Abstract
Background: Recent randomized, controlled trials performed at two
years postoperatively have shown that a primary total hip replacement is
superior to internal fixation for the treatment of a displaced femoral neck
fracture in a relatively healthy, mentally competent, elderly patient. The
primary aim of the present study was to evaluate the outcomes at four
years.
Methods: One hundred and two patients (mean age, eighty years) who
had an acute displaced femoral neck fracture were randomly allocated to be
treated with total hip replacement or internal fixation. The inclusion
criteria were an age of at least seventy years, absence of severe cognitive
dysfunction, an independent living status, and the ability to walk
independently. The main outcome measurements were hip complications,
reoperations, hip function, and health-related quality of life.
Results: The mortality rate was 25% in both groups. At the
forty-eight-month follow-up evaluation, the rate of hip complications was 4%
in the patients treated with total hip replacement and 42% in those treated
with internal fixation (p < 0.001) and the reoperation rates were 4% and
47%, respectively (p < 0.001). The arthroplasty group had no additional hip
complications or reoperations between the twenty-four and forty-eight-month
follow-up visits. In the fixation group, the percentage of hip complications
increased from 36% to 42% and the percentage of reoperations increased from
42% to 47% during the same period. The hip function was significantly better
and the decline in health-related quality of life was less pronounced in the
arthroplasty group than it was in the fixation group at the four, twelve, and
twenty-four-month follow-up evaluations. Ninety-seven percent of the patients
in the arthroplasty group and 57% of the patients in the fixation group who
were available for follow-up at forty-eight months had no hip complications (p
< 0.001).
Conclusions: Compared with internal fixation, primary total hip
replacement provides a better outcome for mentally competent elderly patients
with a displaced femoral neck fracture. The complication and reoperation rates
were significantly lower and hip function and health-related quality of life
were at least as good at four years after the surgery.
Level of Evidence: Therapeutic Level I. See Instructions
to Authors for a complete description of levels of evidence.
The optimal treatment for an acute displaced femoral neck fracture
in an elderly patient is still under debate. There is a growing opinion that
the outcome would be improved by a more patient-related, rather than a
strictly diagnosis-related, approach—that is, the treatment should be
based on the patient's age, functional demands, and individual risk
profile1. The goal
of future research should be to identify selection criteria by which we can
identify subgroups of patients that would be optimally treated by any of the
surgical methods available—i.e., internal fixation, hemiarthroplasty, or
total hip
replacement2. The
population of elderly patients with femoral neck fracture comprises several
subpopulations, ranging from the mentally competent, relatively healthy,
active patient who is capable of living independently and has a long life
expectancy to the institutionalized, cognitively impaired, bedridden patient.
It is not likely that one method would be optimal for all of the
subpopulations.
A number of recent randomized, controlled trials have shown that, for a
relatively healthy, active, and lucid patient, a primary total hip replacement
is superior to internal fixation regarding the need for secondary surgery, hip
function3-8,
and the health-related quality of
life3. The follow-up
period in these trials has been limited to two years except in the study by
Neander5 (which was
partly randomized) and that by Ravikumar and
Marsh8, in which the
durations of follow-up were four and thirteen years, respectively. However,
neither of those trials included an assessment of the health-related quality
of life.
It has often been claimed that hip function following uneventful healing of
a displaced femoral neck fracture will always be better than that following a
hip arthroplasty. Since this select group of relatively healthy elderly
patients is likely to have a longer life expectancy than the other elderly
subgroups, it is important to evaluate the outcome, including both hip
function and health-related quality of life, after a longer duration of
follow-up.
In the present study, we examined the four-year follow-up results for
elderly patients with a displaced femoral neck fracture who had been included
in a previously published randomized, controlled trial comparing internal
fixation with total hip
replacement3. The
primary aim of the present study was to determine whether the superior
outcomes of primary total hip replacement, as compared with the results of
internal fixation, in mentally competent elderly patients (at least seventy
years old) with a displaced femoral neck fracture persisted at the time of a
four-year follow-up. The secondary aim was to describe the health-related
quality of life for the two treatment groups within the same period.
