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BY
THE JOURNAL
OF
BONE
AND JOINT
SURGERY, INCORPORATED
Intermediate and Long-Term Outcomes of
Total Ankle Arthroplasty and Ankle Arthrodesis
A Systematic Review of the Literature
By S.L. Haddad, MD, J.C. Coetzee, MD, R. Estok, RN, BSN, K. Fahrbach, PhD,
D. Banel, BA, and L. Nalysnyk, MD, MPH
Investigation performed at Illinois Bone and Joint Institute, Glenview, Illinois, and United BioSource Corporation, Medford, Massachusetts
Background: The efficacy of total ankle replacement compared with that of ankle fusion continues to be one of the
most debated topics in foot and ankle surgery. The purpose of this study was to determine whether there are sufficient objective cumulative data in the literature to compare the two procedures. A systematic review of the literature
addressing the intermediate and long-term outcomes of interest in total ankle arthroplasty and ankle arthrodesis
was performed.
Methods: A comprehensive search of MEDLINE for all relevant articles published in English from January 1, 1990, to
March 2005 was conducted. Additionally, relevant abstracts from the 2003 and 2004 annual proceedings of major
orthopaedic meetings were eligible. Two reviewers evaluated each study to determine whether it was eligible for inclusion and collected the data of interest. Meta-analytic pooling of group results across studies was performed for the
two procedures. The analysis of the outcomes focused on second-generation ankle implants.
Results: The systematic review identified forty-nine primary studies, ten of which evaluated total ankle arthroplasty
in a total of 852 patients and thirty-nine of which evaluated ankle arthrodesis in a total of 1262 patients. The mean
AOFAS (American Orthopaedic Foot and Ankle Society) Ankle-Hindfoot Scale score was 78.2 points (95% confidence
interval, 71.9 to 84.5) for the patients treated with total ankle arthroplasty and 75.6 points (95% confidence interval,
71.6 to 79.6) for those treated with arthrodesis. Meta-analytic mean results showed 38% of the patients treated with
total ankle arthroplasty had an excellent result, 30.5% had a good result, 5.5% had a fair result, and 24% had a poor
result. In the arthrodesis group, the corresponding values were 31%, 37%, 13%, and 13%. The five-year implant survival rate was 78% (95% confidence interval, 69.0% to 87.6%) and the ten-year survival rate was 77% (95% confidence interval, 63.3% to 90.8%). The revision rate following total ankle arthroplasty was 7% (95% confidence
interval, 3.5% to 10.9%) with the primary reason for the revisions being loosening and/or subsidence (28%). The revision rate following ankle arthrodesis was 9% (95% confidence interval, 5.5% to 11.6%), with the main reason for the
revisions being nonunion (65%). One percent of the patients who had undergone total ankle arthroplasty required a
below-the-knee amputation compared with 5% in the ankle arthrodesis group.
Conclusions: On the basis of these findings, the intermediate outcome of total ankle arthroplasty appears to be similar
to that of ankle arthrodesis; however, data were sparse. Comparative studies are needed to strengthen this conclusion.
Level of Evidence: Therapeutic Level IV. See Instructions to Authors for a complete description of levels of evidence.
Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or
grants in excess of $10,000 from DePuy Orthopaedics, a Johnson and Johnson Company. In addition, one or more of the authors or a member of
his or her immediate family received, in any one year, payments or other benefits in excess of $10,000 or a commitment or agreement to provide
such benefits from a commercial entity (DePuy Orthopaedics). No commercial entity paid or directed, or agreed to pay or direct, any benefits to any
research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of
their immediate families, are affiliated or associated.
A video supplement related to the subject of this article has been developed by the American Academy of Orthopaedic Surgeons and JBJS
and is available for viewing in the video library of the JBJS website, www.jbjs.org. To obtain a copy of the video, contact the AAOS at 800626-6726 or go to their website, www.aaos.org and click on Educational Resources Catalog.
