Case Study: National Joint Registry (NJR) and NICE HTG21

What Large Registries Can — and Cannot — Deliver for Emerging Technologies

The National Joint Registry (NJR) is one of the largest orthopaedic registries internationally, containing more than 3 million records since 2003. In NICE HTG21 on robot-assisted surgery for knee and hip replacement (2025), NICE described the NJR as “the most robust and relevant data source for the National Health Service.”

Despite this, NICE concluded that the available evidence remained insufficient to support a definitive recommendation for robot-assisted orthopaedic surgery. Instead, the technology was routed into the Early Value Assessment (EVA) pathway with a three-year evidence generation period.

Why the Existing Registry Data Was Insufficient

According to NICE, the NJR “did not contain enough robot-assisted surgery procedures to allow direct comparisons.”

The case highlights several limitations that can arise when existing registries are used to evaluate newer technologies:

limited numbers of robot-assisted procedures,
inability to reliably separate robotic from conventional procedures,
limited capture of learning curve effects,
and insufficient granularity for certain comparative analyses.

Importantly, these limitations do not reflect a lack of credibility of the registry itself. Rather, they illustrate that even highly established registries may not automatically contain the structure or volume of data required for newly emerging technologies.

Implications for Evidence Generation and HTA Strategy

The NJR case illustrates an important consideration for medical device manufacturers and evidence generation teams.

Participation in a large registry alone does not necessarily ensure that future HTA or reimbursement questions can be answered adequately. The suitability of registry data depends on factors such as:

coding structure,
procedure granularity,
technology adoption volume,
and the relevance of captured outcomes for the intended assessment.

For emerging technologies, these requirements may evolve faster than existing registry structures.

Conclusion

The NICE HTG21 decision demonstrates that even highly respected registries can face limitations when assessing newer technologies with limited procedural volume and evolving clinical practice.

For manufacturers, this reinforces the importance of evaluating early whether existing evidence infrastructures are capable of generating the specific evidence required for future HTA and reimbursement assessments.

If you would like to discuss registry strategy, evidence generation planning or HTA considerations for emerging medical technologies, please feel free to contact the team at athagoras Medtech directly.