3D-Printed, Patient-Specific Cutting Guides Improve Femoral and Tibial Cut Alignment in Canine Total Knee Replacement
3D-Printed, Patient-Specific Cutting Guides Improve Femoral and Tibial Cut Alignment in Canine Total Knee Replacement
DOI: 10.1111/vsu.13963
1
Department of Veterinary Medicine,
University of Cambridge, Cambridge, UK Abstract
2
Vet3D Ltd., Kendal, UK Objectives: The purpose of this cadaveric study was to determine whether
patient-specific guides (PSGs) improve the accuracy of tibial and femoral cut
Correspondence
alignment in canine total knee replacement (TKR), as compared with generic
Matthew J. Allen, Department of
Veterinary Medicine, University of cutting guides.
Cambridge, Madingley Road, Cambridge Study design: Original research.
CB3 0ES UK.
Email: [email protected]
Animals: Sixteen pelvic limbs from skeletally mature medium- to large-breed
canine cadavers.
Methods: Specimens were randomly allocated to one of two groups (PSG or
Generic; N = 8/group). In the Generic group, femoral and tibial ostectomies
were made using the standard canine TKR femoral cutting blocks and tibial
alignment guide. In the PSG group, the cuts were made using a series of cus-
tom 3D-printed cutting guides. “Planned” and “actual” tibial and femoral cut
alignments were compared in the frontal and sagittal planes, and errors were
calculated by subtracting actual from planned values.
Results: Use of 3D-printed PSGs improved tibial cut alignment in the frontal
plane but not the sagittal plane. PSGs also improved the alignment of the cra-
nial and distal femoral ostectomies but did not impact varus-valgus alignment.
Conclusions: These findings support the use of PSGs for TKR in dogs. Clinical
trials are now needed to determine whether the benefits of PSGs translate into
measurable improvements in joint function and implant longevity.
Clinical significance: PSGs have the potential to improve femoral and tibial
component alignment in canine TKR.
Abbreviations: 3D, 3-dimensional; CT, computed tomography; ETAG, extramedullary tibial alignment guide; FCB, femoral cutting block; PMMA,
polymethyl methacrylate; PSG, patient-specific guide; STL, Standard Tessellation Language; THR, total hip replacement; TKR, total knee
replacement.
Presented in part at the American College of Veterinary Surgeons Congress; October 12-15, 2022; Portland, Oregon.
674 © 2023 American College of Veterinary Surgeons. wileyonlinelibrary.com/journal/vsu Veterinary Surgery. 2023;52:674–685.
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FRACKA ET AL. 675
generic cutting blocks/guides. This is the same approach euthanatized for reasons unrelated to this study. The ani-
as is used in human TKR, but questions remain as to mals had been donated for use in teaching and research,
how accurate these generic TKR instruments are,2 partic- with the informed consent of the owners. The age and
ularly with respect to accurate alignment with the bodyweight of the cadavers were not recorded; however,
mechanical axes of the femur and tibia.3 It is widely rec- they were all above 20 kg (the minimum bodyweight for a
ognized in human TKR that component alignment is a TKR candidate at our institution) to be included in this
key determinant of long-term implant survival,4 and it study. The hindlimbs were disarticulated at the hip joint
has been reported that up to 22% of primary TKR cases and stored in sealed bags at 20 C until the study was con-
performed using standard instrumentation have axial ducted. Specimens were thawed for at least 24 h and
malalignment of greater than 3 degrees.5 Generic instru- allowed to equilibrate to room temperature prior to being
mentation is also more challenging to use in knees with used in the experiment. The specimens were randomly
deformities.5 allocated to one of two groups (PSG or Generic; N = 8/
There is growing interest in the use of patient-specific group).
