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Injury, Int. J.

Care Injured 34 (2003) S-B55S-B62

TomoFix: a new LCP-concept for open wedge osteotomy


of the medial proximal tibia early results in 92 cases
Alex E. Staubli1, Carlo De Simoni2, Reto Babst3, Philipp Lobenhoffer4
1
2
3
4

Department of Orthopaedics, Kantonsspital Luzern, Luzern, Switzerland


Orthozentrum Klinik St. Anna, Luzern, Switzerland
Department of Trauma Surgery, Kantonsspital Luzern, Luzern, Switzerland
Department of Trauma and Reconstructive Surgery, Henriettenstiftung Hannover Marienstrasse, Hannover,
Germany

Summary1
High Tibial Osteotomy (HTO) is an established treatment for unicompartmental osteoarthritis of the knee
with malalignment. The classic procedure for correcting varus deformity is the lateral closed wedge
osteotomy of the tibia with osteotomy of the fibula. The
disadvantages of this technique are well known. Open
wedge osteotomy from the medial sideeliminates the
risk of compartment syndrome and peroneal nerve
injuries. A new fixation device (TomoFix) with an
adapted surgical technique allows stable fixation of the
osteotomy without the need to fill the osteotomy gap
with bone grafts.
In a prospective study, 92 consecutive cases were
treated with this procedure. Bony healing with remodelling of the medial and posterior cortical bone was
observed. Full weight-bearing was possible ten weeks
after surgery. There were no implant failures. Complications included one delayed union, two revarisations
and one deep infection.
Keywords: High Tibial Osteotomy (HTO), openwedge osteotomy, TomoFix plate, medial osteoarthritis, varus knee
Injury 2003, Vol. 34, Suppl. 2

Introduction
High Tibial osteotomy (HTO) is a common procedure
for managing medial osteoarthritis (OA) of the knee
1

Abstracts in German, French, Italian, Spanish, Japanese and


Russian are printed at the end of this supplement.

00201383/$ see front matter # 2003 Published by Elsevier Ltd.


doi:10.1016/j.injury.2003.09.025

with good results [5,6,11,12,13]. The long-term outcome


of HTO for medial OA depends on the correction
achieved after the osteotomy has healed [5,11,12,13].
The classic technique is the lateral closed wedge
osteotomy popularised by Coventry [4]. This procedure
has been performed with various fixation devices
[3,10,14,16,21] . Potential complications of this method
include neurovascular injury, compartment syndrome,
intra-articular fracture, infection, delayed union or nonunion, instability, recurrent varus deformity and valgus
overcorrection [4]. In addition, major corrections cause
an offset of the proximal tibia that may compromise
placement of the tibial component of a total knee arthroplasty.
Medial opening wedge osteotomy has the advantages
of maintaining the bone stock and correcting the deformity close to its origin, which may facilitate subsequent
arthroplasty [21]. Fibular osteotomy is not required and
the osteotomy is technically easier. This method is
presently most often performed with an external distraction and fixation device for several weeks. The principal disadvantage of this technique is pin-track infection, which may often require pin removal before correction and union are present and may possibly jeopardize subsequent arthroplasty [17]. Few reports exist
describing medial open wedge osteotomy using internal
plate fixation. Problems were mainly due to implant failure or loss of correction due to unstable implants. In addition, the need to harvest bicortical bone grafts from the
pelvic crest to fill the gap caused significant morbidity.
In an attempt to overcome the fixation problems, the
authors developed an internal fixator (TomoFix) that
is intended to hold the attained correction without addi-

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tional bone substitutes filling the osteotomy gap [7]. The
new TomoFix plate has been designed to achieve optimal stability without the interference of bone healing
and without any bone graft. The principle of the locking compression plate system (LCP) [8] meets our
requirements. The locking-head screws provide a stable
fixation without compression between plate and bone.
In a subsequent prospective study, we evaluated this
new device and asked whether the correction could be
maintained without bone substitution until bone healing is radiologically completed. The outcome was evaluated by clinical assessment and conventional radiography.

