Potential Risks and Complications with Any Surgery
HyProCure is a relatively simple and brief procedure of 20-minutes or less. In the very rare case, the procedure can be reversed with no long-term effects on the patient. As with any surgical procedure, there are potential risks. The slide presentation below illustrates the possible risks and complications of Extra-Osseous Talo Tarsal Stabilization (EOTTS). HyProCure is an effective form of EOTTS and is a minimally invasive procedure to resolve the internal problem of faulty foot mechanics due to having misaligned feet.
These include, but are not limited to:
Sprained Ankle Syndrome
This is a discomfort to the outer ankle ligaments due to a new stretch placed on those ligaments. This should be a temporary symptom and will most likely dissipate. However, it is possible that the ligaments, for whatever reason, are not able to adjust to the new position, leading to several months of discomfort, pain, limitation to walking/standing, and possibly removal of the stent. This is not a problem with HyProCure but of the soft tissues. If the problem does not improve after six to eight months of treatment, including wearing good, supportive shoes, taking anti-inflammatory medication, injections, or bracing, it may be necessary to either downsize or permanently remove HyProCure.
Displacement/migration of the implant
Even though HyProCure is inserted correctly at the time of surgery, it can shift or displace. Every sinus tarsi is different and HyProCure may need to “seek its own position.” The stent is only pushed into the sinus tarsi; it is not drilled or cemented. If displacement of the implant does occur, it almost always will happen within the first four weeks post-op. Although it can displace after the four weeks, this is extremely rare. If slight displacement does occur, the implant is holding correction, and the patient has no pain or discomfort, a revision is not needed. If there is a loss of correction, the implant will have to be repositioned and the patient will have to be careful with the way he/she walks, etc., during the four to six weeks it takes for the tissues to hold the stent in place. It is possible that even with ideal placement surgically, along with optimum patient compliance, the implant will still displace and migrate. This is due to anatomical variations within the sinus tarsi and the inability of the soft tissues to hold the implant in place.
Inability to place HyProCure within the sinus tarsi
This is a rare but possible complication. Even though clinically and radiographically it appears that the patient’s sinus tarsi would accept the implant, it is possible that due to the bone tissue anatomy, the severity of the deformity, and other factors, the stent may not be able to be inserted into the sinus tarsi. Another possibility is that even if the implant is placed within the sinus tarsi, there will be displacement of the implant when the foot is put through the range-of-motion. If the implant will not hold correction intra-op, it should not be left within the sinus tarsi in the hope that it will hold post-op. The implant should be removed and the patient will need to have some other form of surgical intervention.
Possibility of under- or over-correction
There are six different HyProCure sizes and one of these sizes should fit nearly every potential candidate. However, more than one size may seem to fit. It is possible that one size gives not enough correction and the next size gives too much. It is always better to have an “under-correction” than an “over-correction.” Trial sizing is done while the patient is off of their feet so there could be a difference once the patient stands. Initially, after the procedure, the correction will seem to be higher due to swelling and inflammation around the surgical site. Once the swelling and inflammation decrease, it may appear that there was a loss of correction, however, this is the true correction the surgeon wanted to achieve. It could also be due to a ligamentous or tendon laxity when, after several months, there is a loss of correction. In this instance, other additional surgical procedures may need to be performed.
Even though HyProCure is placed where it should be, it is possible that, due to the very complicated foot structure, there are other deformities that need to also be addressed. This is not a failure of HyProCure to stabilize the ankle bone on the heel bone.
Prolonged pain and period of swelling and abnormal walking or standing
Every person has a different pain tolerance. The patient should expect to have a period of pain and tenderness after this procedure, especially during the first few months. After three to six months, there might only be a rare, quick, stabbing pain, but pain should not be present consistently. If after 6 months there is no improvement, it is possible that the tissues just won’t adapt and that the implant will need to be removed. Follow the steps indicated by your doctor to ensure you are not making the situation worse.
It is a widely accepted practice that even when there are no risk factors, it is prudent to give a pre-op antibiotic before the HyProCure procedure. High-risk patients should also follow up with a regimen of post-op antibiotic therapy for seven to ten days as indicated. If a serious deep infection does occur following the procedure, the implant should be removed, 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.