Dieter - here you go.

Some pearls on the Gramedica Hyprocure device.
1) take the online course
2) go to an in person training seminar
3) now, your ready.
4) pick the appropriate patient (more later)
5) take weight bearing DP and Lateral view. On a lateral view you are looking at a few things:
A) the position of the talus relative to the bi section of the first met.
B) obliteration of the sinus tarsi
C) Cyma line breakage
D) calcaneal inclination angle
The importance of the calcaneal inclination angle is that if it is low and there is a high degree of sagital plane deformity then the person post op will have a higher arch then preop but it will still be low.
Note: it is fallacy that the calcaneal inclination angle doesn't always change in this procedure. It will when the talus is very plantarflexed as the talus is tilting the distal edge of the anterior calcaneus downward and when the talar position is restored it takes pressure off the distal calcaneus and allows it to increase the angle. (Maybe, not alot but significant enough to notice it.)
Dr. Graham recommends you do this (take xrays)in both the relaxed stance as well as "corrected position" or as close to STJ neutral as patient will get into.
(I, only take the relaxed stance)
On the DP view: you are mainly looking at:
A) the talar- second met angle
B) presence of rearfoot valgus and forefoot abductus
C) met adductus (presence of)
6) if when you examine the patient you feel the foot is not going thru range of motion as you would expect, or see on xray possibility of coalition order a CT scan.
(Unfortunately, there are those that own PET scans and abuse this by taking scans on all their patients. What can you do....)
7) patients with coalitions are contraindicated, except fibrous coalitions.
- I have noted that fibrous coalitions are not necessarily rigid and you can break up the fibrous coalition and complete the procedure without issue.
8) Beware of met adductus. One can still do the procedure on these patients but the met adductus will be brought out more and the patient can in toe more. [I have done it on these patients by warning the parents with the caveat the device could always be removed if they were unhappy. Not one chose to remove it.]
9) Equinis: in school one is taught when doing a stj arthroeresis a tendo Achilles lengthening is needed as an adjunctive procedure.
I have this to be fallacy. I have never done one with my hyprocures and it has not been an issue. Dr. Graham teaches if the patient can get to 90 degrees you should be okay. I have found this to be true. One will notice the degree of dorsiflexion of the ankle will actually improve as the joints are aligned more appropriately than they were pre-op.
10) use the hyprocure consent form. (Always make sure when operating you have a good consent)
11) take preop photos of patient weight bearing.....for comparison latter
12) mark the sinus tarsi with a GV pen. I simply place my index finger in the indentation of the sinus tarsi opening and mark a dot on both sides of my index finger, connect the dots and that is my skin incision. Every patient therefore has an identical incision as it is the width of my index finger.
13) always, use local anesthesia. (Even if you are using general, use the local anyway) the reason is fourfold:
1) there is epi in the injection so that no tourniquet is needed.
2) there is dex phosphate in the injection to reduce swelling in the sinus tarsi
3) if you use a 25 gauge 1 and a half inch needle, the entire needle should be placed into the sinus tarsi till the hub. By placing it in this far you will already know the angle of the sinus tarsi canal that you need to follow as it is the same path as the needle.
4) since, the procedure is quick, you will have post op anesthesia in the canal which is harder to put into the canal once the implant is in place.
14) before you start, place the foot thru range of motion a few times so that you refresh in your mind what you are trying to correct. I do this with both rearfoot and forefoot. (Though, I maintain the rearfoot range of motion is more important at this point)
15) use Pre op antibiotics of your choice as an implant is being used.
16) once you start, make skin incision and place knife down.
17) poke a hole to start a canal with a pair of dissection scissors. (Either graham decompression scissors or a littler. The tip of the scissors should face posterior.
18) don't be afraid, cut tissue down to sinus tarsi and then all ligamentous structures in the canal. (Review your anatomy, this is safe)
- take scissors out, repeat (invariably, there are more fibers.)
19) place axis guide wire into the canal which should be distal lateral proximal medial. You should feel tenting on the medial side.
Place the lowest size trial in first the number five. Place foot thru range of motion and see if any correction achieved. Look at c-arm to ensure proper placement.
I also use the #5 as a dilator to ensure I made a good canal for the trial sizers and to remove any remaining fibers that the scissors may of missed.
Keep sizing up until you feel you have the correct size.
Always make sure the trial sizer can fit into the canal with c-arm.
Always check that rearfoot range of motion to make sure you don't close down motion altogether. The patient still needs to pronate. (About 3-5 degrees)
Deciding on the correct size is the hardest part of the procedure.
When your trying to decide and your stuck on two sizes, chose the smaller size.
20) once you decided on the size, let the circulator know to hand you the implant in the bag, (try to handle was little as possible). I slide it on the axis guide wire trying not to touch it.
Irrigate the canal before putting in the implant.
21) as you are sliding the implant in with the driver you need to take the axis guide wire out before the final push or you will bend the wire or not get the implant in totally. The implant will not seat itself if you try to finalize its position with that wire still in.
22) once, you drive it in, shake the driver to loosen the implant off it without the implant being taken back out....
23) confirm placement on c-arm, get an xray (for documentation purposes)
24) close. Dr. Graham taught me a running subcuticular baseball stitch that is very good for this anatomical region as it tightens down as the is tension on the skin.
25) post op injection, again, With dec phosphate and local.
26) dressing....lately, I am using cast padding with coflex then apply an ankle brace.
27) I do one week of crutches then the ankle brace in a sneaker for three weeks. Some walk them, some cast them, you do what your comfortable with.

