Ever heard of the Freedom disc???

[KBear]

I finally figured out what clinical trial my surgeon is talking about me being in. The disc is called the Freedom Disc and is made by AxioMed. All I can find is AxioMed's website that tells about the disc and clinical trial information. The clinical trial information shows that the disc is being studied in Europe. My doctor said that the trial should start by January; but I won't be having surgery until March (I have a cruise planned in February and he said it would be best to wait until after that for surgery). I have never heard of AxioMed or the Freedom Disc and just wanted to know if any of you know anything about it?

[dbalkema]

I too am waiting for the Freedom Lumbar disc through Axiomed. I am a patient of Texas Back Institute and my Doctor is Dr. Sachs.

I was actually told about this clinical trial in September. I was told that I could have surgery as early as this past October, but trial paperwork and misscommunication between TBI and Axiomed has set it back. As of Dec. 19th.... I talked with the research department for TBI that handles clinical trials. The TBI board of directors has not approved this clinical trial yet. From what I was told, they are having issues with Axiomed and approval from the FDA for the clinical trial. I don't know the details....but I am beginning to wonder if this trial is going to take place.

According to www.axiomed.com, there are over 22 sites that will be conducting this trial. But, according to www.clinicaltrials.gov, A hospital in Germany is the only one conducting the trial as of right now.

Everyone I have talked to from TBI and the research department seems to have no clue when the trial will actually start.

I actually did call Axiomed about a month ago.... The lady I talk with told me that they were going to try to get the trial started in December....but that didn't happen.

Let me know if you have heard anything different.

Dan

[Slackwater]

Originally Posted by KBear

I have never heard of AxioMed or the Freedom Disc and just wanted to know if any of you know anything about it?

Yes, heard of it. Axiomed's Freedom Lumbar Disc (FLD on clinicaltrials.gov) study is anticipated. Axiomed has a polymer middle (core?) and titanium end plates. The polymer is viscoelastic. The titanium allows for better radiographs w/o distortion; that is good news.

The question I had earlier was what are the guidelines for polymers from the FDA(?). I am not a subject matter expert, but the real experts think it is OK with established guidelines for orthopaedic and cardiac use so there have to be previous devices.

ref: PolymerTech

PTG presented biocompatibility test data related to the polymer used in

the AxioMed lumbar device in April 2007 at the annual meeting of the Society for Biomaterials in Chicago.

The test results showed that the thermoplastic silicone-polycarbonate-urethane used in the PTG polymer met FDA and international standards for use in orthopedic implants.
Performance testing on the polymer also showed that it met appropriate specifications for strength and viscoelastic properties.

PolymerTech was acquired by a Dutch company, no worries. The Dutch company makes Dyneema used in medical implants, thinking specifically of the also SpinalKinetics the M6-C and M6-L, random data.

Assume there will be something published about the Axiomed FLD European implants shortly, possibly before you might be scheduled for an operation. I will keep my eyes open in Spine, The Spine Journal, European Spine Journal, Clinical Biomechanics, Journal of Biomechanics ..., early results may possibly be in the AAOS meeting Feb 25-28 in Las Vegas.

Assume polymers are OK+ long term based on previous FDA approvals in orthopaedic and cardiac use. Might want to look for strain testing blah blah blah. The data that I'm after is:

a) FLD IAR (Instantaneous Axis of Rotation) in testing in-vitro with preload and
b) any FEA (Finite Element Analysis) model done.

You may alienate your surgeon if you ask for that data, ... Surgeons like(?) a written list of questions vs. verbal rambling, but some questions may cross a line in the sand. My limited thinking is this may solve some of the challenges with constrained v. unconstrained devices, loss of annulus integrity ... looks like it goes in ventrally(?), possibly ventrolaterally. Anterior Longitudinal Ligamet(ALL) issue still there(?) with ventral access..., ventrolateral access saves the ALL (?). A close-up of the FDL and the supporting instruments give a clue how it goes in, as do operating instructions.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

slackwater_sf
mva, 2-level lumbar surgical candidate, cervical tbd

[Slackwater]

Originally Posted by Slackwater

The data that I'm after is:

a) FLD IAR (Instantaneous Axis of Rotation) in testing in-vitro with preload and
b) any FEA (Finite Element Analysis) model done.

