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Author Topic: Denovo NT  (Read 11960 times)

Offline GSB

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Denovo NT
« on: March 01, 2010, 05:39:23 AM »
My doctor recommended that I have Denovo allograft implantation.  I have the following questions:

1) what is the difference between Denovo NT and ET?
2) is Denovo implantation similar enough to ACI that a surgeon who has performed numerous ACI procedures but never performed Denovo would be competent to perform it?
3)  Is there any information about success of Denovo in clinical trials?
4)  The manufacturer of Denovo claims that there have been no problems with rejections.  Is there a reason for that?  Is there sufficient data to support that?

Thanks

Offline lizlove2110

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Re: Denovo NT
« Reply #1 on: March 19, 2010, 06:09:29 PM »
Let me see if I can help
1. NT=natural tissue (the graft taken from a juvenile donor), ET=engineered tissue (created in a petri dish)
2. The DeNovo procedure is not the same ACI although it serves the same purpose.  In the DeNovo the tissue is glued on the defective area instead of sewn on as in the ACI.  I would work with a doctor who has done this procedure before.  I am having the DeNovo procedure next month in Atlanta and my doctor has done 2 other DeNovo surgeries both within the last 6 months.
3. There is no information about the success of DeNovo because the rehab is  18-24 mos.  I would ask the doctor you select if you can talk to his/her patients directly who have had the procedure.
4. Is there is not enough data to support the claim that no rejections have occurred.  Of the 500 or so procedures that have taken place in the US, a majority of these have been done in the last two years.  The ISTO and Zimmer folks expect to have this data in 2013.

I hope this helps.

Offline GSB

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Re: Denovo NT
« Reply #2 on: March 24, 2010, 05:32:48 PM »
Thank you, very helpful.

The defect I have could be repaired with Microfracture, but as I understand it, doctors are starting to use Denovo as an improvement on MF rather than as a second line of defense where MF fails.  What I am trying to figure out is if the pontential improvements on MF outweight the risks of undergoing a new and not well-documented procedure.  Any thoughts?  Also, were you told 18-24 mo. rehab?  I was told more like 6-9 mo.'s.

Thanks, again. 

Offline nyctri

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Re: Denovo NT
« Reply #3 on: March 31, 2010, 05:35:47 PM »
Hi, I was wondering where you found information on the Denovo ET? A good friend of mine is having denovo done by a guy in NYC who has done 5 in the last  6 months (3 of which on pro football athletes) and was not offered the ET?
Is it better than the NT, or less painful? He was also told he could start sports in 6 months. Thats a big difference from 18 months, why the different amounts?

Offline IR

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Re: Denovo NT
« Reply #4 on: April 08, 2010, 04:24:23 PM »
Denovo ET is still a few years away from the market - similar tissue donor source, but the cells are expanded kind of like the ACI process.  There have been over 900 Denovo NT cases done - latest i have heard.  Rehab shouldn't be anywhere near 18-24 months - i think that might have been a reference to a 2-year outcomes study they are currently running.  There was a paper at AAOS (American Academy of Ortho Surgeons) they handed out this year that talked about the early results of that study - very promising.  And there is much less risk of young cartilage cells (from young donors) being viewed as a foreign object than adult cartilage cells.  All in all, a very simple surgery from a technical standpoint.  I expect rehab to be similar to microfracture at worst.

Offline pfokus

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Re: Denovo NT
« Reply #5 on: April 10, 2010, 09:10:11 AM »
I just had this procedure performed by Dr Farr at OrthoIndy on a 1.2 x 2cm rectangular lesion in the trochlear groove.  Surgery was March 10th so 1 month ago.
There was a previous failed MF done as well.
Chance of rejection is small bc the area doesn't have bloodflow.
Notice when scoped everything is clear and fluid filled but you don't see blood.
This was what I was told was a reason.

24 months is the length of the clinical trial I am in as well.
The benefit of the trial is the MRIs at 3, 6, 12, and 24 months.
Big benefit to me is at 24 month they scope the knee and take a picture of the defect.

Hope that helps.

PS

Offline ajschnelk

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Re: Denovo NT
« Reply #6 on: April 11, 2010, 02:33:29 AM »
Is this and open procedure like ACI?  Do they do any other procedures along with it; like a TTO/HTO?

