Saturday, April 2, 2016

4/2/2016

Well the new titanium rod is in place!  Evan was operated on to remove the cadaver implant and place the new expandable rod on Friday 3/25/2016.  We needed to be at All Children's Hospital by 6:30 AM for admission and Pre-op with an expected surgery time of 8:30.  We left Fort Myers about 4:00 AM and arrived around 6:00 AM.  Evan was understandably nervous as he was well aware of what was about to happen to him.

The pre-op was going fine just as soon as we got the operating gurney out of the room.  Evan did not want to see that at all.  He was cooperative and eventually we gave him a nice cocktail of feel good drugs to get him further in the mood.  His Doctor and Anesthesiologist were both in and the good thing with pain management this time is the Anesthesiologist was able to place the nerve block for as long as necessary instead of just a few hours
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Prior to the commencement of surgery, Meghan was presented with a 7 page document from John Hopkins which All Children's is a part of.  It detailed how the new titanium rod was not FDA approved and the FDA had granted an allowance based on compassionate use.  This is a term the FDA uses when a non approved item would be of a better benefit to a patient even thought it is against the rules.  Evan qualified based on the fact that the other alternative would have been amputation. Stanmore the manufacturer of the device is based in the UK and I believe has been working with the FDA to obtain approval for  device use in the US.  Evan would be the third US approved implantation.  We know of one other patient with the device, her implant was done 3 years ago and involves not only the humerus but a full elbow.  I can tell you that she is doing very well with the device and had the procedure done at All children's with the Moffit team.  There are only 75 total implants done world wide prior to Evan's surgery.

The document went on to describe that the cost of the implant would be determined later and that there may or may not be a fee or co-pay.  The hospital may or may not bill insurance and that she by signing agreed that John Hopkins did not compensate the family in anyway for the device implantation.  The document contained an IRB number which I immediately knew that the device was part of an ongoing study.  The IRB (internal review board) is an independent  group that are advocates for patients and watch over physicians and hospitals when medications or devices or procedures are performed on patients when those items are still not approved by the FDA.  This board requires investigators (hospitals and physician) to regularly report on the device and the patient.   The FDA then reviews how well the device, etc. performed over a set period of time and will approve or disprove based on the performance.  In medications, if the medications caused severe reactions in a large percentage of patients it would not be approved.  In Evan's case, I believe he will be followed for many many years to see if the device performs as expected.  I also think that this is exciting as one of the youngest patients to have the implant will assist in future determination of acceptance by the FDA.  I have experience with the IRB as at my work, my physician has participated in several studies related to eye medications and surgical procedures.

The surgery was expected to take approximately 6 hours and ended up at around 7 hours.  the extra hour was needed to place the catheter for the nerve block so in reality the surgery did take 6 hours.  We were apprised of the progress of the procedure at about 1.5 hour levels.  Eventually we were called back to the conference room for a briefing with the Doctor.  He told us all went extremely well and that Evan had tolerated the surgery and anesthesia as expected.  We discussed how if he was doing well with pain management we could bring him home as early as Sunday with Monday being the most likely day for discharge.  He went over the pictures taken during the procedure and sent me three of them for my collection.  I am amazed at how complex this procedure was and the skill demonstrated by the Doctor.  I believe Evan has a great chance for a successful recovery and a range of motion beyond expectations.  He scar will be minimal and more of a straight line because the stitches are internal and he used Dermabond adhesive to seal the skin together.

Evan's recovery and pain management had its ups and downs but all in all he did very well.  As expected Saturday was very tough with pain management but by Sunday there was a different boy in the bed that was much better and tolerant.  Evan was able to move his hand and wrist almost immediately after surgery and noted a numb thumb sensation.  We expect the numbness to subside as this is a result of manipulation of nerves responsible for hand movement.  We were able to transition off the nerve block Sunday morning and by 6:30 PM we were on our way back home, a very nice Easter present.

Evan will have to have a shoulder immobilizer sling for 6 weeks to keep him from shoulder adduction which is to move the arm away from the body kind of like a chicken wing movement.  The reason for this immobilization is to allow for the muscles and tendons that were either stitched or placed around the new implant time to heal/scar in before movement.  The device was wrapped in a goretex like material to allow muscle to scar onto it.  He is to continue to move his elbow up and down and to move the wrist and flex the fingers.  This brace was designed and put on him early on Monday and he is tolerating the brace well.

Evan has a 2 week post-op appointment in Tampa with the Doctor on Friday 4/8/2016.  I will post on his progress after the visit.