Axiomed Testing Data:






Trying to answer my own questions, ... There are titanium beads; the end plates may / may not be titanium.
FLD surgical movie shows ventral access. Movie (called Animations) were found on the site map.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

slackwater_sf
mva, 2-level lumbar surgical candidate

[Terry]

This disc looks like it closely mimics the human disc. That looks promising based on the numbers. Of course this will only be seen after much research utilizing us patients as the guinea pigs.

Oh Well. This is the nature of things.

I hope that these discs only keep getting better and better. It will truly be a miracle if they can keep hardware out of us entirely as the implants leave too many places for nasty bacteria to hide and cause problems.

Terry Newton

[annapurna]

Originally Posted by Slackwater

Yes, heard of it. Axiomed's Freedom Lumbar Disc (FLD on clinicaltrials.gov) study is anticipated. Axiomed has a polymer middle (core?) and titanium end plates. The polymer is viscoelastic.

It looks like this ADR has the polymer fixed to both endplates with the viscoelastic response acting like a normal health disc rather than like the core shifting around in the normal ADRs. We've talked before on this board about the dangers of wear particles in a shifting core design ADR. This one would seemingly eliminate that but, speaking as an engineer responsible for seeing that things that are bonded together remain bonded, I'd be careful with this design. It's difficult to maintain a bond subjected to high-cycle loading (lots of flexing of your ADR) and I'd be interested in seeing how they managed it without leading to long term biocompatibility problems.

[KBear]

Ok, I am so over my head in understanding what you all are talking about. I am just kinda getting what restrained (no 'loose' polyurethane) or unrestrained means. I have no idea about the annulus... I have read that it can be left in? This makes absolutely no sense to me, I thought it was part of the disc, thus needing removed??? Slackwater- Is this information good or bad? I have been trying to research all of this stuff; but am definitely not even close to understanding the complex stuff. I get the general idea. If any of you would like to explain all this to me, I would really appreciate it. I am trying to make an informed decision; but feel like I don't even know enough to know that I don't know. I feel like I need a medical degree to figure it out. So, please help!

[KBear]

Originally Posted by Slackwater

Axiomed Testing Data:






Trying to answer my own questions, ... There are titanium beads; the end plates may / may not be titanium.
FLD surgical movie shows ventral access. Movie (called Animations) were found on the site map.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

slackwater_sf
mva, 2-level lumbar surgical candidate

Does this bottom graph mean that the disc has a high failure rate? If so, is this a high failure rate for ADRs in general? I am so lost.

[berry]

Hi Kathy

It is all so confusing and difficult to understand. Looking at the graph I read it as the disc can take high compressive loads, almost four times more than a natural disc with no failure.

There's a surgeon in Manchester, England, who uses this Freedom disc (currently on trial but expected to get the CE kitemark in March 09) but I don't know what his outcomes are like. He is also about to pilot a new disc called the Embody by Nuvasive, it is all polyethylene. Woven sheets of polyethylene folded together, a bit like a concertina I believe which is quite hard. To ensure its positioning in the spine a screw is inserted into a loop on the implant. (There's scarce information available as yet but we've discussed this a little on the UK site here
http://z6.invisionfree.com/adrsuppor...?showtopic=900 )

I don't know if Mr Ross would share information but if you'd like to contact him the details are:

Mr Raymond Ross, Consultant Spinal Surgeon

Phone number: 0161 206 1199 Email: raymond.ross@srft.nhs.uk Special interests/ expertise: I deal only with spinal problems including cervical spinal problems.

Salford Royal NHS Foundation Trust (Formerly Hope Hospital)
Stott Lane,
Salford
Manchester
England
M6 8HD

Let us know what you find.

Best wishes

Lynda

[JasonR]

Originally Posted by KBear

Does this bottom graph mean that the disc has a high failure rate? If so, is this a high failure rate for ADRs in general? I am so lost.

KBear, that bottom graph is just showing that the ADR can support a higher compressive load then a human disc, nearly 4 times higher.