Post Marketing Trial Results of Total Hip Replacement Using MP-1™

The need for a more durable, metal free, non-osteolytic particle generating material in Total Hip Replacement (THR) is urgently required to reduce revision surgeries. Current used materials; Ceramic, metal and UHMWPE remain discrepant for long-term use. Polyimide (MP-1™) is a high performance biopolymer, originating from aerospace industry. MP-1™ exhibits a self-lubrication property required for bearings and articulating joints. Being resistant to fatigue, creep and chemicals and sterilisable by autoclave or irradiation, MP-1™ is ideal for medical devices.

Finalizing pre-clinical testing, two patients were implanted 12 years ago after informed consent. The Ethical Committee approved 100 patients in a single surgeon (PJB) post-marketing trial running Delta ceramic femoral ball against MP-1™ liner. Age range is from 81 to 43 years. The younger patients now being offered MP-1™, in view of the retrieval data.

Out of the 74 enrolled patients, 44 patients have the implant for more than 5 years. The only “Complications” in a few patients was an initial squeak which spontaneously disappears by 10 days and never returns. There have been no dislocations or restrictions on activity level. Oxford and Harris Hip scores along with radiology, blood and clinical examination showed remarkable results during follow-up.

MP-1™ biomaterial is used for other medical devices as well such as dental implants and trauma nails and screws.