J Bone Joint Surg Am. 2007;89:1899-905 • doi:10.2106/JBJS.F.01149
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T
he development of total ankle implants began in the
1970s as an alternative to ankle arthrodesis. Firstgeneration cemented total ankle implants, constrained
and unconstrained, often failed, primarily as a result of poor
implant design, loosening, and instability1,2. Despite these results, the search for a successful ankle prosthesis continued,
leading to the development of a second generation of total
ankle implants with numerous modifications, including a
semiconstrained cementless design, and mobile and fixedbearing designs1,3,4.
The relative benefits of total ankle arthroplasty and ankle fusion continue to be one of the most debated topics in
foot and ankle surgery. Proponents for each procedure advocate their point of view very strongly, but most of the information is anecdotal and based on personal experience. The
purpose of this study was to determine whether there are sufficient objective cumulative data in the literature to compare
the two procedures.
We performed a systematic review of the literature addressing the intermediate and long-term outcomes of total ankle arthroplasty and ankle arthrodesis in terms of ankle
function, pain, revision, conversion to arthrodesis, implant
survival, and quality of life.
Materials and Methods
tandard systematic review methods were used5,6. Initially, a
prospective protocol was written to describe the objectives,
search criteria, study selection criteria, data elements of interest, and plans for analysis. According to the protocol, a broad
search of the English-language literature spanning fifteen
years, from January 1, 1990, to March 24, 2005, was conducted. MEDLINE was searched through PubMed with use of
the following search strategies: (1) “ankle replacement” OR
“ankle prosthesis” or “ankle fusion”; (2) (arthroplasty, replacement [MeSH] AND “ankle”) OR (Arthrodesis [MeSH]
AND “ankle”); (3) 1 OR 2.
A manual reference check of all accepted papers and recent reviews was performed to supplement the electronic
searches and to identify any additional potentially relevant
studies. In addition to the published literature, abstracts from
the 2003 and 2004 annual proceedings of the American Academy of Orthopaedic Surgeons (AAOS) and American Orthopaedic Foot and Ankle Society (AOFAS) meetings were
searched for eligible studies. Eligibility requirements were the
same for abstracts and full publications.
For a study to satisfy the criteria for inclusion, the authors had to have reported on (1) total ankle arthroplasty or
tibiotalar ankle arthrodesis surgery, (2) outcomes of interest at
two years or more after the operation, and (3) at least ten patients in the treatment group. Studies in which all patients had
been treated with only revision total ankle arthroplasty or revision arthrodesis were excluded. There were two reviewers,
who had to agree on all accepted and rejected studies. All
study designs were eligible, including randomized controlled
trials, prospective and retrospective nonrandomized controlled trials, and uncontrolled case series. Multiple publica-
S
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tions on the same patient population were pooled as one study
(kinship) to the extent possible to avoid double-counting of
patients. Protocol-defined data elements from each eligible
study were extracted by one researcher onto a data-extraction
form and were confirmed by a second researcher, who checked
all extracted data against the original report. Differences were
resolved prior to data entry.
Statistical Methods
Outcomes of interest included patient-reported outcome
scores, mobility, function, pain, revision or conversion to an
arthrodesis, implant survival, and prosthetic loosening. In addition, the overall postoperative outcome, based on the patient’s assessment, was recorded. Study, patient, and treatment
characteristics were summarized with use of basic descriptive
statistics. The number of patients enrolled (or randomized)
was used as a denominator in the analysis of baseline patient
characteristics in the assessment of patient-reported efficacy
outcomes. The number of ankles evaluated was used as the
denominator in the analyses of all other efficacy outcomes.
Follow-up scores on the AOFAS Ankle-Hindfoot Scale and on
other scales evaluating ankle pain, function, alignment, and
range of motion were summarized for both total ankle arthroplasty and ankle arthrodesis. Similarly, overall patient outcomes were summarized with use of four categories: excellent,
good, fair, and poor. The definitions of these four categories
were for the most part uniform across studies. The AOFAS
Scale (with excellent defined as 90 to 100 points; good, as 75 to
89 points; fair, as 50 to 74 points; and poor, as <50 points) was
the most commonly used rating system in the studies of total
ankle arthroplasties. The Mazur Score (with excellent defined
as 80 to 90 points; good, as 70 to 79 points; fair, as 60 to 69
points; and poor, as <60 points) was most commonly used in
the studies of arthrodeses. In order to include all available
data, overall outcomes were also categorized as good (including excellent and good results) and poor (including fair and
poor results).