guides (PSGs), designed from computed tomography
(CT) scans of the patient's anatomy. Proposed advantages
of PSGs include greater accuracy in the bone cuts, 2.1.1 | Preoperative planning and
reduced operative time and the ability to account for measurement of femoral and tibial cut
unique pathologies (especially deformity) that can com- alignment: Generic group
plicate the use of generic cutting guides.3,6 PSGs are
becoming more common in human orthopedics, includ- Orthogonal radiographs (full-length mediolateral and
ing TKR surgery. PSGs simplify pin placement and the caudocranial stifle series, plus a full-length caudocranial
creation of individualized bone cuts that correspond to view of the femur) were obtained to confirm skeletal
the patient's unique mechanical axis, in contrast with maturity, rule out the presence of pre-existing orthopedic
generic cutting guides that rely on average values for disease, and allow for surgical templating. A 25-mm cali-
determining the mechanical axes of the femur and tibia. bration ball was included in all radiographs for presurgi-
On the tibial side, PSGs can also avoid the need for place- cal templating. Femoral and tibial components of an
ment of an intramedullary alignment rod, making the appropriate size were positioned over caudocranial and
approach less invasive for the patient. mediolateral radiographs (Figure 1A,B). All radiographic
In veterinary medicine, the use of PSGs has garnered measurements were made with a commercial radio-
significant attention in the last few years, with potential graphic planning suite (vPOPPRO; Llangollen, UK) and
application in the correction of antebrachial growth measurements were performed by the same investigator
deformities,7–9 the drilling of transcondylar screws in to eliminate interobserver variability. The individual
humeral fractures and humeral intracondylar fissures,10 identities of specimens within the groups were coded but
atlanto-axial stabilization,11,12 pedicle screw placement,13 it was not possible to blind the observer to group alloca-
and femoral osteotomy.14 There have been isolated tion since the PSG measurements were made on CT
reports on the use of PSGs with custom canine and feline rather than plain radiographs (see later).
TKR implants,15,16 but their utility and accuracy have not Tibial cut alignment in the frontal plane was mea-
been evaluated in a systematic manner to date. We sured on caudocranial radiographs as the angle formed
hypothesized that PSGs would improve the surgeon's between the fixation surface of the tibial component and
accuracy in delivering the planned implant alignment in the mechanical axis of the tibia (formed by a line con-
TKR surgery. The objective of this canine cadaveric study necting the midpoint of the distal tibia and the intercon-
was therefore to determine whether the use of PSGs in dylar eminences on the proximal tibia) (Figure 1C). The
canine TKR increases the accuracy of femoral and tibial target frontal plane alignment was at 90 degrees to the
cut alignment, as compared with results obtained with mechanical axis.1 Sagittal cut alignment was measured
the use of generic cutting guides. on mediolateral radiographs as the angle between the fix-
ation surface of the tibial component and the tibial axis,
formed by a line connecting the midpoint of the talus dis-
2 | MATERIALS AND METHODS tally and the tibial intercondylar eminences proximally
(Figure 1D). The target sagittal cut alignment was with
2.1 | Cadaveric specimens 6 degrees of proximal tibial caudal slope, as per published
guidelines for canine TKR.1
Pelvic limbs were harvested from 16 skeletally mature Frontal plane alignment of the distal femoral cut was
medium- to large- mixed breed dogs that were determined as the angle formed between a line drawn
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676 FRACKA ET AL.
F I G U R E 1 Preoperative
planning for the Generic guide
group, showing optimized
positioning of the femoral and
tibial components on
preoperative caudocranial
(A) and mediolateral
(B) radiographs in vPOPPRO
planning software. Frontal plane
alignment of the tibial cut was
determined on the caudocranial
view by reference to the
mechanical axis of the tibia
(C) and sagittal plane alignment
of tibial cut was determined
from the mediolateral view as
the angle between the relevant
fixation surface and the axis of
the bone (D). The angles that
were measured are indicated
with orange semi-circles.
along the distal articular surface of the femoral compo- and distal femoral cuts was determined by measuring the
nent (line 5 in Figure 2A), and a line representing the angle formed between the anatomical axis in the sagittal
anatomical axis of the femur (line 1 in Figure 2A). The plane (line 1 in Figure 2B, defined using the interactive
anatomical axis was determined with an interactive mea- tool, as above), and lines drawn along the inside of the
suring tool (“anatomic axis”) within the vPOPPRO suite, relevant fixation surface of the femoral component (lines
which connects the midpoints of the femur at 25 and 50% 2 and 3 in Figure 2B). The third and final sagittal plane
of femoral length. Sagittal plane alignment of the cranial measurement was the closing angle for the femoral
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FRACKA ET AL. 677
reamer to provide space for the tibial keel and surrounding Mediolateral and caudocranial radiographs were obtained
bone cement mantle. The trial components were then post-operatively for each specimen. The cemented tibial
removed, and the bone beds cleaned and flushed. Poly- component was left in place for radiography. Tibial cut
methyl methacrylate (PMMA) bone cement (Teknivet; Bio- alignment was determined in both the frontal plane and
Medtrix LLC, Whippany, New Jersey) was injected into the sagittal plane (Figure 6A,B), as described previously, using
tibial keel hole and applied to the undersurface of an appro- the ostectomized surface of the proximal tibia as the refer-
priately sized 3D-printed plastic tibial component that con- ence surface.
