Malpositioning of the acetabular component during total hip arthroplasty
increases the risk of
dislocation1,2,
reduces the range of motion free of intra-articular
impingement3, and
may cause long-term
wear4. There have
been numerous reports regarding the optimal orientation of the acetabular
component in total hip
arthroplasty3.
Lewinnek et al.1
recommended an abduction angle of 40° ± 10° and an anteversion
angle of 15° ± 10° as the safe zone for cup orientation in
total hip arthroplasty. Use of mechanical acetabular guides for intraoperative
alignment leads to variations between the actual and desired implant
orientation because it is difficult to know the patient's exact position on
the operating
table5. These
problems have demonstrated a need to develop more reliable tools in order to
prevent malpositioning of the implants and to improve the reproducibility of
implant alignment in total hip arthroplasty. After the initial work of DiGioia
et al.6, a number of
computer-assisted orthopaedic navigation systems have been developed. Some
systems are based on computed tomography images; others are independent of
preoperative imaging and are called imageless navigation. Computed
tomography-based navigation requires intraoperative matching, which increases
blood loss and surgical
time7. Among the
imageless systems, one (Praxim Medivision, Grenoble, France) is based on bone
morphing, technology initially described by Stindel et
al.8 for
computer-assisted knee arthroplasty and later adapted for total hip
arthroplasty. The principle is based on a three-dimensional reconstruction of
a patient's bones from anatomical data collected intraoperatively with a
three-dimensional optical localizer with use of clouds of points and a
three-dimensional statistical deformable
model8. For cup
implantation in total hip arthroplasty, the anterior pelvic plane is
registered intraoperatively by percutaneous palpation. Once this reference
plane is determined, the cup impactor is navigated in order to achieve the
safe zone described by Lewinnek et
al.1 for cup
abduction and anteversion angles. This type of imageless system does not
involve additional radiation exposure and is faster than the intraoperative
matching with computed tomography-based
navigation7,8.
However, the benefits of the use of such an imageless system for cup
positioning have not been demonstrated in vivo, to our knowledge.
We hypothesized that the use of an imageless hip navigation system would
increase the accuracy of cup orientation compared with that achieved with
conventional freehand implantation methods. The first goal of this prospective
randomized comparative study was to validate the system in vivo. The second
goal was to compare computer-assisted with conventional freehand cup
placement.
There were no significant differences in demographic data between the two
study groups, with the numbers available.
There were sixteen men and fourteen women and fourteen right hips and
sixteen left hips in each group. The mean age (and standard deviation) of the
patients was 61.2 ± 13.15 years (range, twenty-four to eighty years) in
the computer-assisted group and 62.6 ± 9.6 years (range, twenty-six to
seventy-eight years) in the freehand-placement group (p = 0.29). The mean
body-mass index was 25.6 ± 4.53 (range, 17 to 37) in the
computer-assisted group and 25.2 ± 4.1 (range, 19.53 to 38.2) in the
freehand-placement group (p = 0.28). The mean alpha angle measured
preoperatively on a standing lateral pelvic radiograph was —1.72°
± 7.5° (range, —15° to 14°) in the computer-assisted
group and 0.6° ± 7.8° (range, —22° to 11°) in the
freehand-placement group (p = 0.29). The etiologies were primary
osteoarthritis in twenty-seven hips and osteonecrosis in three hips in the
computer-assisted group and primary osteoarthritis in twenty-six hips and
osteonecrosis in four hips in the freehand-placement group. The mean diameter
of the acetabular cup was 52 mm in both groups. No additional skin incision
had to be made to accommodate navigation. The mean additional time for the
computer-assisted procedure was twelve minutes (range, eight to twenty
minutes). The correlation between the surgeon's intraoperative subjective
estimation of the abduction and anteversion angles and the angles provided by
the computer-assisted system was graded as high in twenty-three cases, weak in
six, and poor in one.
