01 Myncke
01 Myncke
01 Myncke
From the Department of Orthopaedic and Trauma Surgery, Universitair Ziekenhuis Brussel (UZ Brussel)
On the other hand, they provide good long-term developed to restore hip biomechanics and achieve
results once osteointegrated and are easy to use primary implant stability, even in extreme cases.
when defects are limited (4,23). When bone stock Implant stability is favored by maximizing host
is insufficient, especially in superiorly, a high hip bone contact and by three flanges that fit the iliac,
rotation center can be an option. However, abductor ischial and pubic bone. The custom made central
muscle tension and leg length should be restored by hemispherical cup allows optimizing the position
inserting the stem in a prone position (6,16,25). of the hip rotation center. A polyethylene liner can
Cages and rings are often used in combination either be cemented or locked within the implant
with impaction bone grafting. They can be positioned (3,5,7,9,15,17,24,26).
to maximize implant stability, independently from One of the CTACs available in Belgian is the
the cup orientation. In a second stage, a cemented aMace® Acetabular Revision System (Mobelife,
all-poly or dual mobility cup allows optimizing cup Materialise, Leuven, Belgium). Like other CTACs,
positioning. This versatility is a major advantage in the design of aMace® implants is based on 3D models
the presence of large rim defects. Moreover, cages produced from CT scans. First, the patient-specific
allow bone stock restoration but require a minimum bony situation is evaluated and an implant proposal
of host bone contact and are mainly applicable is formulated including a biomechanical assessment,
in contained defects without large structural i.e. the cup anteversion and inclination angles,
deficiencies (13,18,22,23). the position of the rotation center and an analysis
Augments and structural allografts can provide of the bone stresses generated by the implant (12).
good structural support even in the presence of large The implant proposal also includes patient-specific
non-contained defects of both columns. However, screw positions based on bone quality and drill
augments do not restore bone stock and large guides to achieve the planned position. Moreover,
structural allografts may fail before osteointegration. and in contrast to other CTACs, the medial side of
Moreover, achieving primary implant stability in aMace® implants can be provided with a porous
the presence of large defects might be challenging defect-filling scaffold to favour osteointegration.
(4,10,19,20,23). In a second stage, surgeons and engineers come
Although most bone defects can be dealt with together to discuss surgical approach and implant
by “standard techniques”, large non-contained design issues. At this stage, each case is presented
defects extending in both columns and/or pelvic to Belgian health insurance companies to request
discontinuity remain problematic. Custom-made implant reimbursement. Additive manufacturing
triflanged acetabular components (CTAC) were techniques, i.e. 3D printing, are used to manufacture
A B C D
Fig. 1. — A : Preoperative situation after two revisions. B :Preoperative plan. C : Final implant. D : Postoperative situation..
an epoxy model of the hemipelvis, the triflanged cup surgeons were invited to participate and were asked
and the drill guides (11). Selective laser melting, in to complete a standardized survey and to provide
which a focused laser beam melts Titanium powder patients’ demographic and contact information.
layer-by-layer, is used to produce the final implant Standardized patient reviews were completed either
(Fig. 1). Sterilization of the models, the jigs and the during routine follow-up at the out-patient clinic or
implant is performed at the hospital (11). by phone.
This study investigates the initial experience The standardized surgeons’ survey questioned
with the aMace® system in Belgium. We report on the preoperative planning and reimbursement
the complexity of the preoperative planning and process. The surgeons were also asked to score the
reimbursement procedure, on the user-friendliness surgical procedure, i.e. the user-friendliness of the
of the system, the intraoperative problems, drill guides, the fitting of the component, agreement
complications and short-term results. between the trial implant and the final implant, and
agreement between the bone model and the actual
bone situation. Finally, the surgeons were asked to
MATERIALS AND METHODS grade the difficulty of the operation and to report
technical problems.
After approval by the ethical committee of the Postoperatively, patients’ outcomes were
UZ Brussel (B.U.N. 143201422977) (blinded), documen-ted with the Harris hip score (HHS) (14),
all patients treated in Belgium with the aMace® the Oxford hip score (8) and the Dutch Womac score
custom-made triflange acetabular component (2). Patients were also asked to report a general
between September 2009 and November 2014 satisfaction score between 0 and 10. Complications
were retrospectively identified by Mobelife. Only occurring during the whole follow-up period were
those patients receiving an aMace® implant as part reported by surgeons and patient-specific implant
of a revision THA were included. All operating proposals, were analyzed.