I hope that was informative. The above are based on both Dr. Graham's teaching and modifications based on my experience. I have shared all and hide nothing.
Try it, I think you will like it. Anyone can feel free to ask any questions and I will do my best to answer.
  • Comments (88)
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  • I'll give it a try.  Thanks so much I'll let you know if it works for me.

  • Mike - sorry for the delay : my current settings are KV 50 and .2ms but keep in mind I can correct any error on my digital processor.

  • Mike - I, too have an x-cell. I will look at my settings tomorrow for you. When I got the unit, I think I was told different views had different settings but since I use a CR- developer, I just play with the clarity on the developer to fix any faulty setting on the X-ray unit itself. There are times I recall having some difficulty seeing it as well, but after some adjustments on the developer it comes into view.
    Let you know in the morning.
  • Jeff, 

    I've done another one they are fun to do when they stay in place so far so good. Do you know X-ray settings for the AP, I have a x-cell machine it's older now (like me) works fine.  On the AP I can not see the implant. I used to be able to see it and see how the lateral edge is aligned. I can see the head of the talus and how it is aligned just can't see the implant. Would I need more time, higher MA I think we use 10 MA. The implant is visible on the lateral view.  Any help is appreciated. Thanks 

    Mike

  • Gary - welcome to the blog.
    My children will likely both need braces for their teeth. I have no dental coverage let alone orthodontics coverage.
    The Orthodontist is not going to be sitting there feeling sorry for me. He will tell me the cost and I will proceed or not.
    Not everything is a coveted benefit.
    Your job is to explain how it will help and to chose appropriate patients.
    If they want it they will do it. If they can't afford it you can work out payment plans or use care credit etc.
  • Appreciate the dialogue on HypoCure. My obstacle is all insurance companies deny this procedure placing all costs on the patient.

    Any suggestions are appreciated. Previously, coding advice by many was to use: reduction of dislocation or arthrodesis codes which are not appropriate. 

    My review shows the temporary code (is still): 0335T: Extra-osseous subtalar joint implant for talotarsal stabilization

    Despite FDA approval of the HypoCure the insurance message remains "investigational": I have tried to use the following to make a point usually denied but still lots of work with frustrating results. The following is taken from the  BC BS website

    POLICY EXCEPTIONS: Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

  • Mike - awesome. That is my protocol one week off weight. If you think about it logically if nothing holds the device in the canal then walking immediately has the highest chance of dislodging the implant.
  • Hi Jeff,

    Yes, I have Michael Grahams scissors. Sometimes when I cut the ligament I could not feel it but I sure did this last time.  I kept the last two pts. nonwt. bearing for at least a week which I believe also helps.  Thanks so much for your help.

    Mike

  • Jeff,

    I ran into one the Forest Hill 2nd year residents, rotating through our office, last Friday - he knows you. I asked him to say 'hello' next time he's in the OR with you.  

  • Mike - your very welcome, happy to hear. My hats off to you for your resilence in not giving up and trying the procedure again. Many May of decided to no longer do a procedure that didn't work out for them.
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