No patient had a neurovascular complication and no dislocation occurred in
the first year after surgery.
The angles of abduction and anteversion recorded by the imageless
navigation system in the computer-assisted group perioperatively were compared
with the position of the acetabular component postoperatively. The results of
the comparison for the patients with a body-mass index of <27 and for the
patients with a body-mass index of =27 are detailed in Tables
I and
II.
In the freehand-placement group, the mean operative, radiographic, and
anatomical abduction angles, as calculated with the postoperative software,
were, respectively, 32° ± 7.1° (range, 21° to 48°), 34
°± 7.62° (range, 24° to 50°), and 38° ±
8° (range, 28° to 55°) and the mean operative, radiographic, and
anatomical anteversion angles were 16.6° ± 10.4° (range, 0°
to 37°), 16.2° ± 9.6° (range, 2° to 35°), and
20.6° ± 10° (range, 2° to 39°). In the
computer-assisted group, the respective abduction angles were 32° ±
4.8° (range, 25° to 45°), 34° ± 5.7° (range,
25° to 45°), and 40° ± 5.0° (range, 27° to 47°)
and the respective anteversion angles were 14.8° ± 4.6° (range,
6° to 23°), 14.4° ± 4.5° (range, 7° to 25°),
and 18.6° ± 5.0° (range, 9° to 27°). There was no
difference between the computer-assisted group and the freehand-placement
group with regard to the mean abduction angles (p = 0.668, p = 0.113, p =
0.316) or the mean anteversion angles (p = 0.243, p = 0.311, p = 0.312).
According to these results and with use of a 0.80 test power, a minimal
difference of 3.5° in abduction and 5.5° in anteversion would have
been detected. A smaller variation in the positioning of the acetabular
component in the computer-assisted group than in the freehand-placement group
was indicated by the lower standard deviations in the computer-assisted group
for the abduction (p = 0.025, p = 0.066, p = 0.028)
(Fig. 2-A) and anteversion
angles (p < 0.001 in the three referentials)
(Fig. 2-B). The percentage of
outliers was 57% (seventeen of thirty) in the freehand-placement group and 20%
(six of thirty) in the computer-assisted group. This difference in the
percentage of outliers between the two groups was significant (p = 0.002).
The gender comparisons revealed no significant differences in the abduction
or anteversion angles, with the numbers available.
The first goal of this study was to validate this imageless navigation
system in vivo, and the second goal was to compare conventional cup placement
with computer-assisted cup placement. The results of our study demonstrated a
good correlation between intraoperative and postoperative measurements for
patients with a body-mass index of <27. The results did not show any
differences between treatment groups with regard to the mean cup abduction and
anteversion angles, but the computer-assisted-surgery system significantly
reduced the percentage of outliers according to the criteria described by
Lewinnek et al.1,
from 57% (seventeen of thirty) in the freehand-placement group to 20% (six of
thirty) in the computer-assisted group. One of the limitations of this study
was the absence of variation in surgeons' levels of skill in the use of
computer-assisted technology for cup positioning. However, we chose two groups
that were strictly comparable with regard to all parameters, including
surgical approach, surgeon, type of implant, gender, age, body-mass index,
operatively treated side, and disease etiology.
Postoperative measurements on three-dimensional computed tomography
reconstructions allowed comparison between intraoperative and postoperative
abduction and anteversion angles. The anterior pelvic plane, known as the
Lewinnek
plane1,
was the basis for all angle measurements during the procedure with the
navigation software and after the procedure with the postoperative evaluation
software. Thus, three osseous landmarks—the two anterior superior iliac
spines and the pubic symphysis—are necessary in this system. The angles
can be calculated irrespective of the patient and pelvic position. Tannast et
al.13 showed that
measurements of the version of the prosthetic cup on postoperative
anteroposterior radiographs or standard computed tomography scans without
accurate definition of the position of the pelvis are highly inaccurate as a
result of pelvic tilt, rotation, and obliquity. Currently, in almost all
computer-assisted orthopaedic surgery systems that rely on definition of the
anterior pelvic plane, the plane is derived by percutaneously identifying
three osseous landmarks: the anterior superior iliac spines and the pubic
symphysis14-16.
