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Orthopaedics & Traumatology: Surgery & Research 102 (2016) 1029–1034

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Original article

Total hip arthroplasty survival in femoral head avascular necrosis


versus primary hip osteoarthritis: Case-control study with a mean
10-year follow-up after anatomical cementless metal-on-metal
28-mm replacement
D. Ancelin ∗ , N. Reina , E. Cavaignac , S. Delclaux , P. Chiron
Département de Chirurgie Orthopédique, Traumatologique et Réparatrice, Hôpital Pierre-Paul-Riquet, place du Dr-Baylac, TSA 40 031, 31059 Toulouse
cedex 9, France

a r t i c l e i n f o a b s t r a c t

Article history: Background: Total hip arthroplasty is the most widely used procedure to treat avascular necrosis (AVN)
Received 7 February 2016 of the femoral head. Few studies have compared the outcomes of THA in femoral head AVN and primary
Accepted 18 August 2016 hip osteoarthritis. Therefore we performed a case-control study to compare THA for femoral head AVN
vs. primary hip osteoarthritis in terms of: (1) prosthesis survival, (2) complication rates, (3) functional
Keywords: outcomes and radiographic outcomes, (4) and to determine whether specific risk factors for THA failure
Avascular necrosis of femoral head exist in femoral head AVN.
Total hip arthroplasty
Hypothesis: THA survival is similar in femoral head AVN and primary hip osteoarthritis.
Survival analysis
Revision surgery
Material and methods: We compared two prospective cohorts of patients who underwent THA before
Comparative study 65 years of age, one composed of cases with femoral head AVN and the other of controls with primary
hip osteoarthritis. In both cohorts, a cementless metal-on-metal prosthesis with a 28-mm cup and an
anatomical stem was used. Exclusion criteria were THA with other types of prosthesis, posttraumatic AVN,
and secondary osteoarthritis. With ␣ set at 5%, to obtain 80% power, 246 patients were required in all.
Prosthesis survival was assessed based on time to major revision (defined as replacement of at least one
implant fixed to bone) and time to aseptic loosening. The other evaluation criteria were complications,
Postel-Merle d’Aubigné (PMA) score, and the Engh and Agora Radiographic Assessment (ARA) scores for
implant osseointegration.
Results: The study included 282 patients, 149 with AVN and 133 with osteoarthritis. Mean age was
47.8 ± 10.2 years (range, 18.5–65) and mean follow-up was 11.4 ± 2.8 years (range, 4.5–18.3 years).
The 10-year survival rates were similar in the two groups: for major revision, AVN group, 92.5% (95%
confidence interval [95% CI], 90.2–94.8) and osteoarthritis group, 95.3% (95% CI, 92.9–97.7); for asep-
tic loosening, AVN group, 98.6% (95% CI, 97.6–98.6) and osteoarthritis, 99.2% (95% CI, 98.4–100). The
AVN group had higher numbers of revision for any reason (19 vs. 6, P = 0.018) and for dislocation (8
vs. 1, P = 0.031). Mean PMA scores at last follow-up were comparable in the AVN group (17.65 ± 1.27
[range, 10–18]) and osteoarthritis group (17.59 ± 1.32 [range, 14–18]) (P = 0.139). Osseointegration was
also similar in the two groups: global Engh score, 26.51 ± 1.81 (range, 14–27) for AVN and 26.84 ± 0.91
(range, 19.5–27) for osteoarthritis (P = 0.065); femoral ARA score, 5.83 ± 0.46 (range, 3–6) for AVN and
5.90 ± 0.42 (range, 3–6) for osteoarthritis (P = 0.064); and cup ARA score, 5.74 ± 0.67 (range, 3–6) for AVN
and 5.78 ± 0.66 (range, 3–6) for osteoarthritis (P = 0.344).
Discussion: Survival in this study was good and consistent with recent data on AVN, with no difference
between AVN and osteoarthritis. Revisions for any cause or for dislocation were more common after
THA for AVN. Functional outcomes were similar in the AVN and osteoarthritis groups. An anatomical
cementless prosthesis combined with metal-on-metal 28-mm bearing provides durable good outcomes.
Level of evidence: III, non-randomized comparison of two prospective cohorts.
Published by Elsevier Masson SAS.

