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Potential complications

Even though this is a relatively simple, short, and fully reversible procedure, potential complications, as with any surgical procedure, could occur, including but not limited to:

"Sprained Ankle Syndrome"
This is discomfort to the outer ankle ligaments in front of the lateral malleolus. This should be a temporary symptom and will most likely dissipate. If it seems that this problem is not resolving on its own, follow these guidelines. First, make sure the patient is wearing good supportive shoes and that the outer heel is not worn. Second, make sure the patient is taking an anti-inflammatory medication and icing the outer ankle a few times a day, especially at night prior to going to bed. If this doesn’t bring any relief, then a superficial steroid injection of 1.5 ccs of 0.05% marcaine mixed with either a short- or long-term steroid (0.5 cc to 0.75 cc) in the superficial lateral gutter. A maximum of three injections may be given. If after the third injection, and with the patient being compliant on shoe-gear, anti-inflammatory meds, and icing, the discomfort is still present, it could be that they are just not going to tolerate the size of the device chosen, and will will have to have a revision to a smaller size or permanent removal of HyProCure.

Displacement / migration of the implant
Even though the HyProCure stent is inserted correctly at the time of surgery, it is possible for it to shift or displace. Every sinus tarsi is different and the stent may need to "seek its own" position. The HyProCure device is just inserted into the sinus tarsi—it is not drilled or cemented. If displacement occurs, it will have likely happened within the first 4 weeks post-op. Although it is possible for it to displace after the 4 week period, it is rare. If displacement does occur and the device is not in the most desirable location, we recommend the following guidelines:

Inability to place the HyProCure stent within the sinus tarsi
A rare, but possible complication. Even though clinically, radiographically, etc. it appears that the patient's sinus tarsi would accept a HyProCure implant; it is possible that due to the osseous anatomy, severity of the deformity, etc., a device may not be able to be inserted into the sinus tarsi. Another possibility is that even if a HyProCure was placed within the sinus tarsi, when the foot is put through the range-of-motion it is displaced. If the HyProCure will not hold correction intra-op, it should not be left within the sinus tarsi in the hope that it will hold post-op. It should be removed and the patient will need to have some other form of surgical intervention.

Inability to achieve the desired correction
It is possible that due to the chronic nature of the deformity that the talus has ground down the anterior lip of the calcaneus. The surgeon is able to place the device into the sinus tarsi in the desired location and there appears to be correction on the table, however, when the patient bears weight on the talus, the HyProCure slips off the calcaneus. This complication is hard to determine pre-op.

Over-correction
If the surgeon does not properly re-create the amount of ground reaction force placed on the foot (doesn’t pronate the foot with enough force), then it is possible to use too large a device, and when the patient bears weight there is too much correction resulting in a supinated foot. Keep in mind that during the initial recovery, the patient will supinate their foot when walking, which is due to the guarding mechanism and does not necessarily mean that they have been over-corrected. The trend for novice HyProCure users is to over-size. Please know that the most common HyProCure sizes are size 7, then size 6, size 5, size 8, size 9, and the least used size, 10.

Under-correction
It may appear that you have selected the perfect size HyProCure to achieve the correct amount of pronation on the operating room table, however, upon post-operative follow-up it appears the patient has lost the correction. This could be due to the fact that the patient is non-weightbearing during the procedure and we are trying to re-create the ground reaction forces to the subtalar joint, which we cannot always recreate. We have to do the best to re-create these forces with the patient lying on the operating room table. It is recommended to under-correct than to possibly over-correct and put the patient into a supinated gait. If this under-correction does occur, then a larger size stent can always be inserted. If a situation arises where the size 7 and size 8 look to give about the same correction, it is recommended to downsize and use the 7 than to upsize and use the 8.

Infection
It is a widely accepted practice that even when there are no risk factors, it is better to give at least a pre-op antibiotic before a Talar Tarsal Stabilization procedure. High risk patients should also be followed-up with a regimen of post-op antibiotic therapy for 7 to 10 days as indicated. If a serious deep infection does occur following a Talar Tarsal Stabilization procedure, the implant should be removed and an incision and drainage procedure should be performed and appropriate antibiotic coverage should be initiated. Once the infection is fully resolved, re-implantation can occur.

Synovitis / bursitis / capsulitis
These are various soft tissue inflammatory reactions to the new position of the sinus tarsi. For many patients, the abnormal motion of the talus on the calcaneus has resulted in many different types of disease processes and abnormal soft tissue compensations. Once the sinus tarsi is re-aligned, it is possible to irritate or exacerbate these soft-tissue reactions. Occasionally, a patient will present post-operatively with persistent drainage from the incision. It could be from the synovitis, however, it is not a reaction to the device. Titanium is a very non-reactive material and not prone to rejection. The drainage is usually a result of the accumulation of joint fluid in the lateral envelope and since it can take up to three weeks for the skin to heal, the fluid will leak out of the incision. We recommend the application of topical betadine to the incision once a day, and within a few days there is usually complete resolution of this condition.

Disproportionate pain
As with any surgical procedure, one must be careful to look for the signs of reflex sympathetic dystrophy (RSD) and the cardinal signs of disproportionate pain—swelling, acute sensitivity to touch, joint pain, and color and temperature changes. Many of these symptoms are present during the early stages of recovery, but will resolve with appropriate pain medication and ice therapy. If the symptoms do not resolve with oral medications or ice therapy, keep RSD in the back of your mind.

Need for further surgery
If there is an intolerance of the soft tissues to adjust to the new correction, or if there is displacement/shifting of the implant, further surgery will be necessary.

Other
Complications associated with surgery or the administration of medications or anesthesia.