Materials and Methods


Inclusion criteria
Patients with varus malalignment of the leg and symptoms of overloading in the medial compartment of the
knee were included in this study. An intact lateral joint
compartment and intact soft-tissue covering of the
medial head of the tibia were further preconditions. The
range of motion of the knee-joint had to be at least
0/10/100 for extension / flexion.
Exclusion criteria
Patients with aseptic necrosis of the knee (Ahlbcks disease) or bone-healing disorders, patients over the age of

75 years and adolescents with radiologically open


growth plates were excluded.
Preoperative assessment and planning:
Clinical examination
The subjective pain intensity was determined by means
of a visual analogue scale (VAS) from 0 to 10 (0 = no pain,
10 = unbearable pain). The range of passive motion (flexion / extension) was measured with a goniometer.
The radiological documentation included standard
knee radiographs, a standing anteroposterior (AP) view
on a long cassette, a lateral view, a tunnel view and a
patella axial view in 45 flexion. If the clinical symptoms
were not conclusive, a technetium scintigraphy was performed to confirm the focal overloading in the medial
joint compartment. In patients with suspected additional
lesions of the knee joint, magnetic resonance imaging
was carried out to eventually plan further operations.
Preoperative planning:
For the preoperative planning (Fig. 1), we used an AP
long-leg weight-bearing radiograph. The amount of correction of the mechanical axis is guided by the stage of
degenerative changes in the medial joint compartment.
If relevant narrowing of the medial joint space was
shown on the radiograph, we carried out an overcorrection according to the work of Fujisawa [9]. The
weight-bearing line was shifted to a point 62% lateral
on the transverse diameter of the tibial plateau. If the
overloaded medial compartment was largely intact,
without narrowing of the joint space, we corrected the
axis to neutral with the postoperative weight-bearing
line passing the centre of the knee.
Operative technique [15]
The operation was performed under spinal or general
anaesthesia. Intravenous antibiotic and thromboembolic prophylaxis was used.
The patient was operated on in a supine position. The
leg was draped free, including the iliac crest, so as to be
able to check alignment intraoperatively, even under
image intensification. A sterile tourniquet was applied
on the thigh, which rested on a knee-bench to prevent
compression of the popliteal neurovascular structures.
A fluoroscope was installed, allowing visualisation of
the knee-joint in two planes.
Surgical procedure:

Fig. 1: Preoperative planning of the osteotomy. Overcorrection of the new mechanical axis according the work of Fujisawa (from AO folder p. 4).

To ensure an intact lateral joint compartment and to treat


additional intra-articular lesions, a knee arthroscopy
was first performed on every patient. Ventral osteophytes in particular were considered and resected to
achieve full extension.

Staubli et al.: TomoFix: a new LCP-concept

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Fig. 2: Skin incision 5 cm distal the joint line parallel to the


pes anserinus.

Fig. 4: Schematic drawing of the so called 3-chisel technique:


The osteotomy is opened by stepwise insertion of 3 chisels
in the osteotomy gap (from AO folder p. 7, fig. 5)

Fig. 3: Schematic drawing of the V-shaped osteotomy. The


first Osteotomy is performed distal the Kirschner wire, parallel to the tibial slope. The second frontal osteotomy starts
in the anterior one-third of the tibia angulated 135 and exits
proximal to the insertion of the patellar tendon (from AO
folder p. 7, fig. 4)

Injury 2003, Vol. 34, Suppl. 2

We used an oblique skin incision 5cm distal to the joint


line, parallel to the pes anserinus for exposure (Fig. 2).
Proximal to the pes anserinus, the medial collateral ligament was dissected off the posteromedial cortex of the
tibia and a blunt Hohmann retractor was inserted to protect the neurovascular structures. The direction of the
osteotomy in the frontal plane was marked with a 2.5mm threaded K-wire under fluoroscopic control. The
osteotomy started at the upper margin of the pes anserinus and ended 1 cm from the lateral cortical margin at
the level of the tip of the fibula. The osteotomy was performed in a V-shape, in two planes (Fig. 3). The first
osteotomy was performed distal to the K-wire, parallel
to the tibial slope. The second frontal osteotomy plane
started in the anterior one-third of the proximal tibia at
an angle of 135 to the first osteotomy plane. This
osteotomy exited the bone proximal to the insertion of
the patellar tendon (Fig. 3). The osteotomies were performed with the oscillating saw mediodorsally and
were completed with chisels. The osteotomy was
opened by stepwise insertion of three chisels to avoid
intra-articular fractures of the tibial-head fragment
(Fig. 4). The mechanical axis was then adjusted according to the preoperative planning and the correction
retained with a bone spreader (Fig. 9) that was inserted
into the dorsomedial osteotomy gap. If the medial ligamentous apparatus is under undue tension, we performed a soft-tissue release distally by further subperiosteal detachment of the long fibres of the medial col-

