Clinical Device-Related Article Osteotomy of Distal Radius Fracture

Clinical Device-Related Article
Osteotomy of Distal Radius Fracture Malunion Using a Fast
Remodeling Bone Substitute Consisting of Calcium Sulphate
and Calcium Phosphate
Antonio Abramo,1 Mats Geijer,2 Philippe Kopylov,1 Magnus Tägil1
1
Department of Orthopaedics, Hand Unit, Clinical Sciences, Lund University, Lund S-221 85, Sweden
2
Department of Radiology, Lund University Hospital, Lund S-221 85, Sweden
Received 2 May 2008; revised 29 May 2009; accepted 16 June 2009
Published online 10 November 2009 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/jbm.b.31524
Abstract: Malunion after a distal radius fracture can be treated with an osteotomy of the
distal radius. Autologous iliac crest bone graft is often used to fill the gap, but the procedure is
associated with donor site morbidity. In this study a novel fast resorbing biphasic bone
substitute consisting of a mixture of calcium sulphate and calcium phosphate is used
(CeramentTM BoneSupport AB, Sweden). Fifteen consecutive patients, with a mean age of 52
(27–71) years were included. All had a malunion after a distal radius fracture and underwent
an osteotomy. A fragment specific fixation system, TriMed1 (TriMed, Valencia, CA),
consisting of a Buttress Pin1 and a Radial Pin Plate1 were used for fixation and a calcium
sulphate and calcium phosphate mixture as bone substitute. The patients were followed for 1
year. Grip strength increased from 61 (28–93)% of the contralateral hand to 85 (58–109)%, p
< 0.001. DASH scores decreased from 37 (22–61) to 24 (2–49) p 5 0.003. Radiographically all
osteotomies healed. An increase of ulnar variance was noted during healing from 1.8 mm
immediately postoperatively to 2.6 mm at final follow up. Osteotomy can increase grip
strength and decease disability after a malunited fracture. In the present series the bone
substitute was replaced by bone, but a minor loss of the achieved radiographic correction was
noted in some patients during osteotomy healing. A more rigid fixation may improve the
radiographic outcome with this kind of bone substitute. ' 2009 Wiley Periodicals, Inc. J Biomed
Mater Res Part B: Appl Biomater 92B: 281–286, 2010
Keywords:
calcium sulphate; calcium phosphate; osteotomy; distal radius; bone substitute
INTRODUCTION
Malunion after a distal radius fracture is a major cause for
residual symptoms. It appears in about 5% of the fractures1
and the patients may suffer from decreased grip strength,
poor hand and arm function and poor cosmetic appearance.
To correct the deformity and relieve the symptoms, an osteotomy can be performed.2–4 The malunited fracture is cut
at the fracture site and the length and/or angle is corrected
using an opening wedge technique. An iliac crest bone graft
is most often used to fill the gap, either as a structural single
block of cortico-cancellous bone or as a nonstructural cancellous graft.5 A high incidence of donor site morbidity has been
Correspondence to: A. Abramo (e-mail: [email protected])
Contract grant sponsor: Region Skåne, Lund University Hospital
Contract grant sponsor: Swedish Research Council-Medicine; contract grant
number: 090509
Contract grant sponsors: Stiftelsen för bistånd åt rörelsehindrade i Skåne, Alfred
Österlund, Greta and Johan Kock, Crafoord and Maggie Stephens foundations, Faculty of Medicine Lund University
' 2009 Wiley Periodicals, Inc.
reported,6 most commonly in the form of pain but also as
wound infection or even fracture of the iliac crest.
To avoid donor site morbidity, a bone substitute can be
used instead of bone graft. Fast resorbing calcium sulphate
has been used, and although being highly biocompatible,7
the resorption rate has been too rapid to be used in fracture
treatment. Without rigid fixation, the risk of mechanical
failure during the remodeling is obvious but at the same
time a rigid fixation decreases the bone formation stimulus.8 Instead a nonresorbable bone substitute, such as calcium phosphate paste can be used. The injectable bone
substitute is deposited into the fracture or osteotomy and
sets in situ to carbonated hydroxyapatite (HA), which
retains its mechanical properties during healing. HA has
been used both in surgery of distal radial fractures9 and in
osteotomies of malunited distal radial fractures.10–12 However, it takes years,13 if ever, to resorb and ideally a bone
substitute should be resorbed within reasonable time but
still maintain the strength until bone has formed. In the
present study a novel injectable bone mixture containing
281
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ABRAMO ET AL.
