- Osseointegration Group of Australia
- Integrum (Sweden)
- Orthodynamics GmbH
- Stanmore Implants (United Kingdom)
- University of Groningen (Netherlands)
- DJO Surgical (United States)
- Dr Ronald HIllock (Las Vegas, Nevada)
Osseointegration Group of Australia – OGAP Team
Osseointegration International PTY, LTD Incorporating
the Osseointegration Group of Australia
(OPL – Osseointegration Prosthetic Limb)
*As of November 2015 the Sydney team began formalities to seek an Fda application to begin an IDE – Investigative Device Exemption study. They anticipate approval in Summer of 2016.*
The OPL implant is the latest advancement in implant technology that offers the best of both worlds. By combining the proven technology of the Swedish and German OI systems; Dr Munjed Al Muderis of Sydney Australia has developed the next generation implant.
Dr Al Muderis developed an implant that utilizes the Swedish solid titanium based concept and the German press fit technique with their three dimensional bone to implant interface. He has combined the two and added an Australian flavor by applying the latest in medical technology, which is based upon the medicine of hip replacement Bio Materials.
The German Chrome Cobalt Stem has been replaced with a stem made of a solid titanium core. Resembling the same material as the Branemark system which was developed in Sweden. The Surface proximal half is comprised of fins (similar to several hip replacement stems in use today) and provides immediate stabilization and torque resistance, allowing for immediate mobilization. Furthermore the distal half is highly porous coated, providing a multi dimentional surface structure that allows for solid bony growth into the implant (bony ingrowth) and for strong Osseointegration. This provides not only long term Osseointegration but long term survivor ship as well. Similar concepts are utilized in the features of cement-less hip replacement implants of today.
The distal conical part of the stem is a highly polished surface and coated with Ceramic Titanium Niob, which has repellent properties to bacteria and prevents colonization of bacteria on the implant. This minimizes the possibility of infection at the implant skin interface.
The OGAP Team has recently developed a quick release adaptor that is compatible with the German ILP implant and is based on German testing in Lubeck. The new adaptor allows for donning and doffing of the prosthesis with a click on click off system and is a vast improvement over the previous allen key device. All Safety mechanisms are external and can be switched out by the patient without having to see either a physician or prosthetist for repair.
The Sydney OGAP Team is led by Dr Munjed Al Mudeis and is the first to develop a single stage implant surgical technique utilizing a two piece implant system for upper extremity and lower extremity applications. With the addition of a weightless treadmill that was developed in the US by NASA. They offer an accelerated rehabilitation protocol that as most patients mobilizing ten days post op.
Integrum (Sweden) – Formerly Branemark
OPRA- Osseointegrated Prostheses for the Rehabilitation of Amputees
*In July of 2015 Integrum received a HDE – Humanitarian Device Exemption. Which gave them limited approval to conduct a study utilizing their screw fixation implant in the United States.*
“The OPRA Implant System consists of an anchoring element (the Fixture) and a skin penetrating connection (the Abutment), which is surgically inserted into the bone of the amputation stump in 2 separate surgical sessions. The patient’s prosthesis is then attached to the outer part of the Abutment through a connection device.” Excerpt taken from the website
“Osseointegrated Prostheses for the Rehabilitation of Amputees, the OPRA method, enhance quality of life and offer a greater degree of freedom in everyday life.” Excerpt taken from the website
“Integrum’s implant system OPRA (Osseointegrated Prosthesis for the Rehabilitation of Amputees) for the direct bone anchorage of amputation prostheses is based on the principle of osseointegration, which has been developed by Professor Per-Ingvar Brånemark in Gothenburg. Osseointegration implies direct contact between a titanium implant and living bone tissue. The method has been in clinical use for prosthetic replacement of teeth since 1965, and more than 200 patients have been treated.” Excerpt taken from the website
Rickard Brånemark MD PhD talks about implant surgery with bone anchored prosthesis at Sahlgrenska University Hospital in Gothenburg Sweden.