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Fig. 5: The plate is pretensioned by insertion of a temporary


lag screw distal to the osteotomy. This manoeuvre induces
compression on the lateral cortical hinge (from AO folder
p. 11, fig. top).

lateral ligament from the tibia. Full extension had to be


achieved and was of uppermost importance.
The anatomically pre-shaped plate was inserted into
a subcutaneous tunnel and centred on the anteromedial
plane of the tibia. Two spacer bolts were inserted in the
plate to maintain the distance between the plate and the
bone. The proximal fixation of the plate was carried out
with three locking head screws, which provided wide
support of the tibial plateau in the subcortical area. The
plate was then pretensioned by inserting a temporary
lag screw distal to the osteotomy. This manoeuvre
approximated the distal fragment to the plate and
induced compression on the lateral cortical hinge
(Fig. 5). For definitive fixation of the plate, the distal
locking head screws were inserted through a small incision. Finally, the lag screw was replaced by a locking
head screw (Fig. 6). To support haemostasis, after
removal of the tourniquet we applied a compression
bandage for eight minutes. As a rule, no drain was used.
If a drain was inserted, it was placed away from the
osteotomy gap and was without suction.
Postoperative management:
The day after operation the patient was mobilised with
partial weight-bearing (15-20 kg) of the operated leg,
depending on the pain level. Flexion and extension in
the knee-joint was exercised both actively and passively.
The patients left the hospital when they were able to
walk without assistance, using two crutches, and with
adequate wound healing.
Follow-up:
At follow-up visits, a clinical examination covered the
following parameters: pain intensity, range of passive
motion and resumption of full weight-bearing after
surgery. All findings were documented by an independent investigator.
Radiological evaluation:

Fig. 6: Postoperative ap radiography of a right knee of a patient


with varus osteoarthritis and
open wedge osteotomy performed with TomoFix plate.

The postoperative radiological and clinical follow-up


examinations were carried out after two days, six weeks,
twelve weeks, six months, twelve months and after
removal of the implant. At Week 6 and Week 12, an AP
weight-bearing radiograph was obtained with the kneejoint in extension on a long cassette.
Clinical and radiological examinations carried out
between the sixth month and the twelfth month and follow-up examinations over twelve months after the operation were divided into two examination-blocks of nine
months and 15 months after the operation, respectively.
A line-finder was used to determine the anatomical axes of the femur and the tibia and the femorotibial
angle on the AP radiograph. The tibial slope was defined
as the angle between the dorsal tibial cortex and the tib-

Staubli et al.: TomoFix: a new LCP-concept

Table 1: Using the visual analogue scale (VAS) from 0 to 10


(0=no pain, 10=unbearable pain) significant pain reduction
through follow up examinations was documented.

ial plateau in the lateral view. For determination of the


height of the patella, the Blackburne-Peel ratio [2] was
used on the lateral view.

Results
92 open-wedge HTOs, without bone substitute, were
carried out in our hospital on 90 consecutive patients
between May 2000 and May 2002. The operations were
performed by the authors. All patients had an arthroscopic evaluation of the joint status. In nine patients, an
anterior cruciate ligament (ACL) reconstruction was
performed at the same time as the HTO. Other concomitant procedures were: 72 patients with a partial
resection of the medial meniscus, six patients also had
a cartilage debridement and in one patient had a mosaicplasty. The mean correction was 9.2 degrees, with a standard deviation of 3.41 (range: 2 to 20 degrees). All
patients were followed until bony union of the
osteotomy had been radiologically documented.
During the follow-up period, from May 2000 to September 2002, 37 implants were removed, on average
twelve months (range: *2.5 to 17 months) after the operation. 25 of the 90 patients were women and 65 were
men. The mean age was 50 years, ranging from 18 to 75
years. The mean follow-up period was nine months
(range: 3-24 months).
Using the visual analogue scale (VAS), the patients
reported a significant subjective reduction of pain, from
a score of 4 (range: 3.5-5) before the operation to a score
of 2 (range: 1.5-3) after six and twelve weeks, and were
almost free of symptoms (scores of 1.5 to 0.5) under full
weight-bearing at the follow-up examinations (Table1).
Walking without crutches and full weight-bearing was
achieved after an average of ten weeks (range: 6-12
weeks).
At the first follow-up examinations, hyposensitivity
in the area of the cutaneus branch of the saphenous