∗ Corresponding author. Tel.: +33 561 775 576; fax: +33 561 775 696.
E-mail address: d.ancelin@yahoo.fr (D. Ancelin).

http://dx.doi.org/10.1016/j.otsr.2016.08.021
1877-0568/Published by Elsevier Masson SAS.
1030 D. Ancelin et al. / Orthopaedics & Traumatology: Surgery & Research 102 (2016) 1029–1034

Table 1
Distribution of the causes of avascular necrosis of the femoral head.

Number of patients Percentage

Idiopathic 101 67.8


Organ transplantation 12 8.1
Dyslipidaemia 3 2.0
HIV infection 4 2.7
Alcohol abuse 11 7.4
Glucocorticoid therapy 12 8.1
Myeloproliferative disorder 2 1.3
Lupus 3 2.0
Sickle cell disease 1 0.7
Total 149 100.0

1. Introduction

Total hip arthroplasty (THA) is now the most widely used sur-
gical procedure in the treatment of avascular necrosis (AVN) of the
femoral head [1]. At the Hip Society symposium held in 2013, a sig-
nificant increase in the use of THA to treat AVN and a sharp decline
in conservative procedures were reported [2].
Nevertheless, the outcomes of THA for femoral head AVN remain
controversial, particularly when cementless implants are used
[3–8]. The few studies comparing THA for AVN and osteoarthritis
showed poorer outcomes in the AVN groups. Recently, however,
improvements in outcomes of cementless THA for AVN have been
reported [9,10]. It has been suggested that the poorer outcomes of
THA for AVN may be related to the cause of AVN or to a history of
hip surgery before THA [11–14].
We therefore conducted a prospective case-control study to
determine if differences existed between THA for AVN and
osteoarthritis in terms of (a) survival, (b) complication rates, (c)
functional outcomes and radiographic outcomes, (d) and to deter-
mine whether specific risk factors for THA failure exist in femoral
head AVN. Our working hypothesis was that survival of anatomical
cementless metal-on-metal 28-mm THA was similar in AVN and
osteoarthritis.

2. Material and methods

2.1. Patients

From 1997 to 2007, a single-center prospective study included


consecutive patients undergoing THA for AVN or osteoarthri-
tis. Inclusion criteria were age younger than 65 years at THA
and implantation of the OmnicaseTM anatomical cementless stem
(Zimmer, Warsaw, IN, USA) and of a SchusterTM cementless
metal-on-metal 28-mm cup (Zimmer). Exclusion criteria were
posttraumatic osteoarthritis, inflammatory hip disease, secondary
hip osteoarthritis, large-diameter metal-on-metal bearings, and
non metal-on-metal bearings.
In all, 282 patients were included, 149 with AVN and 133
with osteoarthritis (Fig. 1). Mean age was 47.8 ± 10.2 years (range,
18.5–65.0 years) and mean follow-up was 11.4 ± 2.8 years (range,
4.5–18.3 years). Table 1 lists the causes of AVN and Table 2 the
main patient characteristics in the two groups. The AVN group had
a younger mean age (44.7 vs. 51.9 years) and higher proportions
Fig. 1. Study flow chart. THA: total hip arthroplasty; AVN: avascular necrosis of the
of males (male/female ratio, 3.68 vs. 1.16) and of patients with
femoral head; OA: primary hip osteoarthritis.
bilateral involvement (68 vs. 22). Of the 149 patients with AVN, 51
(34%) had a history of core decompression using an 8-mm trephine
followed by autologous cancellous bone grafting.
patients (Fig. 2). A posterior approach was used in 212/282 patients,
2.2. Surgical procedure with the minimally invasive variant from 2000 onwards [15]. The
minimally invasive Rottinger antero-lateral approach was used in
A cementless OmnicaseTM stem and cementless 28-mm Schus- 70 patients, 33 with AVN and 37 with osteoarthritis. The approaches
ter cup with a metal-on-metal bearing couple were used in all were similarly distributed in the two groups (P = 0.20).
D. Ancelin et al. / Orthopaedics & Traumatology: Surgery & Research 102 (2016) 1029–1034 1031

Table 2
Characteristics of the two patient groups (avascular necrosis and osteoarthritis).

