Methodology for Spine C-Disc
Introduction
With the success of ODEP for total joint replacements and about some spinal implants BASS, the British Association for surgery of the Spine approached ODEP and BC in 2018 to explore the possibilities of developing similar systems for spinal implants.
It was agreed that the basic philosophy behind ODEP, that manufacturers should collect data to support the use of their implants, should again be the driving force behind the initiative.
Likewise for Beyond Compliance the same demands apply and the same scheme should be developed with assessment, monitoring, reviews and user group meetings forming the basis of the service.
ODEP for Spine should increase patient safety and support good implants. It will be challenging to bring it to fruition.
The Challenges
Generally ODEP assesses manufacturers data against benchmarks. Most often the benchmarks are based on revision rates. For most spinal implants, even if they have failed or not achieved the desired result, they are left in situ and therefore “revision” is not a metric than can be reliably used.
PROMS will definitely be needed.
We are in the process of working out benchmarks. Unlike hips and knees, where there are numerous registries laden with data, data sources are limited.
Subdivisions of Implants
Spinal implants naturally fall into fixed and mobile. Pedicle screws, rods and cages would fall into the fixed category and disc replacements into the mobile category. They will be addressed differently.
Registry data
BSR and Spine Tango are part of the development process. BSR is run by Amplitude and Spine Tango by NEC Software Solutions.
The compliance rate in BSR is steadily increasing which is very encouraging. It took a long time before NJR achieved >90% compliance and completeness. For manufacturers to obtain ODEP ratings they will have to get data from BSR and Tango. This will almost certainly be a driver for improved utilization of the registry.
There is little doubt that when the time comes when manufacturers seek data from the registries, the compliance will improve.
Involvement with ABHI and the manufacturers of spinal implants
The ODEP spine group have kept ABHI and the ABHI spine group involved at all the stages so far. Co-operation with industry is a hall mark of ODEP. Industry are in favour of developing ODEP for Spines.
Milestones
Initial meetings late 2018
Presentations and discussion at the annual BASS meeting April 2019 (Keith Tucker guest speaker)
Meeting of interested parties supported by SCCL September 2019
Presentation to the Annual British Scoliosis association meeting November 2019 (Richard Parkinson Guest speaker)
January 2020 Inaugural meeting of the Spine ODEP
Summer 2022 First ODEP Spine Submissions Review meeting, issue of the first Spine benchmarks.
Support
Much of the impetus for ODEP and BC for Spine followed the GIRFT report on spines edited by Mike Hutton.
Prof Tim Briggs FRCS CBE is fully supportive of this initiative but it must be emphasised that ODEP is completely independent of GIRFT in its assessments. ODEP never gets involved with the cost of implants save for the fact that reduction in revision and further operations certainly reduce cost.
The BOA supports the introduction of ODEP and BC for Spine.