Injury 2003, Vol. 34, Suppl. 2

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nerve (N. infrapatellaris) was observed in ten patients.
This complication was subsequently prevented by careful subcutaneous dissection. Other neurological complications were not seen.
In three patients, a knee arthroplasty was performed
because of progressive osteoarthritis and persistence of
the symptoms, and in a further two patients, a knee
arthroplasty was recommended. The range of passive
motion reached the baseline values, at the 12-week follow-up examination. Radiologically, consolidation is
evident with bone formation in the osteotomy gap and
variable formation of callus in the lateral and dorsal part
of the osteotomy (Fig. 7). Quantification of the bone formation was not possible on the basis of the conventional
radiographs because of projection artefacts and superposition of the implant.
The postoperatively achieved femorotibial axis
(Table2) and tibial slope was maintained during the
bony healing phase without statistically significant loss
of correction. In the early postoperative radiograph, the
femorotibial axis appears with a smaller valgus angle
(postoperative: 6.9) than in the subsequent follow-up
examinations (six weeks: 8.5). This difference arises
from the fact that the x-ray 1-2 days after the operation
was not taken in full extension and with full weightbearing. Rotational errors, which affect the femorotib-

Fig. 7: Ap radiography of a right knee 12 months postoperatively. Bony consolidation of the osteotomy gap with remodelling of the medial cortex is visible.

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Table 2: The femorotibial axis measured from ap radiographs through the follow up examinations are shown.
Mean values with standard deviation at the defined follow
up intervals are documented.

ial angle, can be identified in the AP image and largely


excluded by the centring the patella.
Postoperatively, the tibial slope showed a tendency to
increase in comparison to the preoperative value (mean
deviation: 0.99). The Blackburn-Peel ratio decreased,
due to the relative distalisation of the tibial tuberosity
from 0.82 before to 0.63 after the operation, and it
remained constant during the healing phase. During the
whole period of the study, no cases of implant failure
were reported. In two patients, both of whom were
heavy cigarette smokers, bony consolidation was
delayed (lateral bone resorption and delayed union in
the osteotomy gap) (Fig. 8). In one patient (male, 66
years) relevant loss of correction appeared in both knees.
In one female patient (insulin-dependent Type 1 diabetes mellitus) with simultaneous ACL reconstruction,
a local infection without joint involvement occurred.
After repeated debridement and early removal of the
implant (*2,5 months after the operation) the infection
was cured and the osteotomy healed, with a correction
loss of three degrees.

Discussion

Fig. 8: One case of a heavy cigarette smoker with delayed


union 6 months postoperatively. Dehiscence of the lateral
cortex and no consolidation of the osteotomy gap is shown.

The concept of angle-stable screw fixation within the


plate (LCP system) allows stable fixation of an
osteotomy even under weight-bearing. This concept has
been clinically proven in orthopaedic trauma surgery
using Point Contact Fixator (PC-Fix) in small diaphyseal bone, the less invasive stabilising system (LISS) for
periarticular fractures around the knee and most
recently with the introduction of the LCP, which is based
on the concept of an internal fixator with angular stable
screws locked within the plate [1,8,18,19].
Direct contact between the plate, the periosteum and
the ligaments should be avoided so that the soft tissue
layer and especially the periosteum, which is of major
importance for bone healing, is not compromised. This
concept has been applied in the TomoFix plate for the
medial open-wedge tibial valgisation osteotomy. The
excellent stability of the system allows early weightbearing without the use of bone grafts or bone substitutes. The shape of the plate is adapted to the corrected
medial cortex of the proximal tibia and allows subcutaneous, minimally invasive application and fixation,
without adjustment of the plate. The inclination of the
proximal screw holes leads to optimal positioning of the
screws parallel to the joint line. By means of special
spacer-bolts, the distance to the bone is kept greater than
2 mm during plate fixation, thus avoiding compression
of the medial collateral ligament and the pes anserinus
underneath the plate. The principle of the so called
combi hole, with the possibility of using conventional
screws in the same system, allows interfragmentary
compression of the lateral area of the osteotomy. The
presented surgical technique of open wedge osteotomy