tained an internal wire marker to allow for visualization on One the femoral side, the femoral component was
postoperative radiographs. When the cement in the tibia removed from the bone prior to imaging to improve the
had cured, an appropriately sized cementless cobalt- visualization of the cut surfaces. Cut alignment was deter-
chromium femoral component was impacted on the distal mined using the same approach as described for preopera-
femur. The patella was reduced, and stifle joint was again tive measurement in the Generic group, resulting in
evaluated for laxity, implant stability and range of motion. angular measurements for the following cuts: frontal plane
The joint was closed routinely. alignment of the distal femoral cut (Figure 7A), and sagit-
tal plane alignment of the cranial cut (Figures 7B) and dis-
tal femoral cut (Figure 7C). The locking angle was
2.3 | Surgical procedure for the PSG measured (Figure 7D) and the fit of the femoral compo-
group nent on the cut distal femur was estimated by comparing
the cranial-caudal width of the cut femur against the inter-
The surgical approach in the PSG group was the same as nal cranial-caudal dimensions of the femoral component.
for the Generic group, with a medial parapatellar skin Tibial and femoral measurements were performed by the
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680 FRACKA ET AL.
same investigator to eliminate interobserver variability. 2.5 | Data handling and statistical
The individual identities of specimens within the groups analysis
were coded to remove identifying information.
Errors in tibial and femoral cut alignment (in degrees)
were calculated by subtracting the measured (“actual”)
values obtained postoperatively from the values mea-
sured during the planning process (“planned”). Error
values were normally distributed and comparisons
between the two groups were made using an unpaired
Student's t-test with significance set at p < .05.
Fit of the femoral component was determined by
calculating the difference (in millimeters) between the
cranial-caudal width of the cut femur and the cranial-
caudal inner dimensions of the femoral component.
Data from the two groups were compared using an
unpaired Student's t-test, with significance set
at p < .05.
3 | RESULTS
F I G U R E 6 Measurement of postoperative tibial component
alignment was performed using the same approach as for the There were no significant technical problems with using
preoperative measurements. Frontal plane (varus-valgus) (A) and the PSGs. Use of the five sequential femoral guides was
sagittal plane (tibial slope) (B) were measured for each specimen. straightforward. As seen in Figure 5A–D, the guides fit
Angles are highlighted by black quarter-circles. very well onto the surface of the bone, allowing for a
F I G U R E 7 Measurement of
postoperative femoral alignment.
Frontal plane alignment was
determined relative to the
anatomical axis of the femur (A).
Sagittal plane measurements
included alignment of the cranial
ostectomy (B), distal ostectomy
(C) and the closing angle (D). Angles
are highlighted by white quarter-
circles.
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FRACKA ET AL. 681
F I G U R E 8 Tibial component alignment in canine total knee replacement (TKR) performed with generic or patient-specific guides
(PSGs). (A) The use of PSGs was associated with a statistically significant reduction in alignment error in the frontal plane (varus-valgus
alignment). (B) Sagittal plane alignment was similar in the two groups. The red line represents 3-degree threshold for axial malalignment.5
Numbers above bars represent p-values (ns, not significantly different).
