Perfecting soft tissue attachment interface to an osseointegrated transdermal implant to deliver a predictable and robust patient outcome.

Amputees rely on sockets to attach prosthetic limbs. Problems with the stump-socket interface include pressure sores, infections, remodelling of tissues and fluctuations in stump size, which can lead to limb disuse. Patients attend numerous clinics to address these complications resulting in a significant burden to the NHS and patient. Intraosseous Transcutaneous Amputation Prosthesis (ITAP) aims to overcome these problems by attaching the artificial limb to the skeleton via a skin-penetrating implant. ITAP relies on an infection resistant skin seal. Previous work has shown that integration of the dermis and epidermis into a porous structure is important in sealing the implant interface. On-going phase one trials indicate that the current technology is highly beneficial but not as repeatable or robust as desired. The key goals of this project are to develop additive layer manufacturing (ALM) to produce mechanically-appropriate porous titanium, which integrates more securely with dermal and epidermal tissues. Porous titanium alloy structures will be tested and challenged using in vivo models. The key deliverable is the successful translation of ALM technology into human ITAP implants that provide patients with an effective and long-lasting solution for the attachment of their prosthetic limb, thus reducing the burden to the NHS.