Table II. — Rating by the surgeon of the difficulty and time cases. Most alterations concerned the acetabular
taken for the reimbursement procedure.
center of rotation, but some cases required a smaller
Number of ischial flange or a more posterior position of the
Question cases (%)
iliac flange. All surgeons rated their influence on
[n=22]
Difficulty of the reimbursement procedure
the final implant as sufficient and appropriate. Four
Very easy 0 (0) surgeons needed to postpone the operation due to
Easy 0 (0) the preoperative planning procedures. But only
Normal 3 (13.6) 6/20 patients (30%) were unhappy with the surgical
Difficult 18 (81.8) delay.
Very difficult 1 (4.5) The total cost for the aMace© implant was a flat
Delay for reimbursement procedure
rate of 12 453.30 euro inclusive taxes. Till now,
No 0 (0)
Little 2 (9.1)
based on an individual analysis of the medical files,
Long 20 (90.9) Belgian health insurance companies provided full
Very long 0 (0) implant reimbursement in all cases.
Operation
Table III. — Rating by the surgeons of the difficulty of the
operation.
Number of cases (%) The mean surgical time was 241 minutes (SD:
[n=22] 81, range: 150-390 minutes). The difficulty of the
Very easy 1 (4.5) operation was rated as normal, easy or very easy
Easy 6 (27.3) in 16/22 cases (73%) (Table III). The ‘overall
Normal 9 (40.9)
experience’ with the aMace® implant was good but
with a large variation in the surgeons’ scores (mean
Difficult 3 (13.6)
score 8.1/10, range 2-10). Three different surgeons
Very difficult 3 (13.6)
were dissatisfied with the final implant during
surgery (3/22 cases) and answered ≤5/10 on at least
surgeon’s request, a 3D printed bone model and three out of the six questions reported in Figure 3.
triflanged component was produced. If the surgeon Technical problems occurred in 9/22 cases
agreed on the proposed solution, a finite element (41%), in 4/22 cases multiple technical problems
analysis model was constructed to evaluate the occurred during the same operation. However, the
strength of the triflanged cup and a report was sent to aMace® component could always be implanted
the insurance company for approval. If the surgeon and was never abandoned intraoperatively. The
did not agree with the first draft, a modified report most challenging problems occurred during the
and/or model was produced until an agreement was fitting of the implant in the acetabular defect.
reached. On the surgeon’s request, a 3D printed bone Mostly osteophytes and overhanging bone had to
model and triflanged component was produced. be removed as mentioned in the patient-specific
In total 13 surgeons reviewed the preoperative documentation. Surgeons were provided with both,
planning procedures for 22 cases. The mean time a plastic bone model including the amount of bone
between the decision to use an aMace® implant and to be removed as well as a plastic trial implant.
the operation was 4.26 months (range: 1-9 months). However, removing the exact amount of bone was
One reasons for this delay was the reimbursement difficult in four cases, and in two of these cases an
procedure, which most surgeons rated as time- unforeseen pelvic discontinuity or fracture occurred.
consuming and difficult (Table II). In 10 patients, This prevented exact fitting of the implant and both
CT data did not suitable for pre-operative 3D parts of the pelvis had to be reduced on the implant
planning, and a new CT scan was required. In some itself. As such, the continuity of both, the anterior
cases, surgeon-manufacturer interactions were time and posterior column was achieved with the implant
consuming and the draft was modified in 18/22 as an internal fixation device.
Fig. 4. — Mean postoperative patient scores with minimum and maximum (HHS: Haris Hip Score; OHS:
Oxford Hip Score)
Minor problems occurred with the drill guide Table IV. — Postoperative complications.
in 5/22 cases (23%). One of these cases was due Complication Number of cases (%) [n=22]
to the poor fitting of the implant. In two cases, a Dislocation 4 (18.2)
combination of smaller drill guides, instead of Infection 1 (4.5)
a single, large guide, would have facilitated the Loosening 0 (0.0)
procedure. Subsequently Mobelife provided these Re-revision 0 (0)
separated guides routinely. In the other two cases,
Other 3 (13.6)
soft tissue prevented the use of some of the drill
guides and the surgeon drilled free-handed or had suppression. Other complications included one
to mobilize more soft tissues to fit the guides. Also, large hematoma, one sciatic nerve palsy with little
during one operation, retained broken screws could recovery after three years, and one case of ischial
not be removed and prevented the insertion of some screw loosening after six months in a patient with
of the new screws. pelvic instability. At the latest follow-up, no patients
Despite some difficulties, all surgeons would had clear radiographic signs of implant loosening.