precise and definitive fit. Their lower profile and trans- not associated with any difference in varus-valgus align-
parency allow greater visibility of the femur or tibia, at ment of the distal cut (3.02 ± 2.14 vs. 2.44 ± 1.67 for
least as compared with the bulkier generic guides. None the Generic and PSG groups, respectively; 95% CI: 2.65
of the guides loosened during the cutting procedure, to 1.47, p = .533) (Figure 9A). In contrast, sagittal plane
something that has been an issue in clinical cases oper- alignment of both the distal cut (5.93 ± 3.33 vs. 2.3
ated with the generic guides. ± 1.89 for the Generic and PSG groups, respectively;
95% CI 6.53 to 0.72; p = .018) (Figure 9B) and the
cranial cut (6.34 ± 4.53 vs. 2.5 ± 1.82 for the Generic
3.1 | Tibial component alignment and PSG groups, respectively; 95% CI: 7.539 to 0.1357,
p = .043) (Figure 9C) were significantly improved by the
Comparisons of the alignment data revealed a statistically use of PSGs. There was no statistically significant differ-
significant reduction in frontal plane alignment error in ence between the accuracy of closing angle cuts in the
the PSG group (2.41 ± 1.40 vs. 1.03 ± 0.96 ) for the two groups (3.75 ± 2.01 vs 3.59 ± 1.92 for the Generic
Generic and PSG groups, respectively; 95% CI: 2.674 to and PSG groups, respectively; 95% CI: 2.269 to 1.944)
0.1011 ( p = .036) (Figure 8A). In humans, optimal tib- (p = .871) (Figure 9D). The fit of the femoral component
ial component alignment is within 3 degrees of neutral;17 on the distal femur was also not different, with mean (±
as shown in Figure 8A, none of the PSG knees fell out- SD) under-sizing of the cranial-caudal femoral bone stock
side 3 degrees, compared with two of eight knees in the by 0.34 ± 0.38 mm for the PSG group and 0.4 ± 0.25 mm
Generic group. for the generic guides (p = .68).
There was no significant difference between PSG and
Generic groups for sagittal slope (1.60 ± 1.17 vs. 1.13
± 0.85 for the Generic and PSG groups, respectively; 4 | DISCUSSION
95% CI: 1.573 to 0.6229, p = .37) (Figure 8B).
The results from this study support the utility of PSGs for
improving the accuracy of sagittal alignment of the femo-
3.2 | Femoral component alignment ral cuts and frontal plane alignment of the tibial cut in
canine TKR. PSGs did not improve femoral alignment in
A total of four measurements were made to assess the the frontal plane when compared to generic cutting
accuracy of the femoral ostectomies. The use of PSGs was blocks, but this was in normal rather than pathological
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682 FRACKA ET AL.
F I G U R E 9 Femoral
component alignment in canine
total knee replacement (TKR)
performed with generic or
patient-specific guides (PSGs).
(A) In the frontal plane, varus-
valgus alignment of the femoral
component was similar in the
two groups. In the sagittal plane,
statistically significant
improvements in femoral
component alignment were seen
for the distal cut (B) and the
cranial cut (C). The closing
angle, important for ensuring a
locking fit for the femoral
component, was similar in the
two groups (D). The numbers
above bars represent p-values
(ns, not significantly different).
joints. PSGs were as effective as generic guides at preserv- commercial veterinary navigation system on the market,
ing the cranial-caudal width and the 10-degree locking these benefits cannot be realized at present. However,
angle at the distal femur, both of which are likely to be most veterinary referral centers have easy access to CT
important determinants of early mechanical stability in a scanning, and the clinical success of PSGs in other areas
press-fit femoral component. Our findings are consistent of veterinary orthopedics, including spine surgery and
with those from similar studies in human TKR, which long bone deformity correction,6–14 provides a strong
also demonstrated improved alignment with the use of rationale for exploring their utility in canine TKR. In this
PSGs.3,5,18,19 study, all the knees operated with the assistance of PSGs
In human TKR, frontal plane alignment of the tibial fell within 3 degrees of neutral in the frontal plane.
component is a key determinant of long-term implant There is a learning curve for any surgical procedure,
survival.4 It has been suggested that restoring the and total joint replacement is no exception. In the human
mechanical axis to within 3 degrees of neutral in the field, it has been estimated that the learning curve for
frontal plane is associated with a better long-term THR is 50 cases, while for TKR surgeons need around
outcome,17,20 and this has driven interest in the use of 80 cases for technical proficiency.24 Careful preparation
assistive technologies such as surgical navigation21,22 and and attention to detail is crucial to avoid complications
PSGs to optimize tibial component alignment. We have and errors that may lead to ligament damage or instabil-
previously reported that surgical navigation improves tib- ity, loosening of the implant and pain.4,14,15 In our experi-
ial component alignment in canine TKR,23 but without a ence, the tibial and femoral ostectomies are the most
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FRACKA ET AL. 683
technically challenging aspects of TKR surgery, and inac- based on case requirements or even surgeon preference,
curate cutting of the articular surfaces may contribute to is facilitated by the custom nature of the PSGs.
