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Author Topic: From start to finish.. CaReS in US...clinical trial..  (Read 26202 times)

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Offline kalyjoe

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From start to finish.. CaReS in US...clinical trial..
« on: November 16, 2006, 07:40:35 PM »
Had microfracture two years ago and it hasn't held up.  OS suggested OATS but after doing much research, I decided with my activity level, OATS wouldn't last too long either and I didn't want to end up in the same spot AGAIN.  New OS told me about a study....a clinical trial not yet approved by the FDA to use the CaReS system to repair my defect.  I'm the 10th of a 10 person study to have it done in the US.  You can read about it here:

http://www.ars-arthro.de/downloads/ak_pdfs/ak_patbrosch_eng_v6.pdf
 
http://www.arthro-kinetics.com/product_knee_1.php


Had my harvesting surgery today in the early morning.  I was the first patient, so it was nice...I was in and out.   This surgery is simply using the scope to remove a few grafts of cartilage to send to Austria to harvest into a membrane to later attach to my bone to fill in my defect.  I go back for that surgery exactly two weeks from today:  November 30th.  I've got pictures from today, so I will upload and post them when I can get to that. 

So far, so good.  I'm tired and loopy but so far not feeling much pain.  Taking Percocet and elevating the knee while dozing on and off in front of the TV.  Was told to weight bear as tolerated and by Saturday I should be pretty much back to normal.  Not looking forward to being laid up over the holidays, but hopeful that this procedure will give me a permanent "fix" and I can use my knee normally without the constant fear of ruining it.  The study concludes in three years...so I will try to be diligent about posting on here as I'm told that after the results of this trial are in, they will do a second phase where they open it up to many more people and as long as all goes well, it will be standard procedure for articular cartilage damage. 

Kristi
« Last Edit: November 17, 2006, 12:46:43 AM by kalyjoe »
2 x 1.2 cm defect of right medial femoral condyle
Microfracture, right knee, October 18, 2004.
MACI using CaReS, same knee, November 30, 2006

Offline kalyjoe

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Re: From start to finish.. CaReS in US...clinical trial..
« Reply #1 on: November 18, 2006, 01:37:49 PM »
Two days after my harvesting surgery and I'm still aching.  For some crazy reason, I had in my head I'd be back to normal today and could go out dancing.  Not so!  My knee is still swollen and stiff and I'm still using the crutches to partial weight bear.  I'm feeling some anxiety about the second surgery now because I'm remembering how much pain there really is those first few days and with that one being an open knee procedure, it's bound to be worse.  Plus, I really hate being tied down and relying on everyone for everything.  What a yucky time to be laid up, over the holidays.  Part of me is saying "what were you thinking?" when the other part of me knows this is a great opportunity that I have to take advantage of. 

Kristi
2 x 1.2 cm defect of right medial femoral condyle
Microfracture, right knee, October 18, 2004.
MACI using CaReS, same knee, November 30, 2006

Offline bioprof

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Re: From start to finish.. CaReS in US...clinical trial..
« Reply #2 on: November 19, 2006, 02:10:53 PM »
Kristi,

I bet the "what were you thinking" feeling is one most of us have had who've gone through ACI, etc.  I know I did. You're right, you must look at the long term benefit.  None of us likes to be completely dependent on others...that was (and still is) a particularly difficult part for me.   I'm married with two young children, so my wife and kids have also gone through a big adjustment period. 

I found that setting realistic goals, "baby steps",  has helped me get through the long road to recovery.  I find my OS's goals and timetable to be overly optimistic, perhaps that's his way of keeping morale high.  My PT is much more conservative.  It was nice to hear that I would be full WB by weeks 10 - 12, but when that didn't happen, there was a let down.  So now I listen closely to what my knee and the rest of my body are saying.  Then and only then do I move forward.  With that said, I threw away my 2nd crutch yesterday-13 weeks post implant (good bye and good riddance!).

Here's to dancing in the future!

Mike



 
8/05 - Cortisone injection, L. knee
10/05 - Meniscus repair, microfracture, L. knee
7/06 - Arthroscopy, Carticel biopsy, L. knee
8/06 - ACI, L. knee
5/07 - L. knee arthroscopy; post-ACI "clean up"

Offline kalyjoe

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Re: From start to finish.. CaReS in US...clinical trial..
« Reply #3 on: November 21, 2006, 02:07:04 AM »
Wow!  Congrats on being crutch free finally.  I'm sure that feels very liberating.  Thanks for sharing there is a light at the end of the tunnel.  I remember with my microfracture I had the six week point in my mind.....that at six weeks I'd ditch the crutches and be back to my old self.  What a shock that was to still be PWB for quite a few weeks.  So, I'm trying to remain more realistic with this one and figure on 12 plus good weeks on crutches in some way or another.  If I'm off sooner....great.  But, I'm not going to hold my breath.  I also have two school age children who I pretty much drive around everywhere, so not being able to drive is really stressing me out.  (It's my right leg.)  I'm trying to accept that it's okay to depend on other parents to drop my kids off or pick them up as I'm always willing to help out when someone else needs it.  It seems to be a lot harder to accept help though, then it is to give it.   ;)