The previously published randomized, controlled
trial3 included 102
patients with an acute displaced femoral neck fracture (Garden stage III or
IV9). Eighty-two
(80%) of the patients were female, and the mean age was eighty years (range,
seventy to ninety-six years). The inclusion criteria were an age of at least
seventy years, the absence of severe cognitive dysfunction (at least three
correct answers on a ten-item mental test [the Short Portable Mental Status
Questionnaire10]),
independent living status, and the ability to walk independently with or
without walking aids. Patients with a pathological fracture, a displaced
fracture that had been sustained more than twenty-four hours before
presentation, or rheumatoid arthritis or osteoarthritis were not included.
After clearance by an anesthetist, the patients were randomized, with a
sealed-opaque-envelope technique, to be treated with internal fixation with
two cannulated screws or to be treated with a primary total hip replacement
(Fig. 1).
Internal fixation was carried out with the patient on a fracture table. The
fractures were reduced with closed methods, with the aid of an image
intensifier, and were fixed internally with two cannulated screws (Olmed;
DePuy/Johnson and Johnson, Sollentuna, Sweden). The goals for screw
positioning were modified from the recommendations by Lindequist and
Törnkvist11.
The reduction was categorized as good (displacement of <2 mm, a Garden
angle of 160° to 175°, and posterior angulation of <10°), fair
(displacement of <5 mm, a Garden angle of 160° to 175°, and
posterior angulation of <20°), or poor (displacement of >5 mm, a
Garden angle of <160° or >175°, and posterior angulation of
>20°). The position of the screw was categorized as good if its tip was
<5 mm from the subchondral bone. As viewed in the anteroposterior
projection, the distal screw was aimed to be introduced at the level of the
lesser trochanter and to lie on the calcar femorale. The proximal screw was
introduced at least 2 cm from, and parallel to, the distal screw, with an
angle of <10° between the two screws. As viewed in the lateral
projection, the screws were supposed to be parallel and positioned in the
central or posterior third of the femoral head and neck.
Total hip replacement was carried out with use of the modified Hardinge
approach12, with
the patient in the lateral decubitus position. An Exeter modular stem
(Howmedica, Malmö, Sweden) with a 28-mm head and an Ogee acetabular
component (DePuy/Johnson and Johnson, Sollentuna, Sweden) were implanted.
The patients in both groups were allowed to walk with full weight-bearing
as tolerated. The patients who were treated with the total hip replacement
were informed about mobilization techniques and were allowed to sit on a high
chair immediately after the surgery and to stop using crutches at their own
convenience. After six weeks, there were no restrictions. All operations were
performed by one of two surgeons (J.T. or H.T.) who were experienced with both
procedures.
The perioperative details and the results at the four, twelve, and
twenty-four-month follow-up evaluations have been reported
previously3. There
were no significant preoperative differences between the groups regarding age,
gender, cognitive
function10, ability
to carry out activities of daily
living13, walking
ability, or
comorbidities14
(Table I).
The present study included clinical and radiographic examination at
approximately forty-eight months (mean [and standard deviation], 48.8 ±
1.6 months). Fracture-healing, hip complications, ability to carry out
activities of daily living, ability to live independently, new fractures of
the lower extremity, hip function, and health-related quality of life were
assessed. All clinical variables except hip motion were assessed by an
unbiased observer (a research nurse who was not involved in the surgery or
clinical decisions). That observer was not blinded with regard to the type of
surgical intervention.
Comorbidity14
was graded as A (healthy), B (another illness not affecting rehabilitation),
or C (another illness that affected rehabilitation).
The ADL (activities of daily living) index described by Katz et
al.13 was used to
evaluate the functional independence or dependence of patients with regard to
bathing, dressing, using the toilet, transferring, continence, and feeding. An
ADL index of A indicates independence in all six functions; an index of B
indicates independence in all but one of the six functions; and indices of C
through G indicate dependence on another for bathing and at least one more
function.
Living conditions were categorized as independent (living in one's own home
or in housing for the elderly) or as institutionalized (living in a care group
for demented patients or in a nursing home).
