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ODEP explained


FAQ

1.     What is ODEP?

2.     How do ODEP ratings work?

3.     What products are ODEP rated?

4.     Why are ODEP ratings important?

5.     Discussing ODEP ratings with your surgeon



 

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 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.


ODEP provides the NHS with an approved list of prostheses that meet the revision rate standard at 10 years set out in NICE guidance and which are suitable for use in primary hip and knee replacement. The two components of hip replacement prostheses - stems and cups - receive separate ratings. A feasibility study of data submissions for Reverse Shoulder arthroplasty commenced in 2016.

How do ODEP Ratings work?

Implant manufacturers are invited to submit data regarding their orthopaedic implant products to ODEP in a defined format (an ODEP submission form). The Panel reviews this submission, and rate the strength of the evidence presented by the manufacturer, resulting in the award of an ODEP rating. Only products that demonstrate compliance with NICE guidance will be awarded a rating.

 

Whilst the NICE benchmark is set at measuring performance after ten years, products need to be tracking to achieve the ten year benchmark, but do not need to have ten years of data in order to achieve a rating.

 

An ODEP Rating consists of a NUMBER and a LETTER, and a STAR (optional)

e.g.

 

The number represents the number of years for which the product's performance has been evidenced.

10

ten years of evidence - full compliance with NICE benchmark.

7

seven years of evidence - product is on-track to achieve the 10 year benchmark, but has not yet got sufficient data to evidence performance at 10 years.

5

five years of evidence - product is on-track to achieve the 10 year benchmark, but has not yet got sufficient data to evidence performance at 10 years.

3

three years of evidence - product is on-track to achieve the 10 year benchmark, but has not yet got sufficient data to evidence performance at 10 years. 

 

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, in which a benchmark replacement rate of less than 1 in 20 (5%) at 10 years was defined. The star is awarded where products are evidenced to comply with this benchmark. A* represents very strong evidence above A and B. Ratings without a star signify compliance to the prior NICE guidance of a replacement rate of less than 1 in 10 (10%) at 10 years.

 

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.

 

 

 

Implants are expected to progress through benchmarks from pre-entry through 3, 5, 7 and 10 year benchmarks as data becomes available.  Failure to follow this progression within a defined timescale will result in removal of a products ODEP rating.


It is important to note that ODEP rates evidence (data) presented to it by the implant manufacturer.

What products are ODEP rated?

ODEP provides ratings for hip femoral stems, hip acetabular cups and total knee replacement implants (see the section on Knee Benchmarks for more detailed information). ODEP for Shoulders is at an advanced state of development, and some Shoulder devices will be fully benchmarked by 2018.

 

At present, ODEP do not provide benchmarks for unicondylar knee replacements, patella femoral knee replacements or other partial knee replacements, however, this continues to be under review.

Why are ODEP ratings important?

There are many factors that can affect the performance of an implant – the skill of the surgeons using it, the types of patients it is used with to name just two. Where an implant is revised, attributing the cause of the revision to the implant is also a complex science – particularly in hip surgery where the patient is likely to have received more than one implant.


ODEP ratings provide a simple, independently verified assessment as to the performance of an implant, assessed against national clinical best practice guidelines. This enables clinicians to ensure that the implants that they use comply with these national guidelines. This is an important factor (but certainly not the only factor) for surgeons to consider in selecting the right implants to use in any joint replacement procedure.

Discussing ODEP ratings with your surgeon

One of the things you may want to discuss with your surgeon is the type of implants they will be using in your procedure. Your surgeon is best placed to advise which implants are most suitable for use in your procedure. They will consider your age, gender, weight, lifestyle, and severity of joint degeneration as well as their own experience before making a recommendation or choice as to which implant is right for you.

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