Mapping existing hip and knee replacement registries in Europe.

Area of Science:

• Medical device surveillance
• Orthopedic surgery outcomes
• Health technology assessment

Background:

• Significant evidence gaps exist regarding medical device benefits and harms, as highlighted by issues with hip implants and breast implants.
• New European medical device regulations mandate post-marketing surveillance, increasing the need for robust real-world data.
• Registry data are proven valuable for assessing medical device real-world clinical performance and safety but are often underutilized.

Purpose of the Study:

• To inform stakeholders about the scope and content of data within European joint replacement registries.
• To highlight the potential of registries for post-marketing surveillance and research.
• To encourage greater use of registry data by researchers and policymakers.

Main Methods:

• A review was conducted to identify and analyze European joint replacement registries.
• Data on the number of registries, their coverage, and the volume of recorded joint replacement procedures were collected.
• The current focus and evolving endeavors of these registries were examined.

Main Results:

• Twenty-four European joint replacement registries were identified, predominantly with national coverage.
• These registries collectively hold over 3.1 million records for primary total hip replacements and 2.5 million for primary total knee replacements.
• Registries primarily focus on lifelong implant surveillance, surgical care quality, and hospital performance, with increasing use in benchmarking.

Conclusions:

• European joint replacement registries are a rich source of real-world data for medical device surveillance.
• Enhanced awareness and utilization of these registries are essential for improving the safety and efficacy of orthopedic implants.
• These registries play a vital role in quality assessment, regulatory compliance, and advancing orthopedic research.