Hip complications in the fixation group were defined as nonunion,
osteonecrosis, or peri-implant fracture. Local pain from protruding screws was
not defined as a hip complication. The fracture was defined as healed if there
were visible trabeculations across the fracture line and no signs of
osteonecrosis. Nonunion was defined as an absence of radiographically visible
trabeculations across the fracture line and included early redisplacement or
progressive displacement. Hip complications in the arthroplasty group were
recorded as dislocation, periprosthetic fracture, or radiographic signs of
loosening of the
femoral15 or
acetabular16
component.
Charnley's numerical
classification17
defines the clinical state of the affected hip joint in terms of pain,
movement, and walking ability. Each dimension is graded on a scale of 1 to 6,
with 1 indicating total disability and 6 indicating a normal state. The mean
value and the percentage of patients with the best scores (5 and 6) for each
dimension were determined.
The health-related quality of life was rated with use of the EuroQol-5D
(EQ-5D) index18. An
EQ-5D index score of 0 indicates the worst possible health state, and a value
of 1 indicates full health.
In the outcome analysis, all patients who had been included in the study
remained in their primary randomization group according to the
intention-to-treat principle, regardless of secondary procedures. The patients
who were lost to follow-up had been followed for as long as possible, and
their results are presented separately.
The study was performed according to the Helsinki Declaration. All patients
gave informed consent to participate, and the protocol was approved by the
local ethics committee.
Statistical Methods
The analyses were performed with SPSS 12.0.1 for Windows (SPSS, Chicago,
Illinois) statistical software. All scale variables were tested for normality
with the Kolmogorov-Smirnov test. The Student t test was used for parametric
scale variables in independent groups. The Mann-Whitney U test was used for
nonparametric scale variables and ordinal variables in independent groups.
Nominal variables were tested with the chisquare test or the Fisher exact
test. All tests were two-sided. The results were considered significant at p
< 0.05. Trend values (0.05 = p < 0.1) are displayed in this paper,
and all other values are reported as not significant. In order to maximize the
power of the statistical tests, we did not apply any correction factor (such
as Bonferroni correction) to the p values, which may increase the possibility
of a Type-I error.
In our previously published two-year-follow-up
study3, the fracture
reduction was considered to be good in forty-six (87%) of the fifty-three
patients in the fixation group and fair in the remaining seven. The screw
position was thought to be good in fifty-one (96%) of the fifty-three
patients. The stem position was considered to be good in forty-eight (98%) of
the forty-nine patients in the arthroplasty group, and the stem was in 8°
of varus in one patient. The acetabular component was in a good position in
forty-four (90%) of the forty-nine patients. The lateral opening was increased
by 5° to 8° in the five remaining patients, one of whom also
demonstrated 6° of retroversion. The operatively treated limb was
lengthened by a mean of 6 mm (range, -10 to +24 mm). There were two
superficial infections in the arthroplasty group but no deep infections. The
failure rate, with regard to hip complications and the number of patients
undergoing a reoperation, was higher in the fixation group than in the
arthroplasty group.
Surgical Outcome for All Patients
The surgical outcomes after forty-eight months are shown in
Figure 1. In the entire study
population, including the patients who later died (25% of the population) or
were lost to follow-up (5%), the rate of hip complications was 4% (two of
forty-nine) in the arthroplasty group and 42% (twenty-two of fifty-three) in
the fixation group (p < 0.001); nonunion occurred in 23% of the patients in
the fixation group and osteonecrosis, in 19%. The rate of reoperations was
significantly higher in the fixation group (47% [twenty-five of fifty-three]),
with 34% having a subsequent arthroplasty and 13%, screw removal) than it was
in the arthroplasty group (4% [two of forty-nine]) (p < 0.001). Three of
the patients in the fixation group who underwent a total hip replacement had
had a previous operation for screw removal, which was not included among the
reoperations for the analysis. The differences between the groups regarding
reoperations were still significant if only the major reoperations (the
arthroplasties) were counted in the fixation group (p < 0.001).
The mortality rate was 24% (twelve of forty-nine) in the arthroplasty group
and 25% (thirteen of fifty-three) in the fixation group (difference not
significant). A life-table analysis of the percentage of surviving patients
who had not had a reoperation is displayed in
Figure 2.