Data were summarized in two ways. First, raw means
and counts were weighted by sample size and calculated for all
outcomes. Second, selected efficacy outcomes were synthesized with random-effects meta-analytic pooling of group results across studies7,8. In random-effects meta-analyses, study
results are weighted by a combination of study size and between-study variation. When there was no variation across
study results that would not be expected due to random
chance, the weighted results were equivalent to those found by
weighting by study sample size. The presence of variation
across study results suggests that important study-level factors
were impacting results, causing large studies to be given somewhat less weight and, concomitantly, smaller studies to be
given somewhat more weight. We report the efficacy results
associated with second-generation implants, including the
Agility and New Jersey LCS (DePuy, Warsaw Indiana),
Buechel-Pappas (Endotec, South Orange, New Jersey), TNK
(Kyocera, Kyoto, Japan), STAR (Waldemar Link, Hamburg,
Germany), and Salto (Tornier, Montbonnot, France) prosthe-
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ses. Similar efficacy outcomes were analyzed, with use of the
same meta-analytic techniques, in the review of the ankle arthrodesis studies. No formal comparison of efficacy or safety
outcomes between total ankle arthroplasty and ankle arthrodesis was performed.
All calculations were performed with use of SAS software (version 8.1; Cary, North Carolina) and SPSS software
(version 14.0; Chicago, Illinois).
Results
Studies
he initial search yielded 460 citations, of which 167 were
retrieved for further review. Sixty-two full publications
and five meeting abstracts met all eligibility criteria for inclusion into the database (see Appendix). Eighteen of these were
identified as kinship studies. The final database included
forty-nine primary studies spanning the years 1990 to 2005.
The studies included fifty-six treatment arms and 2114 patients. Study attrition is shown in Figure 1. The characteristics
of the accepted studies are further detailed in Table I.
T
I N T E R M E D I A T E A N D L O N G -TE R M O U T C O M E S O F
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Of the forty-nine studies, ten (20%) focused on total
ankle arthroplasty and thirty-nine (80%) described ankle arthrodesis; 852 patients underwent total ankle arthroplasty
and 1262 underwent arthrodesis. The majority of the arthrodesis studies (56%) were published between 1990 and 1997,
whereas all ten of the total ankle arthroplasty studies were
published more recently, between 1998 and 2005. The vast
majority of studies were from single centers in the United
States and Europe. Other geographic locations included Japan and Taiwan.
There were no studies directly comparing total ankle
arthroplasty and arthrodesis. Three non-randomized controlled trials of ankle arthrodesis compared different surgical
techniques for arthrodesis. The duration of follow-up
ranged from two to nine years in the studies of total ankle arthroplasty and from two to twenty-three years in the studies
of arthrodesis. The average follow-up time following the total ankle arthroplasties and the arthrodeses was approximately five years.
All ten studies of total ankle arthroplasty (including a
Fig. 1
Study attrition diagram. This algorithm outlines the filtration of studies from inception to conclusion of the
project. Note the substantial number of studies that were rejected on the basis of rigid exclusion criteria.