Offline courtpt8

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Re: Denovo NT
« Reply #7 on: April 29, 2010, 01:55:26 PM »
I had Denovo NT, medial meniscal transplant, lateral meniscal repair, ACL revision all done 12/2008 & have had nothing but great results thus far.  I have regained full ROM, have limited (if any) restrictions, I am biking daily, rollerblading, gardening.....all without pain or any problems.  I would say my results thus far are excellent.  Overall, I am extremely pleased & will be participating in a mini-triathlon in August (My MD said I should be good to run short distances infrequently).  If you have questions, let me know!!  Best of luck to all of you.  I hope  your outcomes are as good as mine!!
1993 ACL
05/1999 Meniscal Repair & Lateral Release
11/1999 Meniscal Repair & Partial Meniscectomy
06/2001 Partial Meniscectomy
08/2003 Partial Meniscectomy
05/2006 Partial Meniscectomy
10/2007 Partial Meniscectomy
07/2008 Stage I Arthroscopy for ACI

Offline ajschnelk

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Re: Denovo NT
« Reply #8 on: April 29, 2010, 02:38:20 PM »
I had Denovo NT, medial meniscal transplant, lateral meniscal repair, ACL revision all done 12/2008 & have had nothing but great results thus far.  I have regained full ROM, have limited (if any) restrictions, I am biking daily, rollerblading, gardening.....all without pain or any problems.  I would say my results thus far are excellent.  Overall, I am extremely pleased & will be participating in a mini-triathlon in August (My MD said I should be good to run short distances infrequently).  If you have questions, let me know!!  Best of luck to all of you.  I hope  your outcomes are as good as mine!!

This is great news regarding the latest cartilage procedure.  If you don't mind me asking, what was the location of your cartilage lesion and size of the defect?  Who did the procedure? 

Offline marcinaz

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Re: Denovo NT
« Reply #9 on: May 03, 2010, 04:13:30 PM »
Am likely having De Novo at the end of the month. Has anyone been able to run after it?
Cheers,

Marc S. Rubin
http://www.10-hours.com

Offline ajschnelk

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Re: Denovo NT
« Reply #10 on: May 03, 2010, 06:07:22 PM »
Hi marc,

It depends on the location if a doc will recommend it or not, but I can tell you that many on this board were able to get back to most activitites, including running, after having ACI.  However, it's a very long recovery period.  Denovo NT is very new and I don't believe there are too many on here, but from  what I know about it, recovery is very similar to the standard ACI procedure.  Has your OS done many Denovo procedures?  What is he/she tellling you?  Personally, I had ACI for a throchlea defect (after a failed mfx in '04) on Dec. '09 and I am hoping to get back to running, biking, and skiing. 

I'll be sure to follow your recovery.  Best of luck!   

Offline hwa

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Re: Denovo NT
« Reply #11 on: September 10, 2010, 01:35:04 PM »
I had the Denovo procedure (juvenile donor cartilage) 5 weeks ago.  Doctor also performed a TTO to raise the kneecap (said raises success rate from 65% to 85%.  Also my knee cap was tight as hell from old ACL surgery.  When doc did scope said defect a lot larger than anticipated.  Size of a silver dollar.  But he had enough donor cartilage to cover the defect.  Usually they just glue it, but he used the artificial patch from the ACI to cover it for added support.  The doc has a lot of these procedures and is participating in a few studies.  He told me that he would do the Denovo verse the ACI.  Since he does the TTO, at 6 months he goes in to take the screws out and looks at the cartilage.  he said it is amazing, grows fast and strong.  A true cartilage verse the ACI which looks like scar tissue.  Also said that should be mature at 8 months, not 12-14 like ACi since they are starting with minced cartilage verse the ACI cells.  Dr. Fleshcli at OrthoCarolina in Charlotte.  I may have spelled his name wrong.  His clinic is participating in a study now with your own cells which is similar procedure to Denovo.  See their website under clinical studies.  Hard to find, but I found it this morning.  Only problem with the TTO is that cannot full weight bear for 5 weeks.  Leg feels great.  In PT, doing a lot of to get it moving.  At 90 degrees now.  I was going to get the procedure in May but the company that supplies the cartilage did not have any.  Same thing the week prior in August, but the day prior, they had it.  Short supply since procedure is becoming popular. 