Considering that the registration of the anterior pelvic plane is modified by
subcutaneous fat tissue, we call it the cutaneous Lewinnek plane.
Using a kinematic model, Wolf et
al.14 showed how to
examine the effects of these inaccuracies on the final orientation of the
acetabular cup. Simulation results indicated that if, for example, a surgeon
aimed for 45° of abduction and 20° of anteversion a total error of 4
mm in the measurement of the anterior superior iliac spine and the pubic
tubercles would result in a final cup orientation of 47° and 27° of
abduction and anteversion, respectively, which would be a 2° abduction
error and a 7° anteversion error. Thus, the poor correlation between
intraoperative and postoperative measurements in patients with a body-mass
index of =27 observed in our study was probably due to the limits of the
percutaneous registration of the Lewinnek
plane1. This is
probably one of the most obvious technical limitations of an imageless
anatomical navigation system based on bone morphing in total hip arthroplasty.
Perioperative echographic morphing of the anterior pelvic plane may overcome
this limitation in the future.
The second purpose of our study was to compare computer-assisted acetabular
component positioning with conventional freehand placement. Our study did not
show any differences between the computer-assisted group and the
freehand-placement group with regard to the mean abduction and anteversion
angles, but there were significantly smaller standard deviations in the
computer-assisted group. Furthermore, the use of a computer-assisted surgery
system significantly reduced the percentage of outliers in our study from 57%
(in the freehandplacement group) to 20% (p = 0.002), which is in agreement
with previously reported
findings17-20.
In the study by Wixson and
MacDonald18, 30%
(twenty-five) of eighty-two hips in the computer-assisted group were in the
combined zone of 40° to 45° of abduction and 17° to 23° of
anteversion, whereas only 6% (three) of fifty hips in the freehand-placement
group were. However the postoperative evaluations in these previous studies
were based on conventional radiographic
analysis17-19,
which may prevent direct comparison with our
study8. Kalteis et
al., in a prospective randomized study comparing freehand placement with
computed tomography-based and imageless navigation in total hip arthroplasty,
demonstrated with postoperative computed tomography that navigation
significantly reduced cup orientation
outliers20.
According to Jolles et al., the differences between computer-assisted and
freehand cup placement are greater for less skilled
surgeons17. Thus,
the lack of differences in the mean abduction and anteversion angles between
the two groups in our study could be explained by the senior author's
experience with total hip arthroplasty. We did not observe any complications
related to computer-assisted surgery, and no dislocation or neurovascular
complication was recorded in the two groups. It would be interesting to
replicate this study with a variety of surgeons with different skill levels to
identify differences in cup positioning and calculate complication rates.
The computer-assisted surgery system used in this study, which was based on
bone morphing, reduced the percentage of outliers for cup positioning in total
hip arthroplasty. The next challenge for computer-assisted cup positioning is
threefold. The first, technical concern involves registration of the anterior
pelvic plane during the procedure, especially in obese patients. Echographic
morphing could be a good alternative, and it needs to be validated in a
prospective randomized study. The second challenge is the definition of
optimal cup orientation in terms of abduction and anteversion angles for each
patient. Analysis of the pelvic tilt in our study showed important
inter-individual differences, which should be considered preoperatively to
provide the best anteversion angle intraoperatively. The third issue is the
clinical impact of reducing outliers during cup positioning. The clinical
differences, especially with regard to the dislocation rate, range of motion,
and wear, between patients treated with the computer-assisted system and those
treated with freehand cup positioning need to be evaluated at intermediate and
long-term follow-up time-periods in order to evaluate the additional costs and
operative time involved with these systems. ?