FFLEX study

Theme Surgical and orthopaedic innovation

Workstream Novel surgical and orthopaedic techniques and devices

Status: This project is complete

During the FFLEX study we will be looking at a new type of knee implant. We will also be looking at a purpose-designed instrument to help surgeons insert the implant. Surgeons will use the implant to treat articular cartilage defects in the knee.

Articular cartilage is the smooth cartilage that lines the ends of the bones in the knee. It lets the knee move smoothly, with low friction and wear. It is hard to treat local damage to the knee, often caused by trauma such as an accident in young adult patients. This can lead to wider damage forming in the joint.

The technology behind the implant is based on Silk Fibroin, a very strong and resilient material, that is made into a highly porous Fibroin hydrogel. The manufacturer uses technology to make this into a very smooth and tough material. This material can be used to replace damaged cartilage.

Along with the implant, researchers have designed an instrument that allows surgeons to safely and reproducibly prepare the damaged area and insert the implant. This approach has shown very promising results in testing and has now progressed to being approved for implantation in humans.

FFLEX is the name of the study that will test the safety and clinical effectiveness of the implant in surgery and follow-up patients up in the longer-term.

Recruitment completed

Recruitment for this study has now been completed.