both a calcium sulphate, resorbing during 6–12 weeks and
a nonresorbing HA will combine the two resorption
extremes with the hypothesis that the HA will provide
structural support during the remodeling and the calcium
sulphate will be remodeled swiftly into bone. The aim of
this study was to evaluate the feasibility of using the calcium sulphate/calcium phosphate substitute as gap filler in
distal radius osteotomies in combination with the fragment
specific fixation technique, which has previously been used
as fixation in combination with a nonresorbing HA.11
MATERIALS AND METHODS
Fifteen patients were included prospectively as a feasibility
study of a biphasic bone substitute. The study was
approved by the regional research ethics committee and the
Swedish Medical Products Agency.
Patient Selection
Inclusion criterias for this study were a malunited distal radius fracture, healed with a dorsal or volar angulation and/
or shortening and with a clinically manifesting symptom
such as pain at rest, pain at activity or decreased range of
motion. Patients were enrolled from two hospitals in the
southern region of Sweden. Between October 2005 and November 2006, 15 consecutive patients with a malunion after
a distal radial fracture underwent an osteotomy using the
fragment specific system for fixation and the biphasic bone
substitute as gap filler. The mean age in the study group
was 52 (27–71) years; four patients were men and 11
women. Eight patients were operated on their left wrist and
seven on their right. Eight were operated on their dominant
wrist.
The mean ulnar variance was plus 2.4 mm (0–9.2), the
mean dorsal angulation was 17.98 (29.4 to 38.2) and
the mean radial inclination was 19.28 (8.8–30.2). All the
patients had had their fractures treated by closed reduction
and fixation in a below elbow cast as primary fracture
treatment.
Presurgical Preparation
Blood samples were collected preoperatively and at each
follow up, analyzing the platelet count, thyroid hormone,
thyroid stimulating hormone, calcium and CRP to monitor
any potential side effect of the dissolving bone substitute.
Preoperative radiographs including a lateral and an anterior–posterior view were taken A clinical examination was
performed with measuring of the grip strength and preoperative pain level and patients filled out a preoperative
DASH-from.
Surgical Protocol
All operations were performed by two surgeons (A.A. and
P.K.). The technique has been described previously but
Figure 1. AP and lateral radiographs of a patient operated with a
distal radius osteotomy using Radial Pin Plate1, Pins, Buttress Pin1
and screws. The bone substitute is used to fill the gap.
with the use of Norian SRS1, a single phase substitute
consisting of a HA (dahlite), as a bone substitute instead of
this novel biphasic CS/HA material.11 In all osteotomies
the fragment specific fixation system was used for fixation
and the the biphasic bone substitute as gap filler. The fixation system is a fragment specific fixation device for distal
radial fractures consisting of plates and pins. In the osteotomy technique in the present study a Radial Pin Plate1
and a dorsal Buttress Pin1 were inserted using two separate incisions. A dorsal incision was made through the
fourth compartment to perform the osteotomy and to introduce the Buttress Pin1 and the bone substitute (Figure 1).
A second radio-volar incision was centered over the styloid
and the first extensor tendon compartment to allow for
placement of the radial pins and the Radial Pin Plate1.
Once a correct level for the osteotomy was established, the
radius was cut with an oscillating saw, leaving the periosteum intact at the volar side. The dorsal and radial malalignment were corrected. The osteotomy was temporarily
secured by the Buttress Pin1, which could be slid to correct the axial deformity. The Buttress Pin1 screw was
tightened, the radial pins inserted and the correction controlled in the fluoroscope. Before injecting the bone substitute, the Radial Pin Plate1 was applied to secure full
stability. Postoperatively the wrist was immobilized in a
plaster cast for 2 weeks and thereafter active mobilization
was encouraged in a removable soft splint.