Offline aajaybird99

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Re: Denovo NT
« Reply #12 on: December 30, 2010, 05:17:39 PM »
For those considering Denovo NT for Articular Cartilage tears:  I had the proceedure done 11 weeks ago today (10-07-2010).  I had an allograft transplant on the right medial condyle (inside bottom of femur bone)  Graft was about 2.5 by 1.5 cm and took two packets of DeNovo stem cells.  I had degenerative wearing in that area and could not participate in sports (golf, basketball, running) without a medial unloading brace on (and even then it was limited).  I am 45 yrs. old but still remain very active in those sports.  After surgery I was totally non-weight bearing for 3 weeks followed by gradual to full over the next 2 1/2 weeks.  I had rehab for 4 weeks (once per week) mainly in the transition from non to full weight bearing.  Rebuilding quad and hamstring strength was and is the complete focus.  I was walking normal at 6 weeks with or without the unloading brace.  Elliptical machine at 7 weeks and have increased from 10 miles per week to 24 miles per week since.  Numbness and swelling in the knee gradually decreased from week 4 and is almost non-existent now in week 11 (starting week 12).  I jogged 150 yards for the first time since way before surgery today without any brace on.  I have video to prove it!  Felt great.  Looking forward to more of same and slow increase.

Key to success with this surgery: Get to a good fighting weight before surgery.  I had a scope meniscus repair last December (year ago).  I was 188 at surgery at 5'10".  After MRI showed this articular tear in July of this year, Doc said to drop weight to help recovery.  I worked hard on elliptical and went to Body Pump class 3 times per week along with lifting heavier only a couple times per week.  Ate right too.  Dropped 16 lbs. prior to surgery on Oct. 7 and felt great going in.  That was and is absolutely the key to this and any other knee surgery in my opinion.  I am now at 172 with a constant goal of 167.  I am working toward the last 5.  Be patient post-op - this is a 4-5" incision and will take time to heal.  Easy for the first 3-4 weeks and stay off it for sure.  The graft will grow quickly but needs that first 3-4 week head start before you get crazy.

I owe a big shout to my friend Marc Rubin at http://www.10-hours.com who went through this surgery before me.  If it weren't for him I would not have done it.  That is why I am sharing my story with everyone here.  This is a good proceedure.  I have seen too many MFX cases fail to even consider that method.  This is truly state-of-the-art stuff with the DeNovo NT Allograft.  Any questions email me jpayne@turfsolutionsgroup.com 

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Re: Denovo NT
« Reply #13 on: January 28, 2011, 04:42:38 AM »
This is an extremely helpful thread.  Thanks to all who contributed.  Keep posting!

Offline cdubb

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Re: Denovo NT
« Reply #14 on: January 28, 2011, 04:52:03 AM »
It is a helpful thread and I'm really just posting to make sure I don't miss anything if somebody else is posting. I'm 12 weeks post patella ACI with a TT and am up in the air about what to push for when it comes time to do my other knee with a similar size defect.  (Left was 2 cm x 2 cm).  My doc that did my ACI also does Denovo NT, so pretty sure I could push for whichever one I think would provide a better outcome.  I'm doing pretty well 12 weeks post op now of patella ACI/TT, so why mess with something else....but others say that Denovo NT is a quicker recovery?  Anybody know of any 5+ year studies out there for Denovo NT in the PF joint?
'01 - R knee chondroplasty and LR
'03 - L knee chondroplasty and LR
Aug '10 - L knee ACI biopsy
Nov '10- L knee patella ACI/AMZ and R knee chondroplasty
Dec '11 -R knee patella DeNovo NT/AMZ and L knee hardware removal

Offline ella5509

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Re: Denovo NT
« Reply #15 on: February 07, 2011, 06:29:44 PM »
Great to hear cdubb is doing well.
ACI procedure is a two stage procedure and very expensive.
Denovo NT is about 3 yrs old and has limited follow up but all of it is very positive. It has been used in the PF, patella femoral, joint successfully. Denovo NT has juvenile stem cells which are able to "grow" much better then adult, over 25, stem cells. When MF, microfracture, is done, the "new" tissue is closer to scar than cartilage. Now, whether the "scar" tissue is any worse then the Denovo NT or ACI, I think is still being debated. If there are any surgeons on this topic, I would love to hear there side of the story.