Avascular necrosis Osteoarthritis P-value

Follow-up, years, mean ± SD (range) 11.6 ± 2.8 (6.5–17.5) 11.1 ± 2.6 (4.5–18.3) 0.140
Age at THA, mean ± SD (range) 44.7 ± 9.4 (20.8–64.0) 52.0 ± 9.7 (18.5–65.0) < 0.01
Male-to-female ratio 3.68 1.16 < 0.01
n (%) of patients evaluated 149 (100%) 133 (100%) –
ASA 1: 110 (73.8%) 1: 100 (75.1%) 0.720
score 2: 30 (20.2%) 2: 28 (21.1%)
3: 9 (6%) 3: 5 (3.8%)
Bilateral involvement 68 (45.6%) 22 (16.5%) < 0.01
Core decompression 51 (34.2%) – –

variables relied on the Chi-square test, or on Fisher’s exact test if


the expected theoretical sample size was less than 5. Non-normally
distributed quantitative variables were compared using the Mann-
Whitney U test or the Wilcoxon test for paired data. Kaplan-Meier
survival estimates were computed for two events, aseptic loosening
and major revision, with their 95% confidence intervals (95% CIs).
The results were compared between groups using the log-rank test.
A Cox regression model was built to identify risk factors for THA
failure in patients with AVN. Hazard ratios (HRs) with their 95% CIs
were computed to determine whether the cause of AVN or a history
of core decompression was associated with THA survival.
Values of P lower than 0.05 were considered significant. Statis-
tical tests were run using SPSS Statistics v21.0 software (Chicago,
IL, USA).