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TABLE I Study Characteristics
Total
Total
Total Ankle Arthroplasty
No. of
Studies
No. of
Treatment
Groups
No. of
Patients
49
56
2114
Ankle Arthrodesis
No. of
Studies
No. of
Treatment
Groups
No. of
Patients
No. of
Studies
No. of
Treatment
Groups
No. of
Patients
10
12
852
39
44
1262
Publication year
1990-1997
22
26
644
—
—
—
22
26
644
1998-2005
27
30
1470
10
12
852
17
18
618
Publication type
Abstract
Full paper
2
2
123
2
2
123
—
—
—
47
54
1991
8
10
729
39
44
1262
Geographic location
North America
22
27
854
3
4
236
19
23
618
Europe
22
23
1073
6
7
590
16
16
483
Other*
5
6
187
1
1
26
4
5
161
44
50
1771
7
8
569
37
42
1202
5
6
343
3
4
283
2
2
60
42
48
1607
5
6
377
37
42
1230
7
8
507
5
6
475
2
2
32
3
6
121
—
—
—
3
6
121
46
50
1993
10
12
852
36
38
1141
5.32
(1.90-23.00)‡
41
1192
Setting
Single center
Multicenter
Study type
Retrospective
Prospective
Study design
Non-randomized
controlled trial
Uncontrolled
study
Implant
manufacturer†
DePuy Agility
1
1
126
DePuy LCS
1
1
38
Endotec
Buechel-Pappas
2
2
72
Kyocera TNK
1
1
26
Waldemar Link
STAR
4
5
394
Tornier Salto
1
1
96
Mixed (Wright/
Waldemar Link)
1
1
100
Cemented
1
1
26
Uncemented
6
7
654
4.70
(2.30-9.00)‡
7
636
Implant fixation
Follow-up time
5.10
(1.90-23.00)‡
48
1828
*Other includes Japan and Taiwan. †Two implant types were reported in one study (Buechel et al., 2002). ‡The values are given as the
mean and range in years.
total of 852 patients) focused on second-generation total ankle implants. Information on the implants and the methods of
fixation used in the total ankle arthroplasties is also displayed
in Table I.
Patients
Patient characteristics were minimally described in the studies. In those in which the age of the patient population was reported, the mean overall age was fifty-three years (mean
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TABLE II Efficacy Outcomes: Scores and Range of Motion
Total Ankle Arthroplasty
Outcome
Measure
No. of
Treatment
Groups
No. of
Patients
Reporting
Outcome
Mean
5
243
80.6 points
Ankle Arthrodesis
Mean
Meta-Analysis
Mean (95%
Confidence
Interval)
136
75.15
points
75.6 (71.679.6) points
No. of
Treatment
Groups
No. of
Patients
Reporting
Outcome
78.2 (71.984.5) points*
3
Meta-Analysis
Mean (95%
Confidence
Interval)
AOFAS Ankle-Hindfoot
Scale score
Total
Pain
4
354
34.5 points
—
—
—
—
—
Function
4
354
37.4 points
—
—
—
—
—
Alignment
2
85
9.4 points
—
—
—
—
—
Kofoed score
Pain
2
21
50.0 points
—
1
28
32.5 points
—
Function
2
21
21.0 points
—
1
28
15.7 points
—
Mazur score
—
—
—
—
4
86
73.0 points
—
Overall
5
296
26.75°
—
—
—
—
—
Plantar flexion
2
115
15.23°
12.8°
(5.1°-20.5°)*
2
74
16.5°
16.8°
(10.9°-22.7°)†
Dorsiflexion
2
115
11.25°
9.9°
(5.6°-14.2°)*
2
74
0.8°
0.1°
(−7.9°-8.2°)*
Range of motion
*Significant heterogeneity (p < 0.01). †Significant heterogeneity (p < 0.10).
range, eighteen to sixty-four years) (see Appendix). The patients treated with total ankle arthroplasty were older (mean
age, fifty-eight years; mean range, forty-six to sixty-four years)
than those treated with ankle arthrodesis (mean age, fifty
years; mean range, eighteen to sixty-three years) and were predominately female (59%). The majority of the patients in the
arthrodesis studies were male (52%). Rheumatoid arthritis
was the primary indication for the total ankle arthroplasties
(39%), whereas posttraumatic arthritis was the primary indication for the arthrodeses (57%).