Offline cdubb

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Re: Denovo NT
« Reply #16 on: February 08, 2011, 01:56:29 AM »
ACI is expensive!  My US Bioservices (Genzyme) EOB, which is the only provider in the country providing the cell expansion services, came in at $61K.  Now...that was billed and not the conracted rate and there are still recons going back and forth between my insurance and US Bioservices...but it's pricey.  Tack on the surgeon, asst surgeon, facility, anesthesia, DME, PT...it's costly...not to mention there is the biopsy scope also.  Wonder how much Denovo NT costs for the cubed juvenile cells?  Denovo ET is only being used in clinical trial at this time.  ET, I believe, is more like traditional ACI, but the cells are from juvenile donor cells.  My doc has clinical trials going on right now to compare various cartilage restoration techniques...unfortunately, with 2 bad knees...I am not a candidate.  You have to have one good knee.

I plan on asking more questions to my doc comparing the two when I'm closer to feeling like I'm ready to do my right knee.
'01 - R knee chondroplasty and LR
'03 - L knee chondroplasty and LR
Aug '10 - L knee ACI biopsy
Nov '10- L knee patella ACI/AMZ and R knee chondroplasty
Dec '11 -R knee patella DeNovo NT/AMZ and L knee hardware removal

Offline swift_ny

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Re: Denovo NT
« Reply #17 on: February 11, 2011, 07:38:16 PM »
Hi - I'm new to the site, although I've been browsing it for a few years as I narrowed down  my surgical options. My knee doc is now recommending the TTO with Denovo donor cartilage (I'm a now-ex marathoner with stage 3 patella chondromalacia that is causing almost daily pain and skewing my body so that I'm now having back pain. Been going on ~10 yrs. I'm a 42-yr-old woman).

I've been trying to find someone on this site with very similar experiences, b/c I'm very concerned about recovery, and, honestly, the TTO scares the you-know-what out of me. Cutting into healthy bone just seems wrong, but every orthopedist I've seen over the past 10 yrs has said it's the conservative surgery of choice for bad patella problems (I have a 1.5+cm hole in there, too). No one else has suggested doing any kind of cartilage repair, citing poor stats.

Denovo is so new that there are no long-term figures for how well it works, but has anyone who has been advised to have a TTO had only Denovo instead? If so, how did it work for you?

If you had just a TTO and nothing else, how are you doing a year or more out? I've read such diverse results... some folks say they are miserable and wish they could go back; others are running 10Ks and saying they should have done it sooner...

Adding to the fun is that I'm scheduled for hip surgery 6 wks before the knee surgery (two tears of the rt labrum and impingement). Both my surgeons are in NYC and considered among "the best," but I've been told by other knee surgeons that my knee guy - the one pushing Denovo or Tru-Fit, which he experiments with - is known for using patients as guinea pigs. That makes me lean toward doing the TTO only, since all the docs recommend it, but from what I've read here, many of you have had docs say what my knee guy has; i.e., that there's no point in doing the TTO if we don't fix the hole while we're in there...

Sorry for the long post and multiple questions; at this point, I feel that anecdotal evidence from other banged-up athletes is what I need to decide which route to take... after all, unlike the surgeons and the companies, there are no agendas here... thanks for any advice or insight...

Offline cdubb

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Re: Denovo NT
« Reply #18 on: February 12, 2011, 01:59:10 AM »
As you can see from my above posts, I had the TT w/ ACI to treat a patella defect.  I think the specifics of your knee mechanics and location of your defect need to be evaluated to determine if a TT is indicated and what kind of TT.  I had an anteromedialization of my tibial tuburcle, more commonly known as a Fulkerson.  ACI vs. Denovo....that is a decision between surgeon and patient.  ACI has more history and Denovo is newer without long term studies, but it is very promising and the grafts appear to be maturing faster than ACI. 

There is another poster on here who is about 2 months out from Denovo NT w/ the TT and she had her surgery in NYC.  You can e-mail her for more specifics.  Her name is Kasia NY or something like that....her diary thread is in post op diaries I believe < 100, but it could be in the 100-300 section.  My diary is in the 100-300 section. 

You can always do the TT only and go back later for the Denovo.  When I had my initial ACI biopsy scope, it was scheduled as "arthroscopy with possible microfracdture, possible ACI biopsy and possible AMZ (what my doc calls the TT).  So, going into surgery, I could have had just a scope and biopsy or the TT could have potentially been done that day depending on the findings going in.  I asked it to be done under spinal, so I could be awake and involved in the decision process. As my Dr. was scoping me, the defect that showed on the MRI as lateral, was actually central.  So, he rattled off some statistics about an isolated AMZ only carrying a 50% success rate, but combined with the ACI it goes up to 80% or above....so he took his biospy and bailed.  We then went back 2 months later for the ACI/AMZ procedure.  So...really...it could be a game day decision.  Bonus is with Denovo, you don't need the biopsy scope, but I'm sure that there are some insurance authorizations that need to be put into place ahead of time.

