With over 35,000 implantations worldwide, TaperFit™ has been part of Corin’s Hip continuum of Care, providing solutions for a wide range of patient indications since 1995. A reliable, cemented solution based on a clinically proven design philosophy, TaperFit is the first femoral stem of Corin's hip portfolio to achieve an ODEP 13A rating.
What is ODEP?
ODEP (Orthopaedic Data Evaluation Panel) is an independent panel of experts comprised mainly of leading UK surgeons, but also non-clinical experts with deep experience of the orthopaedic industry. The Panel was set up by National Health Purchasing and Supply Agency (PASA, subsequently replaced by NHS Supply Chain) as a response to National Institute for Health and Care Excellence (NICE) issuing guidance relating to Total hip replacement and resurfacing arthroplasty for end-stage arthritis of the hip (http://www.nice.org.uk/Guidance/TA304) - first publication April 2000, most recent publication in February 2014.
Implant manufacturers are invited to submit data regarding their orthopaedic implant products to ODEP. The panel reviews this submission and rate the strength of the evidence presented by the manufacturer, resulting in the award of an ODEP rating.
ODEP ratings explained
An ODEP rating should simply define a products clinical performance. It fundamentally consists of a NUMBER and a LETTER (and in some cases a STAR).
The number represents the number of years for which the product’s performance has been evidenced. Categories are 3, 5, 7, 10 and 13 years.
The letter represents the strength of evidence (data) presented by the manufacturer:
A* Very strong evidence.
A Strong evidence. Generally higher numbers of patients (giving greater confidence in the results presented), with all patients being subject to follow-up (their outcomes recorded).
B Acceptable evidence. Smaller numbers of patients giving less confidence in the results, but enough data to demonstrate compliance
There are ratings for new products that are registered with ODEP for which there is insufficient data to evidence the three-year entry benchmark but are currently undergoing clinical evaluation.
Pre-entry A* Products are being evaluated through the Beyond Compliance initiative, a post market surveillance service supported by ODEP.
Pre-entry Products not under Beyond Compliance, but which are registered with the National Joint Registry.
Latest ODEP ratings can be found at www.odep.org.uk
For any further information, please contact us