Optimising how a first-in-human device for knee replacement is introduced

During knee replacement surgery, damaged sections of the knee are replaced with metal and plastic components. In unicompartmental knee replacement (also called partial knee replacement) only a portion of the knee is resurfaced.

Ascent is a new device that can be used for a partial knee replacement. It is intended to achieve better function and longevity than existing types of devices that are currently used. The implant is now ready to be tested in humans for the first time.

A first-in-human study is a type of clinical trial in which a new drug, procedure, or treatment is tested in humans for the first time. These studies take place after the new treatment has been tested in a laboratory.

Involving patients in this type of early-phase research is complicated as it involves ethical and safety risks. Evidence also shows that patients aren’t always as well-informed as they should be, before undergoing new procedures.

Project aims

The aim of this project is to inform the design and conduct of a first-in-human evaluation of the Ascent implant.

To do this, we will:

• Establish strategies for obtaining written and verbal consent from participants
• Develop an electronic/digital method for:
  • Monitoring and modifying patient selection criteria
  • Sharing learning
• Integrate patient and public involvement and engagement in the early development and introduction of the Ascent implant

What we hope to achieve

This project we will inform how the first-in-human study of the Ascent device is designed and delivered. Our aim is also to ensure that all aspects of the future Ascent Phase I study are designed to be patient focused.