Foot & Ankle International - June 2017 - 663

Raikin et al
70% loss of hindfoot mobility. He also noted progression of
hindfoot degenerative changes after tibiotalar fusion.22
In an effort to preserve normal joint biomechanics,
ankle replacement systems were introduced in the 1970s.
Although early results were promising, studies looking at 5
to 10 years' follow-up showed an unacceptably high rate of
failure. Patient satisfaction was reported to be between
10% and 65%, leading Kitaoka and others to state that
ankle replacement was a "procedure that should not be
performed."2,8,17,35,37 These early failures were the impetus
for improved instrumentation, less bone resection, more
attention paid to the surrounding soft tissues, and improved
implant designs, resulting in improved survivorship and
long-term patient satisfaction.11,13
The Agility Total Ankle (DePuy, Warsaw, IN) represented the first of the second generation of ankle arthroplasty to be Food and Drug Administration approved in the
United States in 1999. The Agility system is a semiconstrained system, which is generally implanted uncemented,
designed through analysis of computed tomographic (CT)
scans of normal ankles. Bone resection was minimized and
the syndesmosis fused to increase the surface area for the
tibial tray and limit subsidence. Published studies of the
designer's patients showed an encouraging 87% survival at
9 years' follow-up; however, a meta-analysis by Roukis
et al reported that if these patients were excluded, revision
rates in other studies were double that of the designers.31
Previous studies have looked at midterm follow-up reporting high levels of implant survivorship and patient satisfaction albeit with associated complications of implant
subsidence, osteolysis, implant loosening, and syndesmotic
nonunion.5,18,20 Five-year survival rates were reported as
78%, with 8- to 10-year survival of only 56% to 61%.7,21,34
As a result, the Agility system fell out of popular use, and
has been replaced by newer third-generation systems.
The Agility system, however, has the longest follow-up
of ankle arthroplasties in the United States and offers potential insights into the potential performance of the newer systems. We report on the clinical and radiographic outcomes
in our cohort of 127 Agility total ankle replacements (TARs)
at a mean follow-up of 9.1 years.

Methods
After obtaining institutional review board approval, we retrospectively identified all patients who underwent TAR
using the Agility TAR system. After conducting a review of
the electronic medical records, 127 total patients were identified. All surgeries were conducted by a single fellowshiptrained surgeon, with no relationship to the designer or the
company, in a tertiary care setting. All patients were called
to return for clinical and radiographic follow-up using the
standard postoperative evaluation for patients undergoing
TAR. Only patients available for direct evaluation were
included in the study. Patients undergoing removal of their

663
Table 1. Patient Demographics.
Demographic
Number
Age
Gender
Male
Female
BMI
Diagnosis
(posttraumatic/
atraumatic/
inflammatory)
Diabetes
Yes
No
Steroid use
Yes
No
Tobacco
Yes
No

Survived

Failed

90
66.2 (42-83)

25
60.3 (36-74)

48
42
28.3 (18-38.3)
63:25:2

13
12
29.4 (19.5-39-3)
9:11:5

P Value
NA
.0094
1

.27
.001

1
8
82

2
23

4
84

4
21

7
83

1
24

.07

1

Abbreviations: BMI, body mass index; NA, not applicable.

TAR and revision or fusion had their outcome scores at the
time of their failure (prior to removal) included in the results
of the study.
A total of 127 patients underwent TAR with the Agility
Total Ankle by the senior author (S.M.R.) between 2002
and 2009. Twelve patients (9.4%) were lost to follow-up.
Patient demographics are listed in Table 1 for the remaining
115 patients (90.6% follow-up). Average age at time of surgery was 64.9 years old (range 36-83 years), with an average body mass index (BMI) of 28.5 (range 18-39).
Underlying cause of the arthritis for which the TAR was
performed was posttraumatic in 72 patients (62.6%), primary degenerative in 36 patients (31.3%), and inflammatory arthritis in 7 patients (6.1%). There were 58% male and
42% female patients. Exclusion criteria for TAR were talar
osteonecrosis, prior ankle septic arthritis/osteomyelitis, diabetic neuroarthropathy, and severe peripheral vascular disease. The senior author, however, used discretionary
selection criteria for his patients undergoing TAR, typically
avoiding patients with BMI >35, patients younger than 50,
cigarette smokers, diabetics with neuropathy, or patients
considered high risk for TAR. These selection criteria may
have influenced some of the results and reported risk factors
for failure demonstrated by the results of this study. The
average duration of follow-up for the 115 patients was 9.1
years (range 4.1-13.8).

Radiographic Evaluation
As part of their routine follow-up, patients underwent a
5-view weight-bearing series of radiographs (anteroposterior



Table of Contents for the Digital Edition of Foot & Ankle International - June 2017

Contents
Foot & Ankle International - June 2017 - Intro
Foot & Ankle International - June 2017 - Cover1
Foot & Ankle International - June 2017 - Cover2
Foot & Ankle International - June 2017 - i
Foot & Ankle International - June 2017 - ii
Foot & Ankle International - June 2017 - Contents
Foot & Ankle International - June 2017 - iv
Foot & Ankle International - June 2017 - v
Foot & Ankle International - June 2017 - vi
Foot & Ankle International - June 2017 - vii
Foot & Ankle International - June 2017 - viii
Foot & Ankle International - June 2017 - 1A
Foot & Ankle International - June 2017 - 1B
Foot & Ankle International - June 2017 - ix
Foot & Ankle International - June 2017 - x
Foot & Ankle International - June 2017 - xi
Foot & Ankle International - June 2017 - xii
Foot & Ankle International - June 2017 - 2A
Foot & Ankle International - June 2017 - 2B
Foot & Ankle International - June 2017 - xiii
Foot & Ankle International - June 2017 - xiv
Foot & Ankle International - June 2017 - xv
Foot & Ankle International - June 2017 - xvi
Foot & Ankle International - June 2017 - 3A
Foot & Ankle International - June 2017 - 3B
Foot & Ankle International - June 2017 - xvii
Foot & Ankle International - June 2017 - xviii
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Foot & Ankle International - June 2017 - CT1
Foot & Ankle International - June 2017 - CT2
Foot & Ankle International - June 2017 - 4A
Foot & Ankle International - June 2017 - 4B
Foot & Ankle International - June 2017 - Cover3
Foot & Ankle International - June 2017 - Cover4
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