Yesterday afternoon, I showed up at my knee doctor’s office for my 2 year post-surgery check in. Most of the time, I hardly notice or remember my knee surgery until someone asks me about my knees or I head back to my doctor for a check in. And because I am participating in a research study, I’m following back up with my doctor far more than if I hadn’t participated.
Two and a half years ago when deciding about my surgery options, I had no idea participating in a medical study was something I could even do or what it meant to sign up. But it’s something I get asked about frequently – by email and in real life – and I thought I’d share what my experience has been.
Participating In The DeNovo NT Medical Study
Right off the bat, I’m gonna say that each study is different and this is just my experience.
My doctor had presented the ‘usual suspects’ as potential courses of action for treating my osteochondritis dissecans in my knee – microfracture (drilling tiny holes and letting the blood form scar cartilage), the OATS procedure (harvesting my own cartilage to regrow and reinsert) or to ‘just stop doing the things that aggravated my knees’. None were my favorite option and at the next appointment, he suggested that I might be a good fit for this medical research study for a new product, the DeNovo NT (NT = Natural Tissue = donor cartilage) by Zimmer.
After reviewing what DeNovo would offer, I definitely wanted to participate. The DeNovo NT is a cartilage graft from a juvenile donor so the cartilage is still young and growing. It ‘sticks’ better than scar tissue cartilage which is what the microfracture offers (and what I’d done in the past). And the best part was that because DeNovo was just cleaning the back junk out and adding fresh new junk in; if it didn’t work, I hadn’t caused more damage to my knees by drilling tiny holes into them.
Studies are in various stages of FDA approval and it’s important to now what stage your product is in before joining. I knew that I didn’t want to be the first round of guinea pigs – I wanted Zimmer to have it mostly down pat, just looking for more data which is exactly the phase DeNovo was in. Zimmer had FDA approval for DeNovo and shortly after my study, it was available for any patient who fit the criteria to ask for it. What Zimmer wants with my study is long-term data and real life experiences for osteochondritis dissecans of the knee.
I agreed to join the study and my doctor reviewed what my commitment would entail. Pre-surgery, I’d have to sign an agreement that I was participating on my own volition. It also prescribed that before surgery, I’d fill out a baseline questionnaire and would follow up with my doctor after surgery at 1 month, 6 months, 12 months, 18 months and yearly for a total of 5 years.
But my participation was still up in the air – even until surgery! My doctor thought I was a great fit and my MRI showed that my lesions (part of my cartilage that was disintegrating) were the ‘right size’ but my doc wouldn’t know until he was looking at my actual cartilage if I’d fit the requirements. Lucky for me, I did fit the requirements because I was not too jazzed about option B (microfracture).
Is there compensation?
In some studies where surgery is involved, surgery could be ‘free’ for the patient. My surgery was not one of those surgeries. I paid for surgery myself and made it a point to have them both in the same calendar year so both surgeries would count against one out-of-pocket max. Surgery and initial follow up were business as usual – the study prescribed that I would go through surgery and routine follow up like any other knee surgery patient.
But every follow up after that, I’m compensated for my time. It’s not much ($50 per leg) but it’s a nice token of appreciation for me taking the time to drive to my doctor’s office at their necessary intervals.
What happens in these follow ups, months and years later?
Remember that baseline questionnaire I completed pre-surgery, I am completing that same questionnaire. Over and over again. It’s about 15 pages of questions about how my knee feels and if my activities have been limited. Because my surgeries were completed within 3 months of each other, I’m able to complete both follow ups in the same office visit which is really nice. Kudos to Dr. Hewitt for making that work for me! Fortunately for me, the questionnaires have been pretty simple to complete – I’ve had no problems with my knees post surgery! (Except for snowshoeing on men’s snowshoes but that’s an easy fix)
Why did I participate?
Ultimately, I participated because I wanted to know I helped contribute to a product that could go on to help people like me who are affected with Osteochondritis Dissecans. Whether it worked or not, Zimmer would get data on what a 26 year old, active female’s experience was and what they can do better in the future.
And I blogged about the whole process so others of you dealing with osteochondritis dissecans know you aren’t alone and that you can still be active and do things you love. And because when I was considering surgery options, I couldn’t find a real person on the internet who also faced surgery for osteochondritis dissecans and only one person who had done the DeNovo surgery (hi Marc!). So I participated and started blogging about it in hopes that I can bring comfort or inspiration to other people who are in the shoes I was wearing a couple of years ago.
tldr: I participated in a medical study and it’s been neat. Helping people! YAY!