3. Results

Overall, 10-year survival to aseptic loosening was 98.9% (95%


Fig. 2. Radiograph showing bilateral cementless total hip arthroplasty with Omni- CI, 98.2–99.6) and 10-year survival to major revision was 93.9%
case stems and Schuster cups implanted to treat avascular osteonecrosis in a male, (95% CI, 98.6–95.5). For neither event was 10-year survival sig-
aged 37 years, at the first THA. This radiograph was taken 11.2 years after the right
THA and 10.8 years after the left THA.
nificantly different between the AVN and osteoarthritis groups,
given the available sample sizes: aseptic loosening, 98.6% (95% CI,
97.6–98.6) and 99.2% (95% CI, 98.4–100), respectively; and major
2.3. Assessments revision, 92.5% (95% CI, 90.2–94.8) and 95.3% (95% CI, 92.9–97.7),
respectively (Table 3). No patient experienced aseptic loosening or
Follow-up data including functional and radiographic outcomes required major revision only at the stem.
were collected on standardized paper forms until 2007 and in Revision for any reason was performed in a larger number of
an electronic database thereafter (OrthoWaveTM, Aria Software, patients with AVN than with osteoarthritis (19 vs. 6; P = 0.018).
Arras, France). All data available until 1st September 2014 were One or more dislocation episodes occurred in 9 patients with AVN
recorded for the study. Patients who had not been seen for 2 years and 3 with osteoarthritis. Revision for dislocation was significantly
or more were contacted. Data of patients who were lost to follow- more common in the AVN group (8 vs. 1; P = 0.031). The number of
up (AVN, n = 12; and osteoarthritis, n = 15) or had died (AVN, n = 14; infections was non-significantly higher in the AVN group (6 vs. 2)
and osteoarthritis, n = 4) but who had been re-evaluated at least (Table 4). Time to revision surgery was significantly shorter in AVN
5 years after THA were included in the analysis. For all patients, (4.1 ± 4.0 years [range, 0.1–10.2 years] vs. 8.0 ± 2.3 years [range,
data on survival to aseptic loosening, survival to major revision, 4.4–10.9 years], P = 0.035). With the available sample sizes, mean
history of core decompression, and complications were available. PMA score at last follow-up was similar in the groups with AVN and
The cause of AVN was recorded; when no cause was identified, AVN osteoarthritis (17.65 ± 1.27 [range, 10–18] and 17.59 ± 1.32 [range,
was classified as idiopathic. The functional outcome at last follow- 14–18], respectively).
up was assessed based on the Postel-Merle d’Aubigné (PMA) score Osseointegration was similar in the AVN and osteoarthritis
[16]. To evaluate implant osseointegration, the Engh-Massin crite- groups, with the available sample sizes: mean global Engh score,
ria [17–19] and Agora Roentgenographic Assessment (ARA) score 26.5 ± 1.8 and 26.8 ± 0.9, respectively; mean femoral ARA score,
[20] were determined on the most recent radiographs. Ectopic ossi- 5.8 ± 0.4 and 5.9 ± 0.4, respectively; and mean acetabular ARA
fications were assessed based on the score developed by Brooker
et al. [21]. Table 3
Kaplan-Meier survival estimates (percentage and 95% confidence interval) after
10 years.
2.4. Statistical methods
Event Avascular necrosis Osteoarthritis P-value
According to a posteriori sample size estimation, with the ␣ risk Aseptic loosening 98.6% ± 1% 99.2% ± 0.8% 0.638
set at 5% and assuming a 6% basal risk of failure to detect a survival Femur only 100% 100% –
Cup only 98.7% ± 0.7% 99.2% ± 0.8% 0.638
difference with 80% power, 246 patients were required in all.
Descriptive statistics were computed after applying the Major revision 92.5% ± 2.3% 95.3% ± 2.4% 0.167
Kolmogorov-Smirnov method to determine whether the data were Femur only 100% 100% –
Cup only 95.4% ± 1.9% 97.2% ± 1.6% 0.421
normally distributed. Between-group comparisons of qualitative
1032 D. Ancelin et al. / Orthopaedics & Traumatology: Surgery & Research 102 (2016) 1029–1034

Table 4 Table 7
Details on revisions. Ectopic ossifications classified according to Brooker et al. [21].

Avascular necrosis Osteoarthritis P-value Ectopic ossifications Avascular necrosis Osteoarthritis P-value

Revision for any 19 6 0.018 Brooker class NS


reason I 3 1
Aseptic 2 1 0.630 II 3 3
loosening III – 6
Infection 6 2 0.319 IV 1 –
Dislocation 8 1 0.031
NS: non-significant.
Metallosis 2 1 0.650
Other 1 1 –
(ectopic
ossification.
4. Discussion
fracture)
Major revision 10 4 0.154
Aseptic 2 1 0.630 This study demonstrated good survival of anatomical cement-
loosening less metal-on-metal 28-mm THA [22–26]. Overall, 10-year survival
Infection 2 1 0.645 was 98.9% (95% CI, 98.2–99.6) for aseptic loosening and 93.9% (95%
Dislocation 4 1 0.233
CI, 98.6–95.5) for major revision. The 10-year survival rates for
Metallosis 2 1 0.650
both events were similar in the AVN and osteoarthritis groups.
Dislocation 9 3 0.117 No patient had aseptic loosening or major revision for the femoral
Time to revision 4.07 ± 3.95 (0.08–10.23) 7.98 ± 2.31 (4.4–10.9) 0.035 stem only. Survival in the AVN group was consistent with the most
(years), recently published data [8,10,27–29].
mean ± SD
This study has several limitations. (a) The sample size was
(range)
limited, but patients were recruited at a single center, and a sin-
gle type of implant with a metal-on-metal bearing couple was
used. (b) Age and gender distribution differed between the two
groups. However, such differences are inevitable, since AVN pre-
dominates in young males. (c) The design was not randomized. A
score, 5.7 ± 0.6 and 5.7 ± 0.6 for OA (NS) (Table 5). According to case-control comparison with prospective data collection was per-
the Engh score, 282 femoral stems were integrated into the bone formed instead. Furthermore, the post hoc sample size estimation
at last follow-up (global score > 10). According to the ARA score, for the primary outcome supports the validity of our findings. (d)
osseointegration was excellent for 274 (97.2%) femoral stems and We did not assess patient satisfaction or quality of life (e.g., using
267 (94.7%) cups (Table 6). Ectopic ossifications occurred in similar the SF-36 or WOMAC). Nevertheless, the PMA score is a good and
numbers of patients in the two groups (AVN, n = 7; and osteoarthri- robust indicator of functional outcome. (e) Measurements on radio-
tis, n = 10) (Table 7). A Brooker class IV peri-articular ossification graphs are subject to bias. However, Orthowave software enables a
developed in a patient with AVN and required revision surgery due systematic analysis of the images and provides reproducible mea-
to range-of-motion limitation. surements. (f) Metal ion assays were not performed routinely but