Feeling good today.  Walking pretty much "normal" except for up and down steps as my knee seems to catch a bit if I fully extend or bend completely.  I'm heading to the gym tomorrow to lift and attempt walking on the treadmill.   We'll see how that goes.  I'd like to continue to build up my quads as I know the atrophy that sets in almost immediately following the surgery and being NWB. 

Let me know when you finally head out to dance!  I'll be cheering you on and hopefully not that far behind you. 

Kristi
2 x 1.2 cm defect of right medial femoral condyle
Microfracture, right knee, October 18, 2004.
MACI using CaReS, same knee, November 30, 2006

Offline gammyknee

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Re: From start to finish.. CaReS in US...clinical trial..
« Reply #4 on: November 27, 2006, 12:58:37 PM »
Hi Kristi

Hope you're feeling better. To be honest I was quite surprised the first few days after my harvest with how sore it was but then it seemed to get much better all of a sudden so you should be OK.

I've posted a more detailed updtae of how I'm feeling but in short: I'm no longer loopy on drugs (I was really out of it for a while) and 10 days post-op the pain level is very good  :) -my knee is more tight and stiff than painful, but I have to be more disciplined in terms of doing the bending exercises - I think having a CPM should really help you with that.

On a final note I'm still amazed you're going home on the day of the op - I know I stayed in a bit longer than necessary to use the CPM but there's no way I would have been able to go home within 3 days - Day1 I was out of it and connected to a morphine pump, oxygen (to counteract the effect of morphine which apparently reduces your respiratory rate) and a saline drip to keep me hydrated, :'(   Day 2 I was moving very small distances on my crutches (i.e. about 10 feet form bed to toilet) and the pain was very intense.

Offline kalyjoe

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Re: From start to finish.. CaReS in US...clinical trial..
« Reply #5 on: November 27, 2006, 03:00:27 PM »
Four days until the big day and basically I'm beyond stressed out trying to get everything done that I need to do before being laid up.  I'm focused on stupid things like getting my ceiling fans dusted and cleaning out the kids closets.  I guess mentally I need to feel like things are "in order" so I can just focus on recovering and not try to do stuff.  With my microfracture, I used to vacuum on one leg and pretty much hop doing everything I needed to do.  But I know with my leg being in an immobilizer, I won't be able to do all that.  Plus, I just know the bathroom will not get cleaned the same. 

I had my followup/pre-op visit last Wednesday and had my stitches removed and received all my information for the upcoming surgery.  I will come home the same day, but instead of having an ice pack on top of my dressings, I will have a portable ice unit which runs cold water under my dressings.  I won't be able to even remove the bandages for the first week which makes me anxious b/c I'm trying to figure out how I will shower like that.  I suppose a bath would work better, but I guess I'll deal with those logisitcs when I get there.   Plus, not sure how I feel about having all this stuff attached to my knee (I've got the CPM machine coming too)...how in the world will I get around?  My husband has Thursday and Friday off and then he'll be home the whole weekend so I'm hoping by Monday I'll be okay to be home by myself.  I've got Percocet to keep me comfortable and plan on using that as needed. 

I finally went out dancing on Friday night.  My knee is still sore from my first surgery, but I managed to hop on one leg and still have fun.  At least I got one more night in before I'm down for awhile.   ;D 

Will jump on to report on my condition as soon as I'm able after my surgery.

Kristi
2 x 1.2 cm defect of right medial femoral condyle
Microfracture, right knee, October 18, 2004.
MACI using CaReS, same knee, November 30, 2006

Offline gammyknee

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Re: From start to finish.. CaReS in US...clinical trial..
« Reply #6 on: November 27, 2006, 08:41:22 PM »
Hi Kristi

I'm sorry you're feeling so stressed but completely understand. You seem to have a good attitude about thinking long term but the reality is that you can't help more negative short term thoughts creeping in every now and then - it's normal.

In terms of bathing / showering you may have to get your head around not doing either for a couple of weeks. I know this sounds gross but I'm doing pretty well perching on the side of the bath with brace off while washing thoroughly from wash basin and washing hair under tap (faucet). Not ideal to say the least but it's definitely possible to stay pretty clean and hygienic - it's not worth risking twisting your knee or falling get in and out of bath / shower until you're more steady on feet.