Bone Substitute
A novel bone substitute has been developed allowing new
bone tissue to grow into the bone defect made possible by
certain porosity.14 It is an injectable bone substitute and
consists of 60% calcium sulphate (CS) and 40% HA.15
Journal of Biomedical Materials Research Part B: Applied Biomaterials
OSTEOTOMY WITH A CALCIUM SULPHATE/CALCIUM PHOSPHATE BONE SUBSTITUTE
This ratio gives the mixture a compressive strength of 35–
50 MPa comparable to trabecular bone and a better strength
than with a 50/50 ratio of CS and HA.16 Both the CS and
the HA are synthetically made to control quality and purity
of the mineral phases. The HA is of medical grade and
tested according to American standard, ASTM F1185. The
HA particles are small (\100 lm) and high temperature
sintered to give a round shape and smooth surface for optimal handling characteristics.
The bone substitute powder is mixed with OmnipaqueTM
(GE HealthCare) a low osmolar, nonionic, iodinated contrast agent (iohexol), to form an injectable paste. The working time and injectability of the substance is 7 minutes
using a 16G cannula and the final setting time is
25 minutes. The setting temperature is 39 centigrade.
Follow-up
Clinical follow ups were performed at 2 weeks, 7 weeks,
3 months and at 1 year. These follow ups include clinical
examination, blood samples, radiographic examination and
the DASH form.
The subjective and objective outcomes were followed
prospectively to monitor the clinical improvement by the
operation per se.
Radiographs
Radiographs were obtained preoperatively, postoperatively
and at every follow-up to monitor the mechanical integrity
of the bone substitute during remodeling. A radiologist
(M.G.) measured all radiographs. Radial shortening was
measured as ulnar variance from the distal radial surface to
the distal ulnar surface according to the method of perpendiculars on AP radiographs of the wrist obtained in the
neutral position. The radial inclination angle was measured
on the AP radiographs and the dorsal angulation on the lateral view, expressed as the angle of joint surface relative to
the radial length axis.17 The resorption of bone substitute
was evaluated in the radiographs, by estimating the amount
of remaining radio-opaque material in the gap. The degree
of radiographic healing of the osteotomy was also appreciated in no healing, partial healing and definite healing.
283
general use in upper extremity disorders but not specifically
for distal radius fractures.19 The questionnaire consists of
30 questions evaluating physical activities, symptom severity and the effect of the injury on social activities. A score
is calculated and the disability of the patient is estimated
on a scale from 0 to 100, with 100 being the worst result
that is reflecting the highest degree of disability. At study
entry, the mean pain as measured on a visual analogue
scale (0–10 cm) was 5.5 (3–10) and the mean DASH score
was 37 (22–61).
Statistics
Student’s paired t-test was used to compare pre- and postoperative data as well as to evaluate radiographic changes
within the first year. Repeated measures ANOVA was used
for repeated measures within the group and Wilcoxon’s
rank sum test to compare pre- and postoperative DASH
and pain scores. The SPSS program (SPSS, Chicago, IL)
version 14.0 was used for the statistical analyses.
RESULTS
All patients were admitted as outpatients. Eleven of the 15
patients could return home the same day and the others the
morning after. One patient had the pins and plate removed
at 8 months postoperatively due to pain from the Radial
Pin Plate1. The osteotomy was healed at that time. There
were no adverse events correlated to the bone substitute at
follow up, neither by clinical examination nor in the blood
samples. There were seven adverse events correlated to the
surgery or to the fixation device. One patient had a rupture
of the extensor pollicis longus tendon (EPL) treated by an
extensor indices proprius tendon (EIP) transfer. One patient
had a carpal tunnel syndrome treated by carpal tunnel
release. One patient had a postoperative wound infection
which was treated successfully with antibiotics and healed
uneventfully. Three patients had local pain and tenderness
due to the Radial Pin Plate1, in one patient due to a pin
which had to be removed and in two patients due to a transient irritation of the tendons in the first dorsal compartment and the radial nerve branches.
Objective
Tests
Grip strength was measured using a dynamometer (Jamar;
Preston Corp, Jackson, MI). The mean preoperative grip
strength was 61% (28–93%) of the contralateral, uninjured
side.