Eight patients (16%) in the arthroplasty group and ten (19%) in the
fixation group had a new fracture involving the lower extremities during the
four-year follow-up period (difference not significant). There were four
femoral neck fractures, three trochanteric fractures, and one periprosthetic
fracture in the arthroplasty group and eight femoral neck fractures, one pubic
ramus fracture, and one tibial condylar fracture in the fixation group. There
were no ipsilateral peri-implant fractures in the fixation group.
Of the 102 patients, five (5%) were lost to follow-up before forty-eight
months postoperatively; three of these patients were in the fixation group,
and two were in the arthroplasty group. Of the three patients in the fixation
group, one had undergone a hemiarthroplasty to treat a nonunion at twenty-two
months and was seen at the two-year follow-up evaluation, one patient was lost
to follow-up after the two-year visit, and one was lost to follow-up after a
four-month visit. In the arthroplasty group, one of the patients lost to
follow-up had a dislocation and underwent a revision of the acetabular
component and lengthening of the neck of the prosthesis at six months, after
which the dislocation did not recur. The patient had good hip function at the
twelve-month follow-up evaluation and then refused to return for additional
examinations; however, he reported satisfactory hip function in a telephone
interview at forty-eight months after the primary surgery. The other patient
in the arthroplasty group who was lost to follow-up had a good outcome at the
two-year follow-up visit.
Surgical Outcome for Patients Available for Follow-up at Forty-Eight
Months
In the arthroplasty group, one (3%) of thirty-five patients available for
follow-up at forty-eight months had had a hip complication and a reoperation.
This patient sustained a periprosthetic fracture in a fall six weeks after the
primary operation and was treated with internal fixation of the fracture, with
an uneventful outcome. One additional patient in the arthroplasty group had a
reoperation—a revision arthroplasty due to dislocations six months after
the primary surgery. This patient was later lost to follow-up, as mentioned
above. There were no hip complications in the arthroplasty group between
twenty-four and forty-eight months, and there were no radiographic signs of
loosening of the components in any of the patients at the four-year follow-up
evaluation.
In the group treated with internal fixation, sixteen (43%) of the
thirty-seven patients available for follow-up at forty-eight months had had a
fracture-healing complication. Twelve (32%) of the thirty-seven had undergone
an arthroplasty (a total hip replacement in eleven of them), and seven (19%)
had had the fixation screws removed. All patients with a nonunion but only
five of the nine patients with osteonecrosis underwent an arthroplasty. Two of
the patients with osteonecrosis had screw removal only. Between the
twenty-four and forty-eight-month follow-up evaluations, the percentage of
fracture-healing complications increased from 36% to 42% and the percentage of
reoperations increased from 42% to 47%.
Functional Outcome and Health-Related Quality of Life
There were no differences in the ADL index between the groups at the four,
twelve, and twenty-four-month follow-up evaluations. At forty-eight months,
81% of the patients in the arthroplasty group and 70% in the fixation group
had an ADL index of A or B (difference not significant). This finding
reflected a deterioration compared with the twenty-four-month ADL indices,
which were A or B in 90% and 88%, respectively.
The Charnley hip scores are presented in
Table II. The hip function was
generally better in the arthroplasty group at the four, twelve, and
twenty-four-month follow-up evaluations, but there was no significant
difference between the groups with regard to hip function at forty-eight
months. Both groups had a marked reduction in walking ability at forty-eight
months compared with the ability at twelve and twenty-four months.
The health-related quality of life according to the EQ-5D index score was
better in the arthroplasty group at each follow-up point, but the differences
were significant only at four months (p < 0.005) and twelve months (p <
0.05) (Fig. 3). The change in
the EQ-5D index score between the time that the patient was included in the
study and each follow-up evaluation (four, twelve, twenty-four, and
forty-eight months) is shown in Table
III. The decline in the score was more pronounced in the fixation
group, but, with the numbers available, the difference between the groups at
the forty-eight-month follow-up evaluation was not significant.