Now....being able to return to running marathons....that may not be viable no matter what decision you make.  I'm a former college softball player, but have no aspirations of returning to competitive sport...I just needed to get through my day without several instances daily of sharp anterior knee pain stopping me in my tracks.  If I can return to some light slow pitch softball or easy recreational tennis..that's just bonus!
'01 - R knee chondroplasty and LR
'03 - L knee chondroplasty and LR
Aug '10 - L knee ACI biopsy
Nov '10- L knee patella ACI/AMZ and R knee chondroplasty
Dec '11 -R knee patella DeNovo NT/AMZ and L knee hardware removal

Offline mfactor

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Re: Denovo NT
« Reply #19 on: March 14, 2011, 06:46:07 PM »
For all those looking for denovo information. I am undergoing the procedure on my l patella and part of trochlear groove tomorrow 3/15/11.  Will keep all posted on recovery.  I am an "older" (56)but still very active in racquetball and hope to run short distances again at some time. over the past year it has become increasingly difficult to move from sit to stand to sit , steps are difficult and sports activities are limited.  Was scoped in early Feb and found left lat patellar facet is deteriorated with bone visible.  plan is to complete l knee first then possibly r about 3 months later.  md is Dr Norman Marcus as Virgina Cartilage Institute.  I like him,-direct, to the point and willing to explain and answer questions.  Further updates to follow.  Feel free to Email me at mc.bickley@hotmail.com.   

Offline skierboy

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Re: Denovo NT
« Reply #20 on: March 23, 2011, 07:27:54 PM »
MC--

Let the group know how your procedure went.  I am also a patient of Dr. Marcus in Springfield, VA and his Virginia Cartilage Institute.  See http://www.normanmarcusmd.com/.  My DeNovo NT procedure originally scheduled for early April has had to be postponed several months due to other medical issues not relating to the problem knee.  I do so want to get this done and get back on my traditional exercise regimen.  Dr. Marcus did a microfracture on my left knee over two years ago, and it has been overall successful.  But I know that the fiberous cartilage that MF creates is not as durable as the articular cartilage that should be generated by a DeNovo NT allograft.
Nov 04 -- LK debridement
Sep 08 -- LK microfracture
May 11 -- RK meniscus trim
Sep 11 -- LK TissueGene-C injection

Offline kitkool

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Re: Denovo NT
« Reply #21 on: April 12, 2011, 02:39:16 PM »
mfactor and Skierboy.  I had Denovo NT done on my right knee with Dr. Marcus on 1/4/2011. So this is my 14th week after surgery and I am feeling really good. I am able to walk normally and quickly without any pain. I have been cleared to do elliptical and biking. I followed what Dr. Marcus told me and have not attempted to kneel or squat. The only thing I currently have to take my time on is walk down steps. The motion in my knee doesn't seem as fluid when taking steps down but it has improved from a lot than before. I did not have any issues post surgery but was on crutches for 5 weeks and then 1 crutch/cane for about a week. I use to get pain from walking 10 -15 mins pre-surgery but now I have done that a few times and have no pain what so ever. Only thing is during some bad weather the knee does get slightly tender.

I went to the PT right next to Dr. Marcus's office and I have to say that they really helped me a lot with my recovery. The place is a bit small but the staff is great.

Let me know if anyone has any questions and I will try my best to answer them.

Offline skierboy

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Re: Denovo NT
« Reply #22 on: April 22, 2011, 09:48:02 PM »
Kitkool--

Great to hear you are progressing well after DeNovo NT treatment by Dr. Marcus earlier this month.  I am still in the process of scheduling my surgery with him.  Working out the insurance issues has been a hassle.  But I want to get this work done regardless whether my insurance company will cover a portion or not.

I'm well familiar with the non-chain PT staff that operates in the same suite as Dr. Marcus.  That's who I used when I did my rehab from the doctor's microfracture on my LK two and a half years ago.

Do keep posting on how your recovery progresses.
Nov 04 -- LK debridement
Sep 08 -- LK microfracture
May 11 -- RK meniscus trim
Sep 11 -- LK TissueGene-C injection