity level. The primary objective will be assessed at 6 months and 2 years post-op. The 6 month endpoint\nwill provide an early indication of clinical success.\nThe secondary objective is to compare pre-operative and post-operative clinical status (knee function, overall health, activity, and pain level) of patients treated with the BioPoly RS device throughout the other time points in the study. Values will be reported and compared. Additionally, the effects that relevant covariates have on the outcome variables will be analysed. As is customary for a registry database, the data will be available for further analysis as requested by the investigators. As a safety objective, serious adverse events will be monitored continuously throughout the study. Also, radiographs that are performed as part of normal clinical follow up will be assessed.\n
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/1680
Date of REC Opinion
31 May 2016
REC opinion
Further Information Favourable Opinion