Table 5
Implant osseointegration assessed using the Engh score [17] and Agora Roentgenographic Assessment (ARA) score [20] in the groups with avascular necrosis and osteoarthritis
(means values with their 95% confidence intervals).

Overall population Avascular necrosis Osteoarthritis P-value

Global Engh [17] 26.66 ± 1.46 (14–27) 26.51 ± 1.81 (14–27) 26.84 ± 0.91 (19.5–27) 0.065
Engh Fixation [17] 9.78 ± 1.05 (3–10) 9.68 ± 1.25 (3–10) 9.88 ± 0.74 (5–10) 0.115
Engh Stability [17] 16.88 ± 0.73 (9–17) 18.82 ± 0.97 (9–17) 16.96 ± 0.31 (14.5–17) 0.198
ARA Femur [20] 5.86 ± 0.44 (3–6) 5.83 ± 0.46 (3–6) 5.90 ± 0.42 (3–6) 0.064
ARA Cup [20] 5.76 ± 0.66 (3–6) 5.74 ± 0.67 (3–6) 5.78 ± 0.66 (3–6) 0.344

Table 6
Comparison of implant osseointegration assessed in categories based on the Engh score [17] and Agora Roentgenographic Assessment (ARA) score [20] in the groups with
avascular necrosis and osteoarthritis.

Overall population Avascular necrosis Osteoarthritis P-value

Global Engh [17]


> 10: confirmed bone growth 282 149 133 –
0–10: probable bone growth – – –
(−10)–10: fibrous encapsulation – – –
< −10: unstable – – –

ARA Femur [20]


> 5: excellent 274 (97.2%) 145 (97.1%) 129 (96.9%) NS
4: good 6 (2.1%) 3 (2%) 3 (2.3%)
3: fair 2 (0.7%) 1 (0.7%) 1 (0.8%)
< 3: poor

ARA Cup [20]


> 5: excellent 267 (94.7%) 140 (93.9%) 127 (88%) NS
4: good 4 (1.4%) 4 (2.7%) 10 (7.5%)
3: fair 11 (3.9%) 5 (3.4%) 6 (4.5%)
< 3: poor

NS: non-significant.
D. Ancelin et al. / Orthopaedics & Traumatology: Surgery & Research 102 (2016) 1029–1034 1033

are not recommended for monitoring small-diameter metal-on- Disclosure of interest


metal implants [30]. (g) Activity levels were not measured, but
our primary objective was to compare survival to aseptic loosening David Ancelin, Nicolas Reina, Etienne Cavaignac, and Stéphanie
and major revision after metal-on-metal 28-mm THA for AVN vs. Delclaux declare that they have no competing interest.
osteoarthritis. To achieve this objective, the sample size was ade- Philippe Chiron declares a conflict of interest with Zimmer in
quate, as shown by the sample size estimation, and the follow-up relation to this work and is a consultant for Adler.
seems sufficient.
Revision for any reason was more common in the AVN group
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