Among the patients available for follow-up at forty-eight months,
thirty-four (97%) of the thirty-five in the arthroplasty group and twenty-one
(57%) of the thirty-seven patients in the fixation group remained without a
hip complication (p < 0.001). The hip function and health-related quality
of life of these patients are shown in
Table IV.
At forty-eight-months, there was a trend toward a higher percentage of
patients living independently in the arthroplasty group (89%; thirty-one of
thirty-five) than in the fixation group (70%; twenty-six of thirty-seven) (p =
0.082).
The benefit of primary total hip replacement compared with internal
fixation for the treatment of a displaced femoral neck fracture in a
relatively healthy, cognitively intact, elderly patient is apparent even at
four years postoperatively. The rate of hip complications and the need for
secondary surgery are lower, and hip function and health-related quality of
life are as good.
The rate of hip complications in the fixation group continued to increase,
from 36% at twenty-four months to 42% at forty-eight months, and the
reoperation rate increased from 42% to 47%. The increase in hip complications
was due to detection of osteonecrosis in a number of patients after the
twenty-four-month follow-up evaluation; the total rate of osteonecrosis was
19% at forty-eight months, and the rate of nonunions was 23%. This increase
was in contrast to the outcome in the arthroplasty group, in which the rate of
hip complications and the rate of reoperations each remained unchanged at 4%.
According to the current state of the art, the fracture reduction and screw
position were optimal in the vast majority of the patients in the fixation
group, and the outcomes in that group at twenty-four months were equal to or
better than those reported in most other studies. This is confirmed by the
meta-analysis by Lu-Yao et
al.19, in which the
hip complication rate was 49%, with a 33% rate of nonunion and a 16% rate of
osteonecrosis. In a large meta-analysis focusing on the choice of implant in
almost 5000
patients20, screws
(as used in our study) appeared to be superior to pins, but there is no
clinical evidence that the use of three or more screws is superior to the use
of two screws.
There were no additional complications in our arthroplasty group between
the twenty-four and forty-eight-month follow-up evaluations. The dislocation
rate remained low at 2% and was on par with what can be expected after an
elective total hip replacement in patients with osteoarthritis or rheumatoid
arthritis. This low rate compares favorably with the dislocation rates (range,
9% to 22%) in other randomized, controlled trials of primary total hip
replacement in patients with a femoral neck
fracture5-8,21.
The surgical approach was through a trochanteric osteotomy in the study by
Jonsson et al.7 and
was posterolateral in all of the
others5,6,8,21.
The low rate of dislocation in our series is probably explained by our
inclusion criteria, which were an ability to walk and live independently and,
most importantly, no severe cognitive dysfunction. In the study by Johansson
et al.6, the
dislocation rate was 32% in patients with mental dysfunction compared with 12%
in lucid patients. Assessment of cognitive function with a validated
instrument, such as the Short Portable Mental Status Questionnaire
(SPMSQ)10 used in
our study, is advantageous, especially with regard to facilitating the
implementation of the findings in future treatment protocols. Additionally, we
believe that the anterolateral surgical approach has advantages over the
posterolateral approach regarding stability of the hip joint, which is of
crucial importance in patients with this particular
diagnosis5,6,8,21-23.
The four-year mortality rate of 25% in both groups in our study was lower
than the two-year mortality rate in most series in which the patients were not
selected on the basis of walking ability, living conditions, and cognitive
function1. The 25%
rate is in sharp contrast to the finding of a study in which patients were
selected if they were able to walk independently but had severe cognitive
dysfunction (an SPMSQ score of
<3)24. In that
study, in which the patients were randomized to be treated with internal
fixation or primary hemiarthroplasty, the two-year mortality rate was 42%. The
expected longer survival of the patients selected for our study emphasizes the
importance of a primary procedure with durable results. Total hip replacement
seems to provide good long-lasting function. According to the Swedish National
Hip Arthroplasty Register, 98% of patients in whom a hip fracture was treated
with total hip replacement did not have a revision within eleven
years25. Given the
expected mean duration of survival of a seventy-year-old Swedish woman and man
(sixteen and thirteen years,
respectively)26, it
appears that most primary total hip replacements in patients older than
seventy years of age will last throughout their remaining life span, provided
that they do not have an early complication. This contention is also supported
by the four-year follow-up study by
Neander5 and the
thirteen-year follow-up study by Ravikumar and
Marsh8. In the
latter study, in which internal fixation, cementless hemiarthroplasty, and
total hip replacement were compared, the thirteen-year revision rates were
33%, 24%, and 7%, respectively. Hip function was best in the total hip
replacement group and worst in the hemiarthroplasty group. This unfavorable
outcome of cementless hemiarthroplasty was confirmed by the 1986 study by Dorr
et al.27.
