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 affects 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 an internal problem of faulty foot mechanics due to having misaligned feet.
These include, but are not limited to:
Sprained Ankle Syndrome
This is 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
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, 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 decreases, 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 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
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-tissues reactions. These are self-resolving conditions.