errors in tibial and femoral component position- The use of PSGs is not without drawbacks. Placement
ing.3,5,17,25,26 By virtue of their use of the patient's own of the PSG does require additional dissection on the cra-
anatomy as the reference, PSGs are likely to be much nial and medial surfaces of the femur (proximal to the
better guides for aligning the tibial and femoral osteo- trochlea, to seat the initial femoral guide) and a slightly
tomies. From a practical point of view, our data indicate more extensive dissection over the distal part of the tibial
that PSGs use in TKR is effective, feasible and may be crest to allow the tibial guide to seat properly under the
particularly helpful for surgeons with limited prior expe- crest. CT scans are needed for surgical planning and
rience with TKR surgery. Tibial and femoral PSGs are guide design; these scans, and the costs associated with
easy and quick to apply, require less manipulation during manufacture of the PSGs, must then be factored into the
surgery than conventional cutting blocks, and allow bet- overall cost of the procedure. Additionally, CT scans do
ter visualization of the anatomy following placement. Pin not provide any information about soft tissue laxity or
loosening, which is recognized as a problem when balancing, both of which are key determinants of success
generic guides are used, was not see in any of the PSG in TKR surgery. Surgeons undertaking TKR must still be
cases from this study; this likely reflects the fact that the trained in the fundamental principles of flexion/
same two pins are required to resist the forces experi- extension gap balancing and management of periarticular
enced during all four of the femoral cuts. Additionally, as soft tissues. It may be advantageous to consider designing
more and more bone is resected from the femur, the bone more than one tibial PSG, in the event that the initial cut
support available to the guide decreases, with a concomi- is not deep enough to allow for equal tension in flexion
tant increase in load transfer through the pins them- and extension. More work, much of it feasible in
selves. The fact that each of the PSGs is used for a single cadavers, will be needed to define the best approach to
cut, with full bone support, may well make these pins optimizing joint laxity in clinical cases.
less prone to loosening. Additional clinical experience In general, data for tibial cut alignment fell within a
will be needed to confirm the significance of this clinically acceptable range of 3 degrees of error
observation. (Figure 8A,B), but more extreme values were noted for
For surgeons doing only a few TKR cases in a year, two of the 16 specimens (12%). In human studies, outliers
the use of PSGs offers a very cost-effective alternative to (>3 ) have been reported in 11.1% of patients undergoing
investing capital in the purchase of a complete set of conventional TKR, but in only 4% in patients undergoing
generic TKR instruments. Moreover, many of the dogs navigated TKR.28 In the present study, possible reasons
that present for TKR have end-stage disease and varying for the presence of outliers include errors in preoperative
degrees of bone deformity and joint collapse that can planning or, more likely suboptimal application of the
complicate the use of generic cutting guides.27 PSGs offer PSG to the bone surface, leading to inaccurate cut posi-
a very attractive solution for these cases; however, pro- tioning and/or trajectory.29 As experience with PSGs
spective clinical studies are now needed to better define increases, it should be possible to define the most appro-
the value of PSGs, and to determine the impact of better priate locations for positioning PSGs directly against the
alignment on clinical function and implant survival in bone surface. In a clinical setting, it will also be very
canine TKR. Additionally, further studies may give important to ensure that the positioning of PSGs in not
insights into potential design improvements of the PSGs hindered by the presence of thickened periarticular soft
which could further enhance their efficacy. Although the tissues (e.g., medial buttress) or marginal osteophytes.
accuracy of guides with very similar trochlear contact The custom instrumentation used in this study was
footprints and guide plane dimensions has been previ- designed specifically for these cadaveric specimens. STL
ously demonstrated for distal femoral osteotomy,13 design models of the definitive commercial femoral and tibial
modifications such as the use of combined guides for >1 components were used in the planning steps to ensure
osteotomy, or slotted guides, may prove beneficial. Slot- accurate alignment of the femoral and tibial cuts. The
ted guides are used commonly in human TKR PSGs but use of STLs of CAD files is recommended as inaccuracies
may have drawbacks in smaller veterinary patients, most in implant sizing could result in clinically significant
notably the reduced visibility of the saw blade in the errors in the positioning and alignment of the bone cuts,
vicinity of the collateral ligaments and constrained angle leading to suboptimal component alignment and/or
of attack of the blade. Additionally, for optimal accuracy, stability.
the thickness of the blade that will be used must be As with any cadaveric project, there were a number
planned for in every case. The ability to easily trial guide of limitations in this study. These included the relatively
design variations, and indeed to create different designs small number of specimens operated within each group,
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684 FRACKA ET AL.
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