Update of ODEP ratings for Corin products
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 provides ratings for hip femoral stems, acetabular cups and knee replacements (at a knee construct level) and early 2017 commenced the process of benchmarking shoulders.
ODEP ratings explained
An ODEP Rating consists of a NUMBER and a LETTER, and a STAR (optional).
The number (3, 5, 7, 10, 13) represents the number of years for which the product’s performance has been evidenced. The letter represents the strength of evidence (data) presented by the manufacturer:
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 than the A rating (giving less confidence in the results than A), but sufficient data to demonstrate compliance
The star has been added to the rating system following revised guidelines from NICE in February 2014, A* represents very strong evidence above A and B.
Pre-entry – Products that are registered with ODEP for which there is insufficient data to evidence the three year entry benchmark have been listed as ‘pre-entry’, showing products 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.
Ceramic on ceramic not available in US
** This rating applies to the Trinity™ system when used in combination with BIOLOX ® delta, HXLPE and UHMWPE liners.
MiniHip™ - Bone conserving THR = 7A*
MiniHip™ is a ‘door-opener’ with customers and one of the only stems on the market offering true bone conservation with secure metaphyseal fixation and anatomical restoration. More than 35,000 implantations worldwide and many scientific publications supportinthe performance of this system.
Trinity™** - Advanced bearing acetabular system
Trinity™** (non ECiMa, excluding non-CAP coated cups) = 7A*
Trinity™** Cup with ECiMa liner = 5A*
Our flagship product, with over 115,000 implantations worldwide, has now secured its place in the market as one of the best cementless cups available. Our existing customers can continue to implant with confidence a cup that continues to show outstanding results.
MetaFix™ - Cementless THR
MetaFix™ collarless = 7A*
MetaFix™ collared = Pre-entry A*
Based on one of the world’s biggest selling uncemented hip philosophies, MetaFix™ now has over 47,500 implantations worldwide, The MetaFix™ stem offers our customers a reliable stem philosophy.
TriFit TS™ - Cementless Tapered Femoral Stem = 3A*
The last Corin THR launched in the market with more than 21,000 implantations worldwide. The Optimal geometry defined by global CT data for a patient matched solution.
TaperFit™ - Cemented THR = 10A
With up to 20 years follow-up and over 32,000 implantations worldwide, TaperFit™ is one of the market leaders in cemented stems.