consider using the aMace® implant again in a similar
case. However, in 4/22 cases the surgeon was not DISCUSSION
convinced that the aMace® implant was superior to
other solutions. In one case the need for a custom- Reconstruction of massive periacetabular bone
made implant was questioned as the defect was less defects requires implant stability, restoration of hip
severe than expected. In another case, the surgeon biomechanics and if possible improvement of bone
thought another cup could have been implanted stock for future revisions. Custom-made triflanged
trough a smaller approach. In a third case, the acetabular components (CTAC) offer implant
implant lacked primary stability due to suboptimal stability through structural support and through
fitting. In the last case, no specific reason was given. screw fixation in the ileum, ischium and pubis. This
combined with the possibility to plan accurately the
Functional outcome cup orientation and the hip rotation center (1), opens
up new perspectives in difficult cases. This study
Functional postoperative scores were obtained describes the early Belgian experience with aMace©
in 20 patients. According to the Womac score, 8/20 implants by Mobelife, inserted between September
patients showed no pain, 7/20 reported no stiffness 2009 and November 2014.
and one patient had a completely normal physical Overall, the planning and reimbursement pro-
function (Figure 4). The patients’ satisfaction score cedure was experienced as cumbersome and time
improved from 2.44/10 (range 0-8) to 8.53/10 consuming. The overall surgical experience was
(range 5-10). All but one patient would go for the positive despite some issues of implant fitting in
same operation again if needed. cases of pelvic discontinuity or when significant
amounts of bone needed to be removed. As expected,
Complications the complication rate was relatively high and
involved mainly dislocations. Nevertheless, taking
Surgeons reported an overall complication into account the severity of the cases, short-term
rate of 36% (8/22 cases) (Table IV). Dislocation clinical outcome was satisfactory in most cases.
was the most frequent complication, but all cases
were successfully treated by closed reduction. One Planning and cost
infection was diagnosed 3.5 years after the revision
operation, when a fistula appeared. The germ was Till now, eight other studies (3,5,7,9,15,17,24,26)
the same as the one found during implantation. describes results of CTAC (Table V). As in our
Apart from the fistula, the patient had no particular study, most papers (5,9,15,24) report the preoperative
complaints and was treated by lifelong antibiotic planning to be complex and time consuming.
Moreover, surgeons see the need for a standardized perceived the fact that the implant could not be
preoperative CT scanner, the lack of bone stock modified during surgery as a general drawback.
restoration, the high cost of the implant as well In our study, lack of fitting during surgery due
as the working time for surgeons/staff, as major to of pelvic discontinuity or inadequate bone
disadvantages (5,9,15,24). removal was the major problem. In case of pelvic
The cost of the aMace® implant in Belgium discontinuity, the implant could be used to reduce
is at the higher end compared to other implants and fix both parts of the pelvis but that strategy led
(€12 453.30 versus $5200 to $12 500) (5,9,15,24). to ischial screw migration in one case. To avoid this,
Till now, all aMace® implants have been reimbursed cement augmentation of the ischial screws has been
by the publicly funded Belgian health care system suggested (9,15). Previous studies also advocated
based on case-by-case scrutiny. However, without fixing the ischial screws first and reducing the
evidence that this approach is superior to cheaper discontinuity by bringing the component into close
alternatives, full reimbursement could be jeopardized contact with the host bone (5,9,24). An alternative
in the future. On the other hand, if good clinical is additional column plating but if performed prior
outcomes and/or lower needs for re-revision can be to inserting the CTAC, this could compromise an
demonstrated, the balance on the long-term could adequate fit.
be favorable. As such, we believe that expensive
CTAC implants should only be considered in those Complications
extreme cases where no other solution is adequate
on the short- or medium-term. In all other cases, As expected for this type of surgery, the number
less expensive solutions with more possibilities for of complications reported in literature is high
bone stock restoration should be favored. (overall, including this study: 74/282 cases, 26%).
In our study, the complication rate (36%) was
Surgery comparable (9,15,24) or higher (3,7,17,26) than in
other series (Table V). Despite the possibility to
Overall, the operation either went smoothly restore hip biomechanics accurately (1), dislocations
and surgeons were happy with the implant and the (overall, including this study: 39/242 cases, 14%)
instrumentation or, technical problems occurred and remain the major problem (3,7,5,9,15,17,24,26). This
the procedure became troublesome and, took much could to be due to the extensive approach and the
more time and effort to be completed. Specific poor quality of the soft tissues in multioperated
surgical problems were not reported in most other patients. Although some authors advocate the use of
series. However, we and others (5,9,15,17,24,26) constrained liners (5,17,24), we would suggest using
cemented dual mobility cups whenever possible to IIIA, IIIB and pelvic discontinuity) could shorten
limit the strains on the bone-implant interface. the surgical delay and avoid cumbersome case-by-
On the short-term we report screw migration in case approvals. From the insurance perspective it
one case and one infection, but none of the implants could also limit the use of an expensive technique
was grossly loose. Till now, none of these cases was when other cheaper alternatives are adequate.
