Accepted into the Freedom ADR trial

[Rick]

I just got a call from the Nebraska Foundation for Spinal Research and they said my records indicate I am a good candidate for the Freedom ADR trial. We are working out the details of scheduling since I have to fly from Milwaukee to Omaha but it may happen as soon as Easter week. I won't have much time to meet and discuss the pro's and cons of this type of surgery with the Doc. I will fly out on a Monday, meet with the surgical team Tuesday and have the surgery Wednesday. I did speak with the PA and she answered most of my questions. I have been going over and over in my head on whether to do Fusion or ADR I guess this is a personal decision that no one else can really answer. Both procedures have upside and downside.

I do have a question for anyone who has been in a similar trial. How much of the cost is out of pocket and how much is covered by the clinical trial program? I know broadly, the surgery is covered by the program but I heard folks talking about insurance problems while in a similar program.

Also a question to those who have had ADR, what does recovery time look like? I am a healthy athletic male of 52 years and have no other complications. I'm hoping to get back on my Harley sometime this summer.

This is a great site and I appreciate everyone's support here!

[WPKat]

Congratulations!

How exciting!

Sorry, Rick, I don't have any answers for you, but wanted to wish you a good journey.



K

[KBear]

That's Awesome!! So happy for you!

Now to try and answer some of your questions....
This decision for ADR vs. fusion is a hard one, one of the biggest factors for me in going into adr was age, I was only 29 and had been told by literally every doctor I had seen in 3 years to never have a fusion. I saw 3 surgeons pre-op and they all felt ADR was best for me. I researched and then took the plunge. However, as many on here can vouch for, ADR is not for everyone and it can't just be undone and fused.... it's not that easy. Not saying that to scare you; but really for everyone reading this. I personally believe that those of us in clinical trials are screened way more and to a more stringent criteria than those not in a trial, because of not only the FDA rules; but they want you to have a good result, so their product gets FDA approved, thus making them loads of cash. So, if I were you, I would feel confident that you are a great canidate, or you wouldn't have qualified for the trial.

I also flew out of state for my surgery. I flew once and met the surgeon, signed all my paperwork, etc. Then the next time, saw the surgeon the day before and had surgery the next day. I had researched him and felt very comfortable with him. I really didn't believe it was happening until I woke up on the recovery bed.

On recovery, ask, beg and plead for an epidural during and after surgery. I did not have this and I literally prayed to die for 2 days the pain was so bad. I was put in ICU for the first 36 hours of recovery, as my blood pressure was way high from me being in so much pain. I am very tolerant of medication, always have been, so it was very hard for them to treat my pain. I was getting 2-10mg oxy's and shots of morphine every 4 hours and they were not doing anything for the pain. I was very naive going into surgery, thinking that since I was young, that I was going to heal quicker and be back to me in 8 weeks.... boy was I wrong. I'm at a year and just now feeling like myself. The first 6 weeks are the hardest, though each day gets a little better than the last. Read the what you need post-op thread, it's a life saver.

On the costs of a clinical trial. It depends on each trial and even then varies location to location. For instance, I was in the Active L trial. I had surgery and signed up in Miami, FL. My regular dr was at Texas Back in Plano, TX, and they had also participated in that trial; but had already done the maximum number of patients allowed by the time I signed up. So, I had surgery in Miami and then was 'transferred' to TBI for follow-up. In Plano, the patients that had the surgery were responsible for all of their follow up visits and x-rays, in Miami that was paid for by the study. In Plano, there were no 'incentives' to return for follow up visits, in Miami, they give $100 Amex gift card at your yearly visits for coming. Since I signed up in Miami, the study agreed to continue to pay all my follow up care and I get the gift card at my yearly visits. The study even paid my pre-op visits to the surgeon; but not the chest x-rays and bloodwork I had to do. I'm not sure how much the paying of actual surgery and hospital time was different in each place. I do know that they did bill my insurance, my insurance actually paid some of it, then the study paid the rest. I received 1 bill for radiology for $49 that I was responsible for and that was it. However, I have heard of patients being responsible for alot more than that. My main surgery costs was hotel, flights (after my husband had to leave, I paid for 2 of my friends to fly out and 'take care of me' and rental car.)

Good Luck & so happy for you!!!

[Rick]

Wow! Kbear that sounds kinda scary. I have been through two surgeries (microdiscectomies) and came out of both in fair shape. A little more pain on the second one due to being more invasive. Morphine didn't do anything for pain but one Hydrocodone worked well. I also recovered on the quicker side of average. I was back at work in 2 weeks. I hope my recovery goes quicker than your did as I would like to get back on my bike this summer. But I have dealt with this pain for 3 years now and I am ready to move on.

Hopefully you finish your recovery quickly. Thanks for your honest insite. Keep it coming.

[Rick]

KBear,

What Kind of pain were you feeling post-op? Same as befoe or new pain? Was it worse post surgery? How long did you have to stay on pain meds?

[Justin]

Congrats Rick! KBear pretty much covered everything. The first 6 weeks can be tough and to be safe, patients are advised to avoid "high-impact" activities / lifting / twisting / low-level bending for the first 8 to 12 weeks. This time is crucial for bone remodeling around the artificial disc (osteointegration).

