Given the recent Humanitarian approval from the FDA of the Swedish implant, I thought it would be prudent to give an update on where things are today with Osseointegration in the United States. There has also been some misinformation floating around regarding the various teams and their work; which is never a good thing when people are researching their options.
In July we saw the Swedish team under Rickard Branemark receive Humanitarian approval by the FDA for their screw fixation OPRA device. Approval of the device doesn’t mean Osseointegration is now an accepted form of treatment here in the US. It simply means Integrum was given permission to conduct trials under an FDA approved study. Approval is limited to Ak procedures and has a pretty rigid exclusion criteria for patient selection. The procedure is conducted in two stages and can take up to 12 months before a patient begins mobilizing. From what I understand the study has not yet commenced but soon we will be seeing implants being done using this device up in San Francisco under the approved guidelines.
I spoke to the Utah group recently and they were able to confirm a few facts. Their team will be utilizing an implant design made by DJO here in the US. Nothing new there but after several years of clinical studies on animals; they did receive FDA approval to begin their human trials this past July and have been busy preparing for their first round of surgeries. They are still screening prospective patients but have already selected their initial subjects. Their patient base will be made up solely of Veteran Amputees and are on track to perform the first round of surgeries by the end of 2015. The initial FDA approval is for ten subjects and they anticipate having all ten done by June of 2016. The procedure will be done in two stages; six weeks between surgeries, with immediate mobilization thereafter.
The work being done up in Utah has no affiliation with any other center; as their research is exclusive and they are utilizing a device that has been designed solely by their team after extensive animal trials. Long term, the Utah group anticipates being up and running in a commercial capacity for both military and civilian applications in three to five years.
There is also a surgeon in Las Vegas who has done a single implant procedure under what has been reported by some as an FDA study. The surgery was performed by Orthopedic Surgeon Ronald Hillock and the implant was manufactured by Signature Orthopeadics in Australia. There is some conflicting information about what kind of approval he actually has but most likely, the surgeon is performing the procedure under a FDA custom device designation; which limits the amount of procedures to five per year. As the only two teams who possess FDA approval to conduct a study here in the United States are Integrum under Branemark and the Utah group.
From what I understand the surgeon will be conducting his second surgery later this month. The procedure is done in two stages with 8 weeks between surgeries. I’m not clear what the rehabilitation protocol is, as he has only done a single surgery and it takes time; as well as a number of patients in order to develop a proper Rehabilitation protocol when dealing with Osseointegration patients.
The first Osseointegration procedure conducted in the United States was performed in Utah by a surgeon who is not affiliated with the Utah Osseointegration team I previously mentioned. A modified compress device was utilized that is manufactured by Zimmer Biomet here in the United States. Rather than taking an implanted stem approach; the device is coupled near the distal end of the bone and is held in place by a series of screws. The device was initially designed for bone tumor applications. There is not a lot of information about their work being published but from what I understand; when modified for Osseointegration applications, full load bearing is not allowed until three months post Op.
There is also a team in Pittsburgh Pennsylvania who is utilizing this same compress device and has done an unknown number of procedures to date. Their work is being conducted under limited FDA custom device guidelines and they have also been working with Walter Reed to develop an Osseointegration program ultimately seeking to use both the Compress and the Swedish OPRA devices. The two surgeons mentioned above are not interested in being contacted by the general public about Osseointegration. So I chose not to include their names.
The Osseointegration Group of Australia team under Assoc Professor Munjed Al Muderis, is currently seeking FDA approval of their OPL implant. The device is manufactured in Germany by AQ Implants; who recently acquired Orthodynamics (the previous manufacturer of the now discontinued German ILP device). They anticipate receiving approval to begin working in the United States in early 2016.
The OPL device is modeled after modern day hip stems and is offered as a single stage procedure that has patients mobilizing within a week post op; same as with hip replacement procedures being done today. To date, their implant is the most advanced design on the market; offering a single stage procedure and nearly immediate mobilization for both Ak and Bk applications. Knee, hip replacement and limb lengthening procedures with Osseointegrated implants are also being successfully performed by this team. The Sydney team has conducted 170 procedures and is scheduled to reach the 200 mark by years end. Which means they have done more procedures than any other team worldwide.
Even though we are seeing movement in the United States surrounding the use of Osseointegration technology; there remains a lot of work to do before we see it being commonly used as an option to socket based technology. The various teams not only have to finalize their various studies but perceptions surrounding the safety of the technology still needs to change. We are seeing that happen more and more but there also remains a large segment within both the Medical and Amputee communities in general, who don’t fully understand where the technology is today. Osseointegration has been around since 1990 as it relates to amputees and has come a long way since its inception. It has become a safe alternative to socket technology, with proven results and a large number of satisfied patients.
Osseointegration isn’t for everyone but if you are one of those amputees who struggle with socket technology, there is hope; as change is on the horizon. We are certainly in some very exciting times!