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Methodology for Shoulders

Background

It was in 2015 that members of BESS (British Shoulder and Elbow Society) decided that they would like to develop ODEP for 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 2017.

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 replacement is a major operation which involves replacing the native shoulder joint, either by a standard “anatomic” implant replacing the head, if indicated combined with a device replacing the glenoid, or a reversed arthroplasty, where the head of the humerus is replaced by a humeral “socket” and the glenoid part consist of a “ball”, the “glenosphere. In most standard anatomic humeral prosthesis the head of the humerus is excised and a stem passed down the inside of the proximal humerus on to which a head, or a socket, in case of a reversed arthroplasty, is attached via a taper / trunnion system. In a resurfacing procedure the humeral head is left in situ and it is resurfaced. Fixation of all these implants is either by using a bone cement (“Cemented”) or by their bone facing surface attracting and becoming incorporated in the local host bone (“Uncemented”).

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.

Shoulder ratings

ODEP’s evolving Shoulder policy of rating stems, cups, reversed implants resurfacing implants and trauma implants separately is for several reasons:

Historical
1. Some manufacturers, albeit a small number, only manufacture either cups or stems
2. As many anatomic stems are also in use as hemiarthroplasty, separate rating for stem and glenoid in the anatomic prosthesis is logical (H) and (G)
3. As some manufacturers produce stems with a design or coating specially for the treatment of proximal humeral factures, separate rating for trauma implants is required (T)
4. Resurfacing (S) implants have definitely different aspects of fixation
4. For reversed shoulder prosthesis, (R) the relation between humeral socket and glenosphere is essential for the outcome, so they are rated as one construct
5. Separate submissions are required for cemented, uncemented and hybrid options

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

Shoulders stems will be considered as a separate group:
• When implants are marketed as being “Short stem”
• When Implants are marketed as “Long Stem”
• Stems that can be adapted from anatomic to reversed will be rated separately when used in a reversed construct.

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.

Glenoids will be considered as a separate group:
• when designed with bone defect expansions or additions

Rating Trauma stems
An ODEP rating will apply to trauma arthroplasty brand where each construct satisfies the following stipulations:
• It is to be used as a shoulder replacement in fracture cases
• 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

Trauma stems will be considered as a separate group:
• When Implants are marketed as “Long Stem”
• Stems that can be adapted from anatomic to reversed will be rated separately when used in a reversed construct.

Rating resurfacing implants
An ODEP rating will apply to resurfacing brand where each construct satisfies the following stipulations:
• It is to be used as a resurfacing shoulder replacement
• The material composition is identical across the range
• The implant surface finish is identical across the range
• The bone facing surface finish/coating 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

Rating Reversed arthroplasty constructs (humeral socket and reversed glenoid)
An ODEP rating will apply to reversed arthroplasty brand where each construct satisfies the following stipulations:
For the stem:
• 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.
• The taper/trunnion design is identical across the range

For the humeral socket:
• The material composition is identical across the range.
(If more than one type of plastic is used then separate submissions are required).
• 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 size
• The taper/trunnion design is identical across the range
For the liner
• The material composition is identical across the range. If more than one type of plastic is used (regular, X linked and additive) then separate submissions are required.*

For the baseplate
• The material composition is identical across the range.
(If more than one type of plastic is used then separate submissions are required).
• 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 size and screw holes.
• The taper/trunnion design is identical across the range

For the Glenospheres (reversed glenoid)
• The material from which it is made is identical across the range
• The implant specifications are the same across the range
• Glenoid components with bone defect expansions or additions should be analysed separately