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ODEP Methodology

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ODEP Methodology For Shoulders

Table 4 - ODEP Benchmarks for Shoulders (from February 2021)

Click here to download the criteria sheet

 

Background
It was in 2015 that members of BESS (British Shoulder and Elbow Society) decided that they would like to develop ODEP4 Shoulders. So a group of enthusiastic shoulder surgeons got together to develop the benchmarks and the submission form.

It was decided to introduce ODEP for "Reverse TSR" to start with. A "dummy run" was instituted and the first benchmarks were awarded in 2018.

After successfully introducing ODEP for Reverse TSR, glenoid implants, Anatomic and TSR for trauma followed. They were all introduced after a successful "Dummy Run".

Shoulder ratings
ODEP’s evolving Shoulder policy of rating stems and cups separately except for “reversed” total shoulder replacement is for several reasons:
1.     Historical 
2.     Some manufacturers, albeit a small number, only manufacture either cups or stems
3.     For reversed shoulder prosthesis, the relation between head and glenoid is essential for the outcome, so they should be rated as one construct
4.     As many anatomic stems are also in use as hemiarthroplasty, separate rating for stem and glenoid in the anatomic prosthesis is logical
5.     ODEP shoulders do rate hemiarthroplasty whereas ODEP for Hips do not

Rating Stems – An ODEP shoulders rating will apply to a stem brand where each stem satisfies the following stipulations:
  It is used as an anatomic shoulder replacement or as a hemiarthroplasty
•  The material composition is identical across the range  
•  The implant surface finish is identical across the range
•  The taper/trunnion design is identical across the range
•  Implant specifications are identical across the range, other than to accommodate increases in size of the manufacturer’s “Standard” stem width and offset
•  Implants marketed as being  “Short stem” implants will be considered as a separate group
•  Implants being marketed as “Long Stem” will be considered as a separate group 
•  Stems for reversed prosthesis will be rated separately
•  Stems that can be adapted from anatomic to reversed will be rated the same, as stem fixation does not change

Rating Glenoids – An ODEP rating will apply to a glenoid brand where each glenoid satisfies the following stipulations:
•  It is used as a primary shoulder arthroplasty
•  The material from which it is made is identical across the range
•  The bone facing surface finish/coating is identical across the range
•  The implant specifications are the same across the range (including modular liner locking mechanism), other than to accommodate incremental increases in cup size and screw holes.
•  Glenoid components with bone defect expansions or additions will be analysed separately to hemispherical shells

Rating Glenospheres (reversed glenoid)
•  It is used as primary reversed shoulder arthroplasty
•  The material from which it is made is identical across the range
•  The bone facing surface finish/coating is identical across the range
•  The implant specifications are the same across the range (including modular liner locking mechanism), other than to accommodate incremental increases in cup size and screw holes.
•  Glenoid components with bone defect expansions or additions should be analysed separately to hemispherical shells

Evolution
Benchmarking TSRs produces different challenges from TKRs and THRs. One of the biggest challenges is appraising a shoulder replacement with poor functional results, but where a revision has not taken place.  In 2021, it was therefore decided to use the * ratings to include PROMS data. This seemed to be a very attractive idea, but the panel accept that the NJR PROMS data is still very limited. Another challenge is that only a few registries (the NJR and the registries in Australia, New Zealand, Finland, being the exceptions) generate shoulder data. NJR shoulder data goes back to 2012, but year on year since, has increased in volume.

As time has gone by the system has developed and taken on much of the format used by hips and knees.  As with Hips and Knees the panel is concerned about "camouflage", particularly with respect to the glenoid and the various augments currently on the market. A decision as to how this will be handled will be made later in 2021.

ODEP 4 Shoulders works closely with NJR and BESS. The final NJR classification of shoulder implants, the NJR Minimum Data Set (MDS) and the NJR Implant Scrutiny Committee take note of ODEP 4 Shoulders suggestions and concerns.


 

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ODEP Shoulders submissions review, April 2017

 

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