The patients rated their pain at activity and at rest on a
10 cm visual analog scale (VAS) and the functional outcome was evaluated using the Swedish version of the validated outcome score disability of the arm, shoulder and
hand (DASH). DASH is a self-administered questionnaire
developed by the AAOS and the Institute for Work and
Health in Canada.18 The Swedish version was validated for
Journal of Biomedical Materials Research Part B: Applied Biomaterials
The mean operation time was 75 (58–91) minutes. Grip
strength increased from 61% (28–93%) of the uninjured
side preoperatively to 85% (58–109%, p \ 0.001) at 1 year
(Figure 2).
Subjective
The preoperative pain at rest as measured on a visual analogue scale (0–10 cm) vas 5.5 (3–10) and decreased to 2.4
(1–6) at 1 year (p \ 0.001). The mean DASH score was
37 (22–61) preoperatively and improved to 24 (2–53) already at 3 months postoperatively (p 5 0.011). The score
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ABRAMO ET AL.
operatively and 22.28 (219.3 to 17, p 5 0.001) at the final
follow up (Figure 4, Table I). In three patients, there was a
more than 1 mm loss of ulnar variance correction from
immediately postoperatively (mean 4.6 mm, range 2.8 to
7.8 mm) to the 1 year follow-up (mean 6.4 mm, range 4.6–
9.4 mm). One additional patient who had one of the radial
Figure 2. Mean grip strength expressed as a percentage of the
contralateral wrist; preoperatively and at follow up. Error bars represent 95% confidence interval.
improved further and was 20 (2–49) at 1 year (p 5 0.003)
(Figure 3).
Radiology
Radiographically, all the osteotomies healed. One patient
fell due to a minor cerebral infarction, traumatized her
wrist and the pins broke with a loss of correction. As
expected a high rate of early decrease in radiolucent material in the gap was noted. The mean ulnar variance for the
whole group was 12.4 mm (0–9.2) preoperatively, 11.9
mm (21.0 to 7.8 mm) immediately postoperatively and
12.6 mm (20.6 to 9.4 mm) at the final follow up. These
changes were statistically not significant. The mean radial
inclination was 19.38 (8.8–30.2) preoperatively, 22.98
(14.9–30.8) postoperatively and 24.38 (18.0–32.6 p 5
0.002) at 1 year. The mean dorsal angulation was 17.9
(29.4 to 38.2) preoperatively, 21.18 (215.0 to 12.2) post-
Figure 3. DASH score and VAS pain (cm) at rest, preoperatively
and at follow up. Error bars represent the 95% confidence interval.
Figure 4. Radiographic appearance at follow up. An improvement
is seen in dorsal angulation and radial inclination but there is no significant change in ulnar variance. Error bars represent 95% confidence interval.
Journal of Biomedical Materials Research Part B: Applied Biomaterials
OSTEOTOMY WITH A CALCIUM SULPHATE/CALCIUM PHOSPHATE BONE SUBSTITUTE
TABLE I. Radiographic Results
Mean (range)
Ulnar variance
Preop
Postop
2 week
7 week
3 month
1 year
Radial inclination Preop
Postop
2 week
7 week
3 month
1 year
Dorsal angulation Preop
Postop
2 week
7 week
3 month
1 year
2.4
1.9
2
2.4
2.8
2.6
19.3
22.9
23.8
24.4
24
24.3
17.9
21.1
23
23
23.9
22.2
(0–9.2)
(21 to 7.8)
(21.6 to 8.6)
(21.2 to 9.2)
(21.4 to 10)
(20.6 to 9.4)
(8.8–30.2)
(14.9–30.8)
(19.4–35)
(16.9–32.5)
(18.9–32.6)
(18–32.6)
(29.4 to 38.2)
(215 to 12.2)
(217.8 to 13.7)
(219.9 to 19.7)
(219.7 to 19.3)
(219.3 to 18.2)
a
SD p-Value
2.4
2.3
2.5
2.7
2.8
2.4
5.1
4.5
5.1
4.6
4.0
4.4
12.9
8.7
9.0
11.7
13.0
9.9
1
0.9
1
1
1
0.2
0.001
\0.001
0.004
0.002
0.001
\0.001
\0.001
\0.001
0.001
a
p-value compared to preoperative values. Repeated measures ANOVA with
Bonferroni correction.
pins removed due to spontaneous retraction underwent an
ulnar shortening osteotomy at 8 months after the osteotomy
because of persisting pain and poor range of motion and a
radiographic shortening of the radius.