revised, but they both are at risk. These findings Despite plastic models, removing selected parts
are in line with other studies, the overall published of periacetabular bone was problematic in some
revision rate including this study being 18% cases. As such, the amount of bone to be removed
(50/282 cases) (3,7,5,9,15,17,24,26). However, these should be limited to the strict minimum to facilitate
figures need to be seen in the light of the difficulties proper implant fitting.
to revise large acetabular components, making these To restore bone stock for future revisions, bone
interventions particularly risky and unpopular. grafting between the implant and host bone should
be considered. For this, the implant should not aim
Patient function to achieve full contact with the host bone, but only
Patient satisfaction after revision with CTAC sufficient contact for structural support and implant
implants has not been reported before in literature. stability. In those areas without direct host bone
In our study, patient satisfaction was high, mainly contact, room could be left for impaction bone
because of pain reduction and improved walking grafting of cavitational defects.
ability. However, multiple revisions leading to As screw fixation could be problematic in poor
extensive soft tissue damage and massive bone quality bone and because full bone-implant contact
destruction prevented excellent results in most could not always be achieved, locking screws in the
cases. flanges should be considered. This could prevent
screw migration and improve fixation especially in
Limitations of the study cases of pelvic discontinuity.
As this was a retrospective study we miss
CONCLUSION
preoperative data. Nevertheless, most surgeons
kept good records of these rare cases and patients
This study showed that, at least on the short-term,
were reviewed personally by one of the authors.
custom-made triflanged acetabular components as
Additionally, despite efforts to collect data from
the aMace® implant, provided adequate fixation
all revision patients operated on with an aMace®
and acceptable clinical results with a high degree
implant in Belgium, only 13/20 surgeons (65%)
of patient satisfaction in complex revisions. Despite
were willing to participate and 21/51patients (43%)
a high complication rate, the use of such implant
were reviewed. This seems inevitable when multiple
seems justified in carefully selected patients with
centers are allowed to try out new techniques
massive uncontained acetabular bone defects. Due
outside a global prospective study protocol. On the
to the high cost we would advise there use only in
other hand, this is the largest series reporting on a
those cases where no good clinical results can be
country’s initial experience with CTAC implants.
expected with other treatment options, i.e. Paprosky
As aMace® implants have been available only
type IIIA, IIIB and pelvic discontinuity. Further
recently, follow-up is limited to less than five years.
improvement of the system with the use of locking
Finally, due to the large heterogeneity of published
screws and the combination with graft impaction
series it is difficult to compare our results with those
techniques should be investigated.
of other CTAC studies or other techniques.
Acknowledgement
Future perspectives
The authors thank Mobelife for their help in identifying
Providing an easier standardized reimbursement Belgian surgeons using their implants and providing access
procedure for selected indications (e.g. Paprosky type to patient-specific documentation. This study was financed by
the UZ Brussel (B.U.N. 143201422977) (blinded). None of the 13. Hansen E, Shearer D, Ries MD. Does a cemented cage
authors received benefits related to this study. improve revision THA for severe acetabular defects? Clin
Orthop Relat Res 2011 ; 469 : 494-502.
REFERENCES 14. Harris WH. Traumatic arthritis of the hip after dislocation
and acetabular fractures: treatment by mold arthroplasty. An
end-result study using a new method of result evaluation. J
1. Baauw M, van Hellemondt GG, van Hooff ML, Spruit
Bone Joint Surg Am. 1969 ; 51 : 737-755.
M. The accuracy of positioning of a custom-made implant
15. Holt GE, Dennis DA. Use of custom triflanged acetabular
within a large acetabular defect at revision arthroplasty of
components in revision total hip arthroplasty. Clin Orthop
the hip. Bone Joint J 2015 ; 97-B : 780-785.
Relat Res 2004 ; 429 : 209-214.
2. Bellamy N, Buchanan WW, Goldsmith CH, Campbell
16. Issack PS, Nousiainen M, Beksac B, Helfet DL, Sculco
J, Still LW. Validation study of WOMAC: A health status
TP, Buly RL. Acetabular component revision in total hip
instrument for measuring clinically important patient
arthroplasty. Part I: cementless shells. Am J Orthop 2009 ;
relevant outcomes to antirheumatic drug therapy in patients
38 : 509-514.
with osteoarthritis of the hip or knee. J Rheumatol 1988 ;
17. Joshi AB, Lee J, Christensen C. Results for a custom
15 : 1833-1840.
acetabular component for acetabular deficiency. J
3. Berasi CC, Berend KR, Adams JB, Ruh EL, Lombardi
Arthroplasty 2002 ; 17 : 643-648.