Efficacy Outcomes
The reporting of efficacy outcomes was highly variable in
both the total ankle arthroplasty and the ankle arthrodesis
studies; therefore, the analyses performed in the present
study were limited. The AOFAS Ankle-Hindfoot Scale total
score and pain, function, and alignment subscores; the Kofoed scores for pain and function; and the range of motion
(overall and plantar flexion-dorsiflexion) were among the
most frequently reported evaluation methodologies. Table II
presents both the raw means for these outcomes and the
pooled meta-analytic results for the AOFAS total score and
the range-of-motion outcomes for both total ankle arthroplasty and ankle arthrodesis. The meta-analysis mean AOFAS score was 78.2 points (95% confidence interval, 71.9 to
84.5) for the group treated with total ankle arthroplasty and
75.6 points (95% confidence interval, 71.6 to 79.6) for the
group treated with ankle arthrodesis. The raw mean scores
on the individual AOFAS subscales for pain, function, and
alignment were 34.5, 37.4, and 9.4 points, respectively, in the
group treated with total ankle arthroplasty. In the arthrodesis group, the raw mean Kofoed scores for pain and function
were 32.5 and 15.7 points, respectively. Because of the lack of
reporting of variances, meta-analysis of the subscale scores
was not possible.
In the studies of total ankle arthroplasty in which excellent, good, fair, and poor categories were used as overall outcome measures, the result was excellent in 38% of the patients
(95% confidence interval, 0% to 96.8%), good in 30.5% (95%
confidence interval, 21.0% to 39.9%), fair in 5.5% (95% confidence interval, 0% to 16.9%), and poor in 24% (95% confidence interval, 0% to 72.9%). In the arthrodesis group, the
pooled outcomes were excellent in 31% (95% confidence interval, 19.8% to 41.5%), good in 37% (95% confidence interval, 26.4% to 47.3%), fair in 13% (95% confidence interval,
6.2% to 20.3%), and poor in 13% (95% confidence interval,
7.6% to 18.7%).
The authors of several studies used different categorizations of overall patient outcomes (e.g., good-to-excellent results); therefore, in order to include these studies in the
analysis, outcomes were combined into two wider categories:
good (including both excellent and good results) and poor
(including both fair and poor results). The meta-analysis of
this binary outcome (Table III) showed that, in the studies of
total ankle arthroplasty, 78% (95% confidence interval, 61.9%
to 95.0%) of the patients had a good result and 22% (95%
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TABLE III Efficacy Outcomes: Overall Postoperative Outcome Based on Patient Assessment
Total Ankle Arthroplasty
No. of
Treatment
Groups
No. of Patients with
Outcome/Total
No. of Patients
Reporting Outcome
% of
Patients
Ankle Arthrodesis
Meta-Analysis
Mean (95%
Confidence
Interval) (%)
No. of
Treatment
Groups
No. of Patients with
Outcome/Total
No. of Patients
Reporting Outcome
% of
Patients
Meta-Analysis
Mean (95%
Confidence
Interval) (%)
Overall outcome
Excellent
2
48/92
52.2
38.0
(0.0-96.8)*
17
177/508
34.8
30.7
(19.8-41.5)*
Good
2
28/92
30.4
30.5
(21.0-39.9)
17
187/508
36.8
36.9
(26.4-47.3)*
Fair
2
4/92
4.3
5.5
(0.0-16.9)†
17
72/508
14.2
13.3
(6.2-20.3)*
Poor
2
12/92
13.0
24.0
(0.0-72.9)*
17
72/508
14.2
13.2
(7.6-18.7)*
Overall outcome—binary
Good (excellent and good)
6
388/482
80.5
78.4
(61.9-95.0)*
19
427/576
74.1
72.6
(61.2-84.1)*
Poor (fair
and poor)
6
94/482
19.5
21.8
(4.9-38.6)*
19
149/576
25.9
27.4
(16.0-38.8)*
*Significant heterogeneity (p < 0.01). †Significant heterogeneity (p < 0.10).
confidence interval, 4.9% to 38.6%) had a poor result. In the
arthrodesis studies, 73% (95% confidence interval, 61.2% to
84.1%) had a good result and 27% (95% confidence interval,
16.0% to 38.8%) had a poor result.
Data on implant survival, revisions, conversions to arthrodesis, and other clinical outcomes after the total ankle arthroplasties and ankle arthrodeses are presented in the
Appendix. The five-year and ten-year implant survival rates
following total ankle arthroplasty were 78% (95% confidence
interval, 69.0% to 87.6%) and 77% (95% confidence interval,
63.3% to 90.8%), respectively. A revision during the follow-up
period was required in 7% (95% confidence interval, 3.5% to
10.9%) of the patients who had undergone a total ankle arthroplasty. The most common reason for revision was loosening and/or subsidence (28%). Five percent (95% confidence
interval, 2.0% to 7.8%) of the total ankle arthroplasties were
converted to arthrodeses, with the main reason for conversion
being loosening and/or subsidence (50% of all conversions).
