We are pleased to announce that Unity Knee has achieved a 5A ODEP rating for the combination of cemented CR variant and domed patella. Existing ODEP ratings for Unity Knee are:
- Unity Knee PS, cemented, offset patella = 3A*
- Unity Knee CR, cemented, no patella = 3A
Unity Knee’s design, with over 30,000 global implantations, offers stability and satisfaction1 through medial joint line preservation and respect for soft tissues. If you would like to know more about Unity Knee and its successful clinical data, please visit the evidence base on Solutions page.
What is ODEP?
ODEP is the Orthopaedic Data Evaluation Panel. It 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 SCCL - the Supply Chain Coordination Limited) 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.
Since then ODEP has developed benchmarks for knee replacements (2014) and shoulder replacements (2017).
ODEP continues to evolve.
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.
Pre-entry 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.
References:
- Van Onsem S, The objective substrates of patient satisfaction after total knee arthroplasty, Ghent University, 2018
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