Keep us posted! :thumpup:

[linda]

Hey Rick,
Congratulations on getting accepted into the trial. I am also in the trial and have been for about a year. I had to reenroll in Oct. because evidently it expires after 6 months and you have to reenroll. From my understanding the study covers the surgery /hospital charges and I will have to pay my out of pocket on my insurance policy which for me will be about 5,000. However, we changed from United to Blue Cross at work and I think my out of pocket could be less. I have my packet of all this info that I had to sign for the study and if you have access to a fax machine I could fax it to you tomorrow. It has all of the info in it. I think my insurance will cover the vascular surgeon part but I could be totally wrong on this too. Another thing that could be different is the fact that my study is in NC at a specialty hospital but who knows - it could be universal since it is sponsored by Axiomed. I hope this helps some. I'm also on the fence about fusion/ADR because my last disc is gone. Everyday I'm getting closer to making this decision and getting it over with because the pain is getting the best of whatever is left of me. Good luck!
Linda

[linda]

Rick,
I found my packet and it sounds like there could be more charges than I thought - here goes part of it:

The costs of your surgical treatment, which will include you hospital stay, the carges for the study surgeon, and other physcians (general surgeons and anesthesia) directly related to the spinal surgery, will be billed to you and/or your ins carrier. If your insurance carrier pays for these services, you will be responsible for for any applicable co-insurance and/or deductibles. If you insurance carrier denies the surgeon fees, hospital fees, general surgeon fees or anesthesia fees, the sponsor will cover the fees mentioned above that were not covered by the insurance carrier. The sponsor will also cover the cost of the study device used. Additional physician and/or professional services that may be performed before and during your hospital stay (such as the services of a pathologist, an internist, hosptial urologist, radiology reading) will be billed to you and/or your insurance co. If your insurance pays for the services you will be billed for any applicable co-pays and/or deductibles.

Following your surgery, you and your insurance will be billed for any after surgery meds, follow up visits, x-rays, PT. diagnostic tests and/or treatments. Ask your doctor to discuss the costs that may or may not be covered by the sponsor. This includes the cost of treating possible side effects. Otherwise, you might have unexpected expenses from being in this study.

This is word for word so I hope this helps. This packet is 13 pages long so let me know if you would like a copy.
Linda

[scduggan]

Dear Rick,
I am exactly three weeks post-op today in the same trial. I am sure you know the trial is multi-site. I had to travel from Nashville to Plano(Dallas) for my surgery. So far everything has been wonderful with my dealings with Texas Back Institute. There were a LOT of hoops to jump through but I was so excited I met the criteria I did not mind. The surgeon fees and the hospitalization were covered by AxioMed. I had an approach surgeon and Dr. Zigler was the spine surgeon. There may have even been an assitant. I stayed in the hospital three days and two nights. My insurance (so far) is covering everything else. By this I mean doctor visits and x-rays. I even just received a letter from my insurance verifying coverage on my brace.

As for the surgery I found the hospital stay to be pretty great. The worst pain I had was when I woke up in the recovery room. They were able to get me more comfortable rather quickly. I had a morphine pump for the first 24 hours then hydrocodone and valium for the rest of the stay. It is true they get you up that first day to walk. This is scary but I was pleasantly surprised to find I was very stable on my feet. I was expecting a lightning bolt...but felt nothing at all.

I am doing really well now. I am taking hydrocodone and skelaxin....still on schedule. There have been a couple of times I have stretched it on the timing but that does not bode well. I did have some days the first two weeks with some pretty righteous pain. I think I am doing well because I am really taking it easy. This is good and bad. It is good to finally have an excuse to take it easy instead of pushing on through EVERY DAY. It is bad because too much rest can make you feel like a big slug. I am seeing how easy it would be to hurt myself. I also see why most people say it really takes a year to really know what your result is from ADR.

I got the Freedom disc and I am really excited about that. My old disc pain is gone and I hope it stays gone. My back gets tired REALLY easily. I am excited for you and your upcoming surgery. I wanted to chime in because it really helps to hear about everyone and their story. Are you nervous? You are probably just ready to get on with it. Your date will be here before you know it. Everyone is different but hopefully you will be on your bike this summer, even if it is just for short rides. Please feel free to PM me if you have any more questions about the trial.

[KBear]

It was not the back pain that hurt when I woke up. It was my incision and it seemed like every muscle in my body. It hurt to raise my arms and my legs hurt like crazy too. I am a very compliant person, yet I refused to even attempt to get up the first day, the pain was just too much. I had had previous procedures and an IDET surgery prior, so wasn't expecting this too be much. I thought, I'm young, I'm in good shape and of a healthy weight, no biggie. I had no idea how major this surgery was. The nurse told me that the only thing more major than ADR was open heart surgery. I'm not trying to scare you or anyone, just wanting to stress this is major surgery. I have heard stories both ways on the pain. Some people have awesome pain control and feel great in the hospital, then get home and hurt more than in the hospital. I have major pain control issues, which I am sure played into my pain. When I go to the dentist, they can not get my mouth numb enough... I have had to 'tough out' a root canal more than once. Apparently, I have a great liver, kidneys and metabolism; so I process the medication quickly. So, I'm not the 'norm' either.... just the other extreme.