The Royal Orthopaedic Hospital, Birmingham, England, has provided an update on the ongoing clinical study it is conducting on Intraosseous Transcutaneous Amputation Prosthesis (ITAP).
The ITAP procedure, based on the osseointegration (OI) concept, was developed by researchers at the University College London (UCL), England. The single-stage procedure involves the anchoring of a metal rod, to which a prosthesis will be attached, into the bone of the residual limb. ITAP differs from OI in that it attempts to overcome the problems associated with infection by relying on soft-tissue attachment to prevent infection, according to Gordon Blunn, PhD, head of the UCL Centre for Bio-Medical Engineering and a lead researcher on the ITAP procedure.
In the early part of the clinical study, run by Rob Grimer, MB BS, DSc, FRCS, FRCSEd(Orth), consultant orthopedic oncologist from the Royal Orthopaedic Hospital, some of the study patients suffered low-grade infections, so the ITAP implant was adapted to include use of a silver coating that is intended to reduce infection risk. “The bone and skin grow onto the implant, which works like a tooth implant,” Grimer said. “We hope that the implant design and the use of silver will help reduce the infection risk so that the trial can be successfully completed.”
The clinical study involves a small number of patients; it is being sponsored by Stanmore Implants, Hertfordshire, England, the medical device manufacturer that makes the investigational device.