ADR clinical trial candidate

[Rick]

Hi, this is my first post here. I have been fighting Lumbar spine problems for about 3 years now. Not sure what started the process but I'm sure running, hiking with 60lbs packs and skiing all contributed to my L5-S1 disc protruding and eventually rupturing. I have had two failed micro discectomies Aug 09 and Nov 09. The second one failed 2 weeks ago. My doc is recommending Fusion and I asked him about ADR and he said that was an option but insurance does not cover it. I've researched the web and found the Freedom clinical trial and I am in the process of getting my records mailed out to one of the trial sites to see if I am a candidate. I have 2 questions that maybe someone can give me insight into. 1. Has a risk assesment been done comparing the risk/benifits of fusion to ADR? 2. I noticed the exclusion criteria for the FDR study included "Non-contained or extruded herniated nucleus pulposus". Well my disc did rupture and extrude some of the nucleus. I spoke with the research director and she said not to be concerned with that yet and the surgeon will make a final determination. Does anyone know why this would be an exclusion criteria and has anyone successfully entered the program with this criteria? I am really hoping I can get into the ADR trial because fusion is irrevesable and sounds like you are prone to further complications down the road. I am coming to realize that back problems with be a permenant part of my life now so it's more important on how i manage them.

Thanks for the support forum, this has helped me a lot!

[KBear]

Rick,
I think the best thing to do is find a really good surgeon and have them tell you more. It all varies so much person to person. Whereas, ADR was best for me, others it can be a disaster for..... same for fusion. I know the clinical criteria can be very confusing too. Like, my MRI report said moderate facet degeneration, which would disqualify me from a clinical trial; but all 3 surgeons I saw said it was mild and that I was a perfect ADR canidate. It is my understanding that a surgeon looks at your MRI images in a different way than the radiologist, so their opinion can be very different.
I also tried to get in the Freedom Disc Trial, and met all of the clinical criteria; but was disqualified due to litigation regarding my spine. I ended up being in the Active L trial.

Good Luck & Keep Us Updated,
Kathy

[Justin]

Hi Rick,

Welcome to the Spine Patient Society!

Sorry you have to be here, but we are here to help.

I have had two failed micro discectomies Aug 09 and Nov 09. The second one failed 2 weeks ago.

For most studies, the exclusion criteria states that the patient has not had spine surgeries in the past (I'm not sure on the Freedom trial...I will have to double check this).

1. Has a risk assesment been done comparing the risk/benifits of fusion to ADR?

There are many studies on the risk / benefits of artificial disc replacement surgery compared to fusion. The Education, Research and Spine Publications Forum has a ton of good information.

2. I noticed the exclusion criteria for the FDR study included "Non-contained or extruded herniated nucleus pulposus". Well my disc did rupture and extrude some of the nucleus. I spoke with the research director and she said not to be concerned with that yet and the surgeon will make a final determination. Does anyone know why this would be an exclusion criteria and has anyone successfully entered the program with this criteria?

I believe this is an exclusion to the study because non-contained or extruded herniated nucleus can lead to increased degenerative changes and localized tissue remodeling is subsequently affected. Also, the study wants to include "good" study subjects (and minimize variables that might relate to degenerative changes) to help study data.

I am really hoping I can get into the ADR trial because fusion is irrevesable and sounds like you are prone to further complications down the road. I am coming to realize that back problems with be a permenant part of my life now so it's more important on how i manage them.

Fusion and artificial disc replacement surgery are "irreversible." They both burn bridges so to speak. Artificial disc replacement can be revised to a fusion down the road, but doing so is extremely difficult and can pose significant risk to the patient (read: complications from extracting a "failed" ADR could result in death). I say this because a few years ago it was widely accepted by the Spine Patient community that ADR could "just be fused over" if a device fails.

I've spoken with many Spine Patients that have done well with ADR and fusion at L5/S1. Thanks for joining us and I do hope we can help support you.

[scduggan]

Hello Rick,
I am so glad you found this site. I do not have any knowledge about the exclusion you were speaking of. However, I am 6 days post-op from ADR surgery at Texas Back Institute in Plano. I was enrolled in the trial and received the Freedom disc at L4/L5. Please keep us posted. Let me know if there is anything about the trial and TBI that I could answer from a patient standpoint. Keep your chin up and keep snooping around until you find what is right for you.

CD

[Justin]

For most studies, the exclusion criteria states that the patient has not had spine surgeries in the past (I'm not sure on the Freedom trial...I will have to double check this).

Hi Rick,

I just looked at the Inclusion / Exclusion criteria for the Freedom Lumbar Disc Trial and it only mentions "prior fusion at level" as an exclusion.

BTW here's the link to the Inclusion / Exclusion criteria for the Freedom Lumbar Disc Trial for those interested: Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease (FLD).

[Rick]

Still have not heard back from the Clinical site in Nebraska on whether I'm a candidate for the Freedom Trial. I hope to hear something this week otherwise I may have to resort to the fusion route. The pain is unbearable at times and is now impacting my work and daily life. Is there a significant risk of taking too much Ibprofen over a period of time? I'm at 10 200mg tabs/day (2 at a time). I have backed off for a couple of days but it just makes for a miseable day. I take vicodens at night so I don't impact my work. I can't imagine people living with this kind of pain.

[Justin]

Still have not heard back from the Clinical site in Nebraska on whether I'm a candidate for the Freedom Trial. I hope to hear something this week otherwise I may have to resort to the fusion route. The pain is unbearable at times and is now impacting my work and daily life. Is there a significant risk of taking too much Ibprofen over a period of time? I'm at 10 200mg tabs/day (2 at a time). I have backed off for a couple of days but it just makes for a miseable day. I take vicodens at night so I don't impact my work. I can't imagine people living with this kind of pain.

Hi Rick,

I hope you hear something soon. Too much ibuprofen is definitely damaging on your stomach and kidneys.