|Registration Date||3 Jul 2018|
|Revision Date||3 Jul 2018|
Medicine Prosthesis and OrthopedyImplant
Titanium dioxideTiO2 Nanoparticle /Nanopowder CAS Number : 13463-67-7
Decreased time to healing and improved bone-to-implant stabilty Increased degree of osseointegration, created by its micro- and nano-sized structures that takes osseointegration to the next level Significantly increased strength of the bone-to-implant interface (proven in several studies) Increased range of motion Eliminates pressure, sores and pain caused by the socket Stable attachment Easy attachment and detachment Better walking ability Improved osseoperception (sensory feedback) Can be worn all day, every day Improved sitting comfort No socket adjustments required Suitable for short amputation stumps Decreased time to healing and improved bone-to-implant stabilty Increased degree of osseointegration, created by its micro- and nano-sized structures that takes osseointegration to the next level Significantly increased strength of the bone-to-implant interface
The Integrum OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System is an innovative method that significantly improves the quality of life for individuals with amputations. The system has been used by hundreds of amputees since the world's first surgery in 1990 and has been proven in several clinical studies. The OPRA Implant System is unique and available for both upper and lower limbs.
The OPRA Implant System is a bone anchored system based on osseointegration where the prostheses are directly attached to the bone and thus avoiding the use of socket. The system utilizes a modular design consisting of three main parts that have been developed and refined over the years based on many years of development and clinical research. The unique design ensures protection of the patient by avoiding bone fractures from accidental loads.
The components are coated with a new surface technology, BioHelix™, that has been developed by Integrum after 10 years of research and clinical testing. The new surface will take osseointegration to the next level and promote faster, stronger attachment to the bone, thereby increasing the strength of the bone-to-implant interface. The prosthesis is connected to the OPRA Implant System using a connection and load controlling device. Integrum has developed specific components each customized for different indications levels, including both upper and lower limb.
The OPRA components are implanted during two surgeries (read more about the Surgical procedure). The first surgery with the OPRA Implant System was performed in 1990 by Dr. Rickard Brånemark and since the start over 25 years ago, over 400 surgeries have been performed in twelve countries. Clinical studies show that the surgery significantly improves the quality of life for amputees.
A new surface technology has been introduced (BioHelix™), after 10 years of research and clinical testing. The new surface will take osseointegration to the next level and promote faster, stronger attachment to bone, thereby increasing the strength of the bone-toimplant interface.
It started already in 2006 when Integrum´s unique BioHelix™ surface was developed in close collaboration with the Department of Biomaterials at the University of Gothenburg. Since then, several experimental studies have shown more rapid healing and stronger osseointegration.