Biomedical Engineering Reference
In-Depth Information
c)
The Agility Total Ankle System
The following articles are examples of the high rate of complications associated
with a semi-constrained device that is cleared by the FDA and legally marketed
throughout the United States.
Saltzman CL et al: Surgeon Training and Complications in Total
Ankle Arthroplasty.
Foot and Ankle Int.
Vol. 24, No. 6, pp.514-518,
June 2003.
There were 26 patients in the study. The study assessed the problems
with the initial use of ankle arthroplasty. 3 Groups were observed;
Group 1 assessed 3 surgeons who were trained observing the
surgeon/inventor; Group 2 assessed 3 surgeons who completed a
structured, hands-on surgical training; Group 3 assessed 3 surgeons
who were trained during a 1-year foot and ankle fellowship. The
combined 3 groups reported 28 Syndesmosis non-unions, 19
Intraoperative complications, 7 Major revisions, 8 Syndesmosis Re-
arthrodeses and 14 other secondary operations. Three Patients
received a below the knee amputation.
The authors admitted that due to the small sample size the study had
clear limitations. However, a relatively high complication rate could
be the result of a 'high learning curve' [48].
Rippstein PF: Clinical experiences with three different designs of ankle
prostheses.
Foot Ankle Clin N Am.
7:817-931, 2002.
A total of 27 ankles were implanted in 25 patients. 19 PTA and 8 RA.
Mean age 56.9 years. Mean follow-up 14.7 months. Eight revisions.
Four seriously migrated. Two removed and ankle fused, one had tibial
replacement, another was asymptomatic and left implanted. One early
deep infection successfully treated. One case of complicated and painful
tibial nerve neuropathy. Three revisions due to bony proliferation on the
resected talus area, which was painfully impinging on the tibial
component during dorsal extension. One Dwyer osteotomy performed as
a result of medial ankle pain due to a varus malposition in the previously
fused subtalar joint.
The author admitted that the high complication rate could be improved
with further surgical experience, yet expressed serious concerns about the
difficulty of performing any future potential fusion [49].