As for 'water thing' and CPM you sound very resourceful and I'm sure you'll cope. Think good thoughts and if there's anything you want to check or if you just want to express your anxieties to someone who understands, without worrying your husband, feel free.

Offline kalyjoe

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Re: From start to finish.. CaReS in US...clinical trial..
« Reply #7 on: December 01, 2006, 02:02:41 PM »
Well, I'm home and alive.   Had the surgery at 7:30am, was in recovery by 9am and on the road on the way home by 10:15 am.  Slept pretty much on and off all day yesterday and am taking Percocet and ibuprofen on a regular basis.  The pain is much worse than it was with my microfracture and even shifting on the couch causes me to suck in my breath.  When I'm on the meds, it's not so bad, but they seem to wear off about 30 minutes before the next scheduled dose, so I pretty much clock watch and try to be as still as possible for that period of time.  When I'm up to go to the bathroom or whatever, the pain is even worse....I think it's all the weight on my leg (ice therapy unit, brace, dressing).  The ice therapy unit is great.   It really helps keep the pain at bay and I can tell when the water's getting warm because the pain escalates.  The CPM machine is getting delivered to my home today and I will start using that for six hours a day starting tomorrow. 

I'm having some anxiety regarding next week, when my husband goes back to work.  I won't be able to keep the ice unit filled by myself, but hopefully with friends stopping over, they won't mind me putting them to work.  ;)  I hate being so dependent on people and yes, struggle with those feelings of guilt that my husband is doing everything for me.  I even woke him up in the middle of the night to refill my ice.  But...I'd do the same for him, so I'm just trying to count my blessings and allow people to help me. 

Looking forward to this long recovery being over, but for now just trying to focus on getting over this first week of major pain.  I'll keep you posted!

Kristi
2 x 1.2 cm defect of right medial femoral condyle
Microfracture, right knee, October 18, 2004.
MACI using CaReS, same knee, November 30, 2006

Offline bioprof

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Re: From start to finish.. CaReS in US...clinical trial..
« Reply #8 on: December 02, 2006, 04:34:05 PM »
Welcome "home" Kristi!  I hope your recovery is progressing well.  As one of my friends stated, your pain from now on is "healing pain."  That may be a bit hokey sounding, but it is true.  Without getting too personal and speaking as a married man, I recommend that whenever you're up to it that you let your husband "know" how much you appreciate his help AND "show" him that you appreciate him more than just a caretaker. 

Mike
8/05 - Cortisone injection, L. knee
10/05 - Meniscus repair, microfracture, L. knee
7/06 - Arthroscopy, Carticel biopsy, L. knee
8/06 - ACI, L. knee
5/07 - L. knee arthroscopy; post-ACI "clean up"

Offline kalyjoe

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Re: From start to finish.. CaReS in US...clinical trial..
« Reply #9 on: December 02, 2006, 11:47:52 PM »
Thanks Mike.  My husband knows how much I appreciate all that he is doing for me and knows that when I can "show" him how much it means to me, I will. I trust your wife has a countless supply of backrubs for all the help she gave you during this difficult time?   ;)

Used the CPM machine for the first time today and it actually felt kind of nice.  My leg feels so cramped up from being in one spot that being able to take it out of the immobilizer and move it really felt good.  It was a relief to stretch it some.  I used it  for three hours at 30 degrees and am getting ready to put it back on for another three hours.  I also managed to take a shower; I just stood with my bad leg outside the tub and sort of contorted my body to be able to wash it all.   ::)  Needless to say, I was exhausted when it was over, but hey....at least I'm clean and my hair smells good.  I'm realizing that when I get up and move around a lot, the result is  a lot of pain, so I need to just allow myself to do NOTHING but lie on the couch for at least these first few days.  I feel good, so I get up to do something, then I pay for it in the long run.  So my goal for tomorrow is to actually just rest and to only get up to use the bathroom.  I'm keeping the long term goal on my mind....but like Mike says....baby steps for now. 
2 x 1.2 cm defect of right medial femoral condyle
Microfracture, right knee, October 18, 2004.
MACI using CaReS, same knee, November 30, 2006

Offline kalyjoe

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Re: From start to finish.. CaReS in US...clinical trial..
« Reply #10 on: December 05, 2006, 12:43:56 PM »
Wearing the immoblizer is getting very old.  I'm tired of sleeping on my back.  I'm tired of the heaviness of this thing as well.  I was reading the literature given to me from the company sponsoring this and I don't see where it says it has to be worn for the entire four weeks.  But I'm pretty sure my OS told me to.  I'm going to call him today and ask if I can at least remove it while sleeping.  I know....I'm whining...and it hasn't even been a week.   ::)

My knee continues to improve.  I have good ROM with little pain or stiffness  and am anxious to take the bandages off to see how much further it can bend.  I'm using the CPM for six hours a  day, split up into 2-3 hour shifts, and although I'm a bit sore afterwards, it's really not bad at all.  Like I said before, it almost provides a bit of relief because keeping my leg in one position all the time is really uncomfortable. 

