Manufacturing development of an orthopaedic knee implant for total meniscus replacement incorporating a novel load-bearing hydrogel

Over 4m people annually in the UK are affected by pain and immobility caused by a deficient meniscus, costing the equivalent of 1% GNP (NHS Business Plan 2017). The problem goes beyond age-related degenerative diseases and includes accidents/sports injuries in patients of any age.

Technological challenges in developing load-bearing materials with suitable surface characteristics for such soft-tissue orthopaedic applications restrict options for treatment. In the absence of replacement devices, the standard of care for an irreparable meniscus is partial or complete removal (meniscectomy), with 2million/year such procedures world-wide (Li 2020).

In response Orthonika, an SME spin-out from Imperial College London, has developed novel, reinforced load bearing PVA-PEG hydrogel materials for use in meniscus replacement. These unique materials are incorporated into an implant fixed directly to the bone via a reliable and established method.

Hydrogels have long been thought of as highly promising materials for soft tissue replacements, potentially opening up new markets for orthopaedic implants. Their adoption has been hampered by poor mechanical properties and low fracture toughness. Laboratory tests have shown that Orthonika's PVA-PEG materials have exceptional mechanical and tribological properties that closely mimic those of natural tissue and are superior to the standard crosslinked PVA hydrogels currently in use for other applications.

Building on previous work, Orthonika must now address technical challenges in product development to demonstrate GMP manufacturability for clinical-scale production and subsequent validation in ovine studies, targeting readiness for first-in-human clinical studies post-project.

The project enables Orthonika to:

* Manufacture at clinical-scale, bridging to development for commercial manufacturing post-clinical validation and
* Validate the TMR implant in ovine studies and therefore accelerate translation to human.

This represents significant progression towards commercialisation/clinical uptake:

* New surgical options for patients (alternatives to meniscectomy/TKR)
* Enhanced healthcare capabilities (alignment with key performance indicators such as wait times and patient recovery)
* Servicing a £1bn+ global market
* Potential adaptation to target other load-bearing orthopaedic applications (cartilage, intervertebral discs).