AV. Are custom triflange acetabular components effective
18. Leopold SS, Jacobs JJ, Rosenberg AG. Cancellous
for reconstruction of catastrophic bone loss? Clin Orthop
allograft in revision total hip arthroplasty. A clinical review.
Relat Res 2015 ; 473 : 528-535.
Clin Orthop Relat Res 2000 ; 371 : 86-97.
4. Brubaker SM, Brown TE, Manaswi A, et al. Treatment
19. Mankin HJ, Gebhardt MC, Jennings LC, Springfield DS,
options and allograft use in revision total hip arthroplasty
Tomford WW. Long-term results of allograft replacement
the acetabulum. J Arthroplasty 2007 ; 22 : 52-56.
in the management of bone tumors. Clin Orthop Relat Res
5. Christie MJ, Barrington SA, Brinson MF, Ruhling ME,
1996 ; 324 : 86-97.
DeBoer DK. Bridging massive acetabular defects with the
20. Nehme A, Lewallen DG, Hanssen AD. Modular porous
triflange Cup: 2- to 9-year results. Clin Orthop Relat Res
metal augments for treatment of severe acetabular bone
2001 ; 393 : 216-227.
loss during revision hip arthroplasty. Clin Orthop Relat Res
6. Christodoulou NA, Dialetis KP, Christodoulou AN.
2004 ; 429 : 201-208.
High hip center technique using a biconical threaded
21. Paprosky WG, Perona PG, Lawrence JM. Acetabular
Zweymüller® cup in osteoarthritis secondary to congenital
defect classification and surgical reconstruction in revision
hip disease. Clin Orthop Relat Res 2010 ; 468: 1912-1919.
arthroplasty. J Arthroplasty 1994 ; 9 : 33-44.
7. Colen S, Harake R, De Haan J, Mulier M. A modified
22. Schreurs BW, Bolder SB, Gardeniers JW, Verdonschot
custom-made triflanged acetabular reconstruction ring
N, Slooff TJ, Veth RP. Acetabular revision with impacted
(MCTARR) for revision hip arthroplasty with severe
morsellised cancellous bone grafting and a cemented cup.
acetabular defects. Acta Orthop. Belg 2013 ; 79 : 71-75.
A 15- to 20-year follow-up. J Bone Joint Surg Br 2004; 86 :
8. Dawson J, Fitzpatrick R, Carr A, Murray D.
492-497.
Questionnaire on the perceptions of patients about total hip
23. Sheth NP, Nelson CL, Springer BD, Fehring TK,
replacement. J Bone Joint Surg Br 1996 ; 78: 185-90.
Paprosky WG. Acetabular bone loss in revision total
9. DeBoer DK, Christie MJ, Brinson MF, Morrison JC.
hip arthroplasty: evaluation and management. J Am Acad
Revision total hip arthroplasty for pelvic discontinuity. J
Orthop Surg 2013 ; 21: 128-139.
Bone Joint Surg Am 2007 ; 89: 835-40.
24. Taunton MJ, Fehring TK, Edwards P, Bernasek T, Holt
10. Dewal H, Chen F, Su E, Di Cesare PE. Use of structural
GE, Christie MJ. Pelvic discontinuity treated with custom
bone graft with cementless acetabular cups in total hip
triflange component: a reliable option. Clin Orthop Relat
arthroplasty. J Arthroplasty 2003 ; 18: 23-28.
Res 2012 ; 470 : 428-434.
11. Gelaude F. A niche application, in need of a (custom)
25. Von Roth P, Abdel MP, Harmsen WS, Berry DJ.
solution, that is adequate and easy-to-obtain. Mobelife
Uncemented jumbo cups for revision total hip arthroplasty :
2011.
12. Gelaude F, Clijmans T, Delport H. Quantitative a concise follow-up, at a mean of twenty years, of a previous
computerized assessment of the degree of acetabular bone report. J Bone Joint Surg Am 2015 ; 97: 284-287.
deficiency: Total radial Acetabular Bone Loss (TrABL). 26. Wind MA, Swank ML, Sorger JI. Short-term results
Advances in Orthopedics, vol. 2011, Article ID 494382, 12 of a custom triflange acetabular component for massive
pages, 2011. doi:10.4061/2011/494382 acetabular bone loss in revision THA. Orthopedics 2013 ;
36 : 260-265.