I'm getting antsy and anxious to drive and get out of the house.  I'm going to try to make it until next week and then have my friends pick me up so I can at least do upper body at the gym.  I'm feeling a bit stir crazy sitting on the couch constantly.  I'm not a patient person, so this is challenging for me.  But, like I said.....if it works it will be well worth it.  (And it BETTER work :-\)

Kristi
2 x 1.2 cm defect of right medial femoral condyle
Microfracture, right knee, October 18, 2004.
MACI using CaReS, same knee, November 30, 2006

Offline Jakem

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Re: From start to finish.. CaReS in US...clinical trial..
« Reply #11 on: December 05, 2006, 04:35:50 PM »
Krisiti,

Most experts will tell you that you need to stay in the knee bace "until you can control a SLR with ease".  The usually takes about 4 weeks.  So when you can do SLRs pretty good, you will be able to ditch the brace.

What is your CPM set at now, still 30 or are you increasing?  Also did you have both clondlye and trochlea defects repaired?

Offline kalyjoe

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Re: From start to finish.. CaReS in US...clinical trial..
« Reply #12 on: December 05, 2006, 04:48:46 PM »
I had an 8mm lesion on the medial femoral condyle.  As far as SLR go, I can do them with a lot of stability, but your statement just motivates me to get even better.   ;D  Haven't heard back from OS yet, but I'm thinking that I'll keep the brace off while I'm lying here and then put it on when I'm up and about or out of the house at least until I hear from him.  It's snowing here now, so it's not like I'll be leaving the house anytiime soon.   ::)

My CPM is set at 30 for days 1-21, then I go to 60 for days 22-30. 

Thanks for the reply!

Kristi
2 x 1.2 cm defect of right medial femoral condyle
Microfracture, right knee, October 18, 2004.
MACI using CaReS, same knee, November 30, 2006

Offline kalyjoe

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Re: From start to finish.. CaReS in US...clinical trial..
« Reply #13 on: December 07, 2006, 07:09:24 PM »
I feel like a new woman!!!  I took a full shower today finally.  ;D I wasn't allowed to get my incision wet for a week, so I've really been suffering.  I have a stool in my shower that I can sit on then slide my legs in.  I sort of balance on one leg while I shower and sit down to pivot back out.  I feel so good now though.  I took all my bandages off and my knee looks surprisingly well.  Only a tiny bit of swelling and my ROM continues to improve.  I'm still doing the CPM which gets old very fast and have really cut back on the pain pills.  I even slept in my bed last night!  (I've been on the couch all week b/c I always fear my husband will kick my knee.  Plus, it was easier with the ice therapy unit.)  I'm not using the ice therapy unit anymore either and I almost feel human again. Just getting all that stuff off my knee makes such a big difference.  I still have to wear the immobilizer when I'm not in the CPM though.  I really do hate that thing.   >:(

 I'm going crazy since I have not even stepped outside in a week, but my daughter's Christmas program is tonight at the school so I'm looking forward to that.  It's so sad that this has become my big night out!!!  It's snowing a lot here now though, so I'm a bit anxious about crutching in that.  All I would need is to fall.  We have a wheelchair that I may use just b/c I think it would be easier and safer. 

I go back to OS next Thursday for a followup visit so we'll see what he says about PT and the immobilizer.

Kristi
2 x 1.2 cm defect of right medial femoral condyle
Microfracture, right knee, October 18, 2004.
MACI using CaReS, same knee, November 30, 2006

Offline gammyknee

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Re: From start to finish.. CaReS in US...clinical trial..
« Reply #14 on: December 07, 2006, 08:55:01 PM »
Hi Kristi

Sorry I haven't posted before now - problem with our internet connection. Things sound pretty good from your end. I can completely relate to the pain of your leg just hanging down with the brace on it - agony. I also completely agree with you about the immobilizer - I have a CaReS rehab protocol which says I'll have to wear it for at least 9 weeks and probably the whole 12 week rehab programme but you seem to be moving along a bit quicker than me so perhaps the same is true of the immobilizer.

I'm now 3 weeks post-op - no pain at site of implant, dressing off my incision and my OS did a fantastic job of the scar, some tightness and stiffness in knee rather than pain and if my leg is down for a long period of time it starts to get a dull ache. One of the main issues is that my leg has been weak since my last surgery in May and having not put weight on it since the implantation, my quad muscle has visibly wasted and this worries me for the long term. Another issue which also seems to get to you is the fact that I need to rely on people to do every little thing (although I am getting more resourceful and doing more) and not being able to get about.

Glad everything seems to be going relatively well. Take care.















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