Staubli et al.: TomoFix: a new LCP-concept


allows precise correction of alignment in all planes. The
V-shaped osteotomy has the advantage of additional
ventral bone contact and increases stability through the
tension band mechanism of the patellar tendon.
Indication
In this first series of cases, the indications for this procedure were deliberately very broad for the age of the
patients (nine patients over 65 years) and the extent of
the correction (up to 20 degrees).
Complications
All failures that led to re-operations such as revarisation, progression of osteoarthritis and delayed union
were seen in older patients, over the age of 64 years or
cigarette smokers. Two patients with progressive
osteoarthritis and the one patient with delayed healing
were treated with total knee arthroplasty. A total knee
replacement was recommended for the patient with
revarisation.
Revarisation
Correction losses after removal of the implant were
described only if the metal was removed less than six
months after the operation and in patients with insufficient correction (< 5 degrees femorotibial valgus). In one
case, with the implant in position, the screws migrated
through the proximal, cancellous-bone portion of the
tibial metaphysis, without visible radiological signs of
loosening. No implant failures occurred. From this
observation, it can be presumed that, especially in
elderly patients, the bone stock of the tibial metaphysis
may prove insufficient to maintain screw position, particularly if the mechanical axis is not corrected completely into the lateral compartment. On the basis of this
observation and dealing with the fact that bone density
increases exponentially close to the tibial plateau, we
inserted the proximal screws as close as possible to the
subchondral cortex of the tibial plateau. In addition, we
filled all four screw-holes in the proximal fragment to
improve the distribution of force.

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system was most stressed in the dorsal area of the
osteotomy, as the plate lies anteromedial and there is no
primary bone contact in the posterior aspect of the
osteotomy. This relative instability was shown by a frequently visible formation of callus at the posterior cortex. During the bone-healing phase, the tibial slope
showed no statistically significant change.
Delayed union
The single case that developed delayed union showed
an instability in the postoperative radiograph due to a
dehiscent fracture of the lateral cortex. The plate fixation was not performed correctly, because the fourth
locking-head screw was not placed in the proximal fragment, and the first screw distal to the osteotomy was not
fixed bicortically as recommended (Fig. 8). This led to
an insufficient stability which, through micro-motion in
the area of lateral osteotomy gap, led to delayed union.
To prevent pseudarthrosis, we started to pre-tension the
plate with a lag screw. This screw is placed after proximal fixation of the plate through the first sliding hole in
the plate, which results in primary contact and interfragmentary compression of the lateral cortex. Removing the previously inserted lag screw results in additional compression of the lateral osteotomy gap. By
inserting a bicortical, locked screw distal to the
osteotomy, the overall stability of the system allows
rapid bone healing.
According to the literature, exact adjustment of the
load-bearing axis is critical for a good long-term prognosis of a unicompartmental osteoarthritis with varus
alignment [12]. In the presented open-wedge osteotomy
technique, this can be achieved in all planes, including
rotation. In our series of cases, there is clear tendency to
undercorrect the deformity (mean femorotibial axis
after the operation: 8.2 degrees). This technical shortcoming in the surgical realisation of the preoperative

Loss of correction:
We observed a change in the tibial slope in the initial
phase, between the preoperative and postoperative values. During the operation, there was a tendency for the
slope to enlarge, as the strong mediodorsal ligaments
and the pes anserinus act against the opening of the
osteotomy. To prevent flexion malalignment, a soft-tissue release should be carried out, especially in the case
of contract medial capsule and ligaments. The tibial
slope was marked by a K-wire inserted subcutaneously
parallel to the direction of the joint surface. The fixation

Injury 2003, Vol. 34, Suppl. 2

Fig. 9: The osteotomy is held open with a bone spreader and


the TomoFix plate is inserted subcutaneous on the anteromedial aspect of the proximal tibia.

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plan can be overcome by fluoroscopic control of the leg
axis during surgery or by computer assisted surgery
[20].

Conclusions
The fixation system described here meets the stability
criteria that are necessary for an open-wedge correction
osteotomy on the tibia without interposition. Even in
cases with delayed healing no implant failure occurred.
Early functional postoperative rehabilitation is possible
and the preconditions for bone consolidation are fulfilled. Long-term follow-up examinations are necessary
to assess the quality of the newly formed bone, especially after removal of the implant. Premature removal
of the implant, i.e. before twelve months after the operation, can lead to secondary loss of correction, especially
in association with undercorrection.
The surgical technique needs careful attention otherwise failures, especially in respect of delayed healing,
may be encountered. Disorders of normal bone healing
and inadequate axial correction may also lead to treatment failures. Based on our experience, we do not recommend this surgical procedure for patients over the
age of 65 years or cigarette smokers.

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Correspondence address:
Carlo De Simoni
Klinik St. Anna, Luzern
E-mail: cc.desimoni@bluewin.ch