Below-the-knee amputation was performed in 1% of the patients treated with total ankle arthroplasty.
Nonunion was observed in 10% (95% confidence interval, 7.4% to 12.1%) of the patients treated with ankle arthrodesis. Nine percent (95% confidence interval, 5.5% to
11.6%) of the arthrodesis group underwent revision, primarily because of nonunion (the indication for 65% of all revisions of arthrodeses). Five percent of the patients treated
with ankle arthrodesis underwent a below-the-knee amputation. Significant heterogeneity was detected in almost all of
these meta-analyses; therefore, the results must be interpreted with caution.
Discussion
o our knowledge, this is the first systematic review of the
intermediate and long-term outcomes of total ankle arthroplasty and ankle arthrodesis. Baseline differences in the
patient populations and the small number of studies contributing to each analysis do not permit formal comparison
between the two surgical procedures. However, the intermediate and long-term outcomes analyzed in this review do
suggest that total ankle arthroplasty is comparable with ankle arthrodesis.
The strengths of this review include the clear definition
of the research question to eliminate bias in the selection of
the studies, adherence to an explicit research protocol that was
developed prior to the analysis, the comprehensive nature of
the literature search (with use of both electronic databases and
manual bibliography searches), consensus between the two reviewers with regard to all data elements prior to entry into the
database, and a quality-control review of all results. However,
despite the strengths of the review process, they cannot overcome the inherent weaknesses in the literature.
The primary limitation of this review is that a direct
comparative meta-analysis of total ankle arthroplasty and arthrodesis was not possible because there were no head-to-head trials. We were only able to perform a pooled meta-analysis
across all studies, with many studies being devoid of key data
elements, including methodology reporting and baseline patient information. In addition, the variability of the reporting of outcomes of interest limited the number of studies for
each meta-analysis. In fact, differences in patient populations,
variability of surgical procedures, and differences in outcome
T
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evaluation tools and study follow-up times may all be partially
responsible for heterogeneity among these studies. In future
studies, it will be important to use uniform evaluation tools to
make comparisons easier.
This study exposed the major lack of objective, prospective, and controlled data on either procedure. The findings of this review demonstrate that the available data on
the results of these procedures are based predominantly on
retrospective uncontrolled case series from single institutions. The sample sizes in many of the studies were small.
Therefore, prospective studies are needed to compare the
two procedures in similar patient groups.
Despite these limitations, this study provides evidence that both procedures yield satisfactory results, and
the data suggest equivalence between the procedures, negating the poor connotations associated with ankle arthroplasty due to failures associated with first-generation
implants. In fact, while all patients may not be candidates
for ankle arthroplasty, it should be considered as a treatment option for those with ankle arthritis, with the clinician being allowed the latitude to determine appropriate
indications.
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Appendix
Tables presenting the patient characteristics and the clinical outcomes from the combined studies as well as a list
of the studies that were evaluated are available with the electronic versions of this article, on our web site at jbjs.org (go to
the article citation and click on “Supplementary Material”)
and on our quarterly CD-ROM (call our subscription department, at 781-449-9780, to order the CD-ROM). „
S.L. Haddad, MD
Illinois Bone and Joint Institute, Glenview Medical Arts Building,
2401 Ravine Way, 2nd Floor, Glenview, IL 60025. E-mail address:
slhaddad@earthlink.net
J.C. Coetzee, MD
Orthopaedic Clinic, Riverside Campus, 1st Floor, R102, 2512 South 7th
Street, Minneapolis, MN 55454
R. Estok, RN, BSN
K. Fahrbach, PhD
D. Banel, BA
L. Nalysnyk, MD, MPH
United BioSource Corporation, 101 Station Landing, Medford, MA 02155
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