In our study, hip function was significantly better and the decline in
health-related quality of life was less pronounced in the arthroplasty group
than in the fixation group at the four, twelve, and twenty-four-month
follow-up evaluations, but the differences were no longer significant at the
forty-eight-month evaluation. The scores for hip pain in the fixation group
were markedly improved between the twenty-four and forty-eight-month follow-up
evaluations, probably reflecting the fact that the majority of the patients
with hip complications had undergone a reoperation. All patients with a
nonunion and five of the nine with osteonecrosis had an arthroplasty, and
eleven of the twelve patients who had an arthroplasty had a total hip
replacement. Additionally, 19% of the patients had had the screws removed. Of
the patients in whom the fracture healed uneventfully, 24% underwent screw
removal. There was an obvious deterioration in walking ability and
health-related quality of life between the twenty-four and forty-eight-month
follow-up evaluations in both groups, probably reflecting the natural course
of aging, the increased frequency of comorbidities, and new fractures of the
lower extremity. Eighteen percent of all patients sustained a new fracture of
the lower extremity, and the fractures were predominately of the hip.
In a randomized, controlled trial comparing internal fixation with total
hip replacement, it is inevitable that the difference in hip function and
health-related quality of life between the two groups will decrease with time
(in an intention-to-treat analysis) as a result of a substantial proportion of
salvage arthroplasties being performed in the fixation group. Therefore, it is
important to evaluate the overall outcome—i.e., revision surgery, hip
function, and health-related quality of life—during this relatively long
time period, rather than focusing exclusively on the outcome at the time of
the final follow-up. Four years is a substantial period of the remaining
lifetime of these elderly patients.
The opinion that the outcome following uneventful healing of a displaced
femoral neck fracture treated with internal fixation is better than that of an
arthroplasty seems not to be true when internal fixation is compared with
primary total hip replacement in a group of relatively healthy, mentally
competent patients. In the group of patients with an uneventful outcome, those
treated with arthroplasty had better absolute values for hip function and
health-related quality of life than those treated with internal fixation,
although this difference was not significant at the forty-eight-month
follow-up evaluation. Thus, the hip function and health-related quality of
life at four years after the hip arthroplasties were at least as good as those
following uneventful healing of internally fixed fractures.
The number of patients enrolled in this trial limited its statistical power
for detecting differences in hip function and health-related quality of life,
especially with the mortality rate reducing the number of patients available
for long-term follow-up. However, the statistical power was adequate to
confirm the difference in the rate of hip complications and reoperations and
to support the conclusion that, at four years, the hip function and
health-related quality of life provided by total hip replacement are similar
to those provided by internal fixation. The fact that the nurse who performed
the follow-up evaluations was not blinded to the type of surgical intervention
is also a limitation. The questionnaires for most of the outcome variables
were mailed to the patients a week before the scheduled follow-up visit. The
questionnaires were filled out by the patients, and the nurse's task at the
follow-up evaluation was to ensure that all questions had been completed. A
strength of the trial was that only 5% of the patients were lost to follow-up
less than the forty-eight-months postoperatively.
In summary, the results of this study confirm that, at four years
postoperatively, the outcomes of primary total hip replacement are better than
those of internal fixation in mentally competent elderly patients with a
displaced femoral neck fracture. The complication and reoperation rates were
significantly lower following the hip arthroplasties, and the hip function and
the health-related quality of life were similar to those following internal
fixation. The criteria for selecting patients for treatment with total hip
replacement are important, and we recommend use of a validated instrument for
assessing cognitive function. ?
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