ODEP methodology Explained
This section starts by explaining the ODEP methodology that is generic across all the types implant that ODEP benchmark. Separate sections are devoted to specific joints where the methodology has been adapted to embrace specific features peculiar to that implant or construct.
The Underlying Philosophy
ODEP wants to make sure manufacturers look very critically at the performance of their products. We want to acknowledge successful implants and deter the use of poor ones.
ODEP is aware of the dangers of "big data" where poor results can be obscured or camouflaged by good results because the monitoring system lacks granularity.
Thus the submission forms are designed to comprehensively assess an implant and make sure that it performs well in the hands of all those who might want to use it
The features common to all the submission forms include
• Description of the implant (Hip, Knee, Shoulder, Elbow, Spine)
• Date of this submission
• Product codes
• Date when ODEP benchmark first awarded
• Picture of the implant.
Technical design features, examples to include
• Fixation technology
• Modularity (if appropriate)
• Such as in the case of Spine, mobile / fixed
• Date of first clinical use
• Date of original CE mark
• Date of latest CE mark (since MDR)
• Date of latest UKCA mark
• Have there been any alterations to the design? (date)
• Is the data submitted representative of all studies conducted in relation to it? Have there been any reports or publications indicating inferior results to those submitted? Is the clinical data submitted for this stem representative of the results of all studies conducted in relation to it?
• Have there been any FSN (Field Safety Notices) issued for this product?
• Number of centres / Number of surgeons
• Origin of data
• Number of patients, M:F ratio, age range
• Number of revisions
• Reasons for revision
• Survival analysis
To learn about the full extent of the data that is required for a submission please go to section "Submit a product" and download the submission form for which ever joint attracts your interest
At present RSA is not a requirement for an ODEP rating but we are interested in how widely it is available. There seems to be little doubt that a satisfactory RSA study at one year post the index operation is associated with good outcomes, certainly up to 10 years.
Patient Matched Implants and other "Custom" TJRs
It is unlikely that ODEP will ever benchmark the traditional "Custom" implants. These are the implants, traditionally used in tumour work or where large parts of a patient's skeleton are removed for pathologies other than arthritis. These implants do not and will not have CE (or UKCA) marks in the future unless there is a major change in everyone's view.
With the introduction of "Patient matched" implants ODEP is prepared to accept submissions for these types of implants provided they have a CE or UKCA mark.
Several commentators have been critical of ODEP's policy to benchmark any of this range of implants saying they are all unique and there is no line of implants against a brand can be compared and therefore it is impossible to accord a benchmark. Some of the same commentators have suggested that by benchmarking this increasingly popular type of implant ODEP will be increase their marketing power; most of these implants carry a surcharge compared with the regular ones.
ODEP has made its decision based on the following facts:
• There is no other organisation that is encouraging the manufacturers of the devices to make sure data is collected and reviewed by the manufacturer and then externally validated by an independent body
• Patients should know that there is an organisation assessing the performance of these devices and making sure that the appropriate action is taken if they perform badly
• That manufacturers of these implants want to have them judged to the same standard as the standard devices in the same market.
• That except for their size or shape or design they must, otherwise be the same ie, material, surface coating /finish, fixation method etc
ODEP has decided to use the phrase Patient matched for this increasingly popular group of implants instead of any of the other options that are available. These include: Bespoke, tailor made, patient specific etc
Basis of the manufacturing process
Nowadays the design of these implants is almost always based on a CT or MRI of the joint. The details from the scan is fed into the machine that mills the joint to the dimension's of the native knee or the manufacturing is undertaken using additive surface layer technology also known as 3D printing.
Andrew Porteous (Bristol) has recommended to ODEP that the following classification is adopted which is along the lines suggested by the IMDRF:
Personalised Implant Classification (PIC)
– unique but for abnormal anatomical variation/pathology, no CE, no ODEP rating
2. Patient Matched
– within a specific design envelope, 1 implant supplied in theatre
– expected for use with normal anatomy, common pathology & in large numbers
Category 1: Best fit for patient selected from a mass/batch produced wider range
Category 2: Unique implant individually made for one patient
– Mass produced but adapted/adjusted/assembled in theatre to suit an individual patient’s anatomy/pathology e.g. revision knee systems.
One thing is for certain and that is ODEP will review this policy on a regular basis.