NJR Implant Scrutiny Committee (ISC)
Chair’s report – Mr Peter Howard
The ISC meets formally four times a year. The committee is comprised of surgeons, the NJR Medical Director (Deputy Chairman), and representatives from the NJR’s core contractors: University of Bristol (our Lot 2 providers), Northgate Public Services – known as NEC from July 2021 (our Lot 1 providers), MHRA, representative NJR Management Team members and ODEP/Beyond Compliance.
Examining the Data
The registry data is refreshed and analysed every six months. The committee assesses potential outlier implant performance and notifies the MHRA when there are concerns. In addition, the committee also responds to any queries and concerns raised by surgeons and regulators, undertaking additional analysis to investigate these where necessary.
We currently use a Patient Time Incidence Rate (PTIR) method to identify poor performance, in line with other registries. It has become apparent that this method alone is not sensitive to identify failure in sub-groups or in the longer term. A working group is currently developing a methodology to use Kaplan-Meier estimates alongside PTIR to improve the sensitivity of implant performance monitoring.
In addition, further stratification has also been introduced into the current analysis to separate out different sub-groups. For the coming year, primary knee replacements will be analysed by posterior stabilizing and cruciate retaining types, as it becomes clear this could make a difference to implant performance.
A working group is currently developing the processes and methodology to enable us to monitor the performance of shoulder implants more closely, in line with the current processes for hip and knee implants. This key development will ensure that the NJR is committed to even greater levels of scrutiny of implant performance.
Implants and combinations identified as outliers
Details of implants and combinations identified as outliers are again included in this year’s report. We encourage all surgeons to review this carefully to help inform their clinical decisions. Since the 2020 report, there have been several new notifications to the MHRA in hip and knee replacement. During the coming year, surgeons will be able to access a greater level of information on implant performance via our new NJR Connect – Data Services portal. In the future, we will be informing any surgeon who may be using implants identified as outliers, as soon as this status comes to light, to enable them to consider their future usage.
Peter Howard – 2021