“A titanium screw-shaped implant – fixture – is carefully placed in the bone and – amazingly enough – the genetic code that commonly makes bone reject a foreign material is not activated. Instead nature follows bone cells to attach to the titanium surface and the result is a firm and permanent anchorage for a prosthetic reconstruction.” Excerpt taken from the website
Additional links regarding the OPRA Implant
(Germany – United Kingdon – Australia)
Integral Leg Prosthesis or ILP / formerly ESKA
*In 2015 AQ Implants acquired Orthodynamics. AQ is now manufacturing the Australian OPL implant and limited ILP devices. *
“The ILP is a new type of prosthetic care for above-the-knee amputees making a convetional prosthesis shaft unnecessary. The ILP is modelled on the anatomy of the human body and takes the load back to the thigh bone and hip joint when walking.” Excerpts taken from website
“The manufactuers – Orthodynamics GmbH, have many years of experience in the field of internal prosthetics and the use of state-of-the-art materials which makes this type of care possible. The ILP is implanted directly into the thigh bone facilitating a safe connection between the patient and the prosthesis.” Excerpts taken from website
“The endo-exo ESKA prosthesis is a new type of prosthetic care for above-knee-amputee patients, so that a conventional prosthesis shaft becomes redundant. Based on the anatomy of the human body, the endo-exo prosthesis transfers the load directly back on the thigh bone and the hip joint when walking.” Excerpt taken from the website
“This study aimed to assess two percutaneous trans-femoral implants, the OPRA system (Integrum AB, Göteborg, Sweden), and the ISP Endo/Exo prosthesis (ESKA Implants AG, Lübeck, Germany) on bone failure and stem–bone interface mechanics both early post-operative (before bony ingrowth) and after full bone ingrowth.” Excerpt taken from the web article
Stanmore Implants (United Kingdom)
ITAP Intraosseous Transcutaneous Amputation Prostheses
*According to Indraj Bamrah at Stanmore Implants, the ITAP version of OI is not yet commercially available and is still in the research & trial phase.*[/p]
“Based on the osseointegration concept we have developed intraosseous transcutaneous amputation prostheses (ITAP) which attempt to overcome the problems associated with infection by integrating dermal and epidermal tissues with the implant creating a soft tissue seal around the implant.” Excerpt taken from website
“Intraosseous transcutaneous amputation prosthesis is designed to achieve osseocutaneous integration. Osseocutaneous integration differs from osseointegration because the aim is to create a stable interface among the implant, the bone, and the soft tissues. This reduces the risk of soft tissue infection and troublesome discharge, which are problems encountered with current osseointegrated implants.” Excerpt taken from the website.
Additional ITAP Links
University of Groningen (Netherlands)
Direct Fixation Implant – DFI
“An alternative for prosthesis fixation using a socket is direct prosthesis fixation to the femur bone. A strong connection between the femur bone and the prosthesis fixation system is realized by using a process called osseointegration. Osseointegration is defined as the structural and functional connection between living bone and the surface of a load carrying implant. A fixture is osseointegrated if there is no progressive relative motion between the fixture and the surrounding bone and marrow under functional levels and types of loading . At the moment two osseointegrated trans-femoral prosthetic limb fixation devices are being used.” Excerpt taken from the Thesis
“The results show that the new design provides close to physiological distribution of stresses in the bone and lower bone failure risk for the normal walking as compared to the OPRA and the ISP implants. The bone remodeling simulations did not reveal any overall bone loss around the new design, as opposed to the OPRA and the ISP implants, which induce considerable bone loss in the distal end of the femur. This positive outcome shows that the presented concept has a potential to considerably improve safety of the rehabilitation with the direct fixation implants.” Excerpt taken from website
Additional Direct Fixation Implant Links
DJO Surgical (United States)
Percutaneious Osseointegrated Prosthesis -POP
*The Utah team received fda approval to conduct a study on ten Veterans with a two year follow up in July of 2015.*
“An alternative to traditional socket technology, POP involves an implant in the femur that protrudes through the skin and attaches to a prosthetic limb. Prior POP development efforts have encountered difficulty with infection at the site where the implant protrudes through the skin. Based at the University of Utah, Dr. Roy Bloebaum, PHD and his team of researchers have developed a device using DJO Surgical’s new proprietary titanium P2 (P-squared) porous coating. P2 acts as both the bone in-growth as well as the seal material on the implant that provides a “soft tissue seal” around the device to prevent bacteria from entering the body. Backed by an animal study involving over 80 sheep implanted with this device, no infections were found after one year and the implant showed excellent mechanical strength. Development work on the human implant has already started and clinical trials are expected to begin in approximately two years. The initial trial sites are expected to be within the VA system and most of the patients are expected to be war veteran amputees. The Department of Defense is eager to see rapid advancements in amputee care and have provided grant money to this end.” Excerpt taken from Web Article
Dr Ronald HIllock Las Vegas, Nevada
*Dr Hillock has conducted two Osseointegration procedure to date, under Fda custom device guidelines; although his work is NOT a part of any Fda aproved study. *