DISCUSSION
Bone substitutes are used to avoid donor site problems
associated with the harvest of iliac crest bone graft. The efficacy of both the operation per se and the use of bone substitute have been shown in previous studies. Most often an
unresorbable HA is used in combination with K-wires in a
closed fashion,10 in combination with an open but minimal
invasive fixation technique as described in the present
study,11 or as a full open technique using a volar fixed
angle plate.12 Using bone substitute, osteotomy of the distal
radius can be performed as an outpatient procedure.
The choice of which bone substitute to use is of importance in relation to the choice of fixation method. A pure
hydroxyl apatite bone substitute takes a long time to resorb,
if ever, and the surrounding healing bone at best incorporates and bridges the void filler. Ideally, a faster resorbing
gap filler would allow for quick remodeling of the bone
substitute into bone to normalize mechanical integrity. In
this study we combined the slow-resorbing calcium-phosphate (HA) providing structure during remodeling with a
faster resorbing, or dissolving, calcium sulphate which can
be replaced by bone. Previous reports on composite graft
of this kind consisting of 40% CS and 60% HA have
shown promising results especially when combined with
osteoinductive factors. 20
The mixture of a solid and a soluble phase of the bone
substitute allow manipulation of the bone healing and
Journal of Biomedical Materials Research Part B: Applied Biomaterials
285
remodeling. Drugs can be added to the soluble phase to be
released during the four first weeks. Besides antibiotics,
theoretically a bone morphogenic protein (BMP) or another
osteoinductive peptide can be added to increase bone formation. A further advantage might be that the elasticity
modulus of the biphasic bone substitute (0.3–0.4 GPa) is
equivalent to cancellous bone and will decrease the shear
forces at the bone substitute to bone interface. HA has a
higher modulus and with a stiffer material, stress shielding
of the bone surrounding the bone substitute might lead to
resorption.
As Demonstrated in this Study, the Reduction can be
Lost in Some Patients During the Remodeling
With a fast resorption of the bone substitute, such as with
the present bone void filler, the fixation becomes more important and more rigid solutions are necessary. Without
being bulky, the Fragment specific fixation system is more
rigid than pins alone and the same fixation strength is
reached as with a volar angle stable plate, at least in
cadaver studies.21 In vivo, when diverging muscle forces
are added as in the present study, the fixation in some cases
does not seem to be rigid enough. Although the dorsal
angulation was unaffected, axial compression occurred during the remodeling in four patients. A delicate balance thus
exists between on one hand the wish to speed up the
remodeling, but at the same time without losing the mechanical integrity during the remodeling.
The objective results in the present study regarding
increased grip strength and pain relief are good and equivalent to previous studies in osteotomies of the distal radius
using bone grafts.2,22,23 In the present series grip strength
increased to 85% of the uninjured side which is better or
comparable to other studies with plating and a conventional
bone graft5,22 or a bone substitute.10–12 Also subjectively, a
substantial improvement was recorded using the DASH
outcome score. DASH decreased from 37 preoperatively to
20 at the final follow up. The results all implicate that the
operation offers a substantial improvement of the symptoms but no normalization. A faster resorbing bone substitute like this biphasic CS/HA substitute can be used as a
safe alternative to bone graft. Still 4 of 15 patients lost
some radial length during the remodeling period and
although no correlation was found between radiographical
and subjective outcome in the present study, it has previously been shown to influence the outcome.24 In the
authors’ opinion a careful choice of fixation is recommended with the relatively fast resorption of the calcium
sulphate component of the biphasic bone substitute and
more rigid fixation may be necessary. This might be
obtained by adding an Ulnar Pin Plate or by a complete
change of fixation device to a volar fixed angle plate to
prevent the loss of reduction.
The authors thank research nurse Marlene Andersson for excellent assistance and PhD Malin Nilsson for valuable advice. The
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ABRAMO ET AL.
project was monitored by BoneSupport AB, Lund, Sweden who
supplied the Cerament.
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Journal of Biomedical Materials Research Part B: Applied Biomaterials