Clinical Biomechanics 108 (2023) 106056

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Clinical Biomechanics
journal homepage: www.elsevier.com/locate/clinbiomech

Development of a testing device for external wrist bridging dynamic

fixators used for distal radius fractures
Michael Stiehm a, *, 1, Ingmar Rinas b, 1, Levke Helfrich a, Heiner Martin a, Matthias Leuchter a,
Dagmar-C. Fischer c, Klaus-Peter Schmitz a, Thomas Mittlmeier b
a
Institute of ImplantTechnology and Biomaterials e.V., Rostock-Warnemünde, Germany
b
Department of Traumatology, Hand- and Reconstructive Surgery, Rostock University Medical Centre, Rostock, Germany
c
Department of Pediatrics, Rostock University Medical Centre, Rostock, Germany

A R T I C L E I N F O A B S T R A C T

Keywords: Background: Stabilization of extra-articular distal radius fractures by wrist joint bridging (WB) dynamic fixation
Wrist fracture allows for early motion of the wrist, but relies on exact positioning of the device. In fact, physiological movement
Dynamic fixation appeared to be compromised with even distinctly aberrant positioning of such device. To investigate this issue in
Biomechanics
more detail, we developed an in-vitro testing apparatus suitable for assessing the forces required for flexion and
Axis of rotation
extension of the wrist.
Methods: The experimental set-up enables the transmission of the translational movement of the traverse of a
universal testing machine into the main physiological movement (flexion and extension) of the wrist. An external
WB dynamic fixator was assembled to an artificial saw bone wrist model prior and after performing a wedge-
shaped osteotomy on the distal radius about 1.5 cm proximal to the joint line, i.e. generation of a fracture
model. The functionality of the fixator was evaluated under either condition and the effect of misalignment of the
external WB dynamic fixator was quantified by purposeful violation of the manufacture's instructions. Results
were statistically analyzed using the generalized linear mixed model.
Findings: Significantly higher loading was noted as the degree of misalignment increased. The normalized force
was significantly higher at a misalignment of 20◦ compared to 10◦ (10◦ : 4.13; 20◦ : 6.93, P < 0.001).
Interpretation: The proposed set-up turned out to allow highly reproducible and sensitive recording of the reaction
forces during flexion and extension of the wrist and thus is feasible for the evaluation and comparison of different
external WB devices.

1. Introduction 2022). To overcome such problems and/or to minimize the problems

related to the impaired abilities of the affected limb, the concept of an
Although distal intraarticular radius fractures are most frequently external wrist bridging (WB) dynamic fixator was introduced about 30
encountered in emergency departments, optimal treatment with respect years ago (Asche, 1995; Clyburn, 1987). In general, such a fixator con­
to the functional outcome is still a matter of discussion (Chen et al., sists of two rods with a hinge joint in between. The rods are mounted
2021; Guo et al., 2020). The widely used surgical approach, i.e. reduc­ proximal and distal to the wrist, i.e. within the radius and 2nd meta­
tion of the fractured bone (“open reduction”) and plate fixation comes carpal bone. To ensure flexion and extension of the wrist the center of
along with up to 27.9% of postoperative complications requiring addi­ rotation of the fixator has to be aligned with the center of rotation of the
tional surgery and/or an impairment of the functional outcome, espe­ wrist, i.e. the head of the capitate of the wrist (Neu et al., 2001; Youm
cially in intraarticular fractures (Arora et al., 2007; DeGeorge Jr. et al., et al., 1978). At first glance, this relies on the expertise of the surgeon
2020; Ma et al., 2016). Apart from temporary immobilization of the but inadvertent loosening of the mechanical coupling of the fixator rods
wrist secondary to the treatment of the fracture, restoring mobility might occur post-implantation during daily routines of the patient as
might require extensive physiotherapy afterwards (Pradhan et al., well.

* Corresponding author.
E-mail address: [email protected] (M. Stiehm).
1
Michael Stiehm and Ingmar Rinas are equally contributed to the study.

https://doi.org/10.1016/j.clinbiomech.2023.106056
Received 15 March 2023; Accepted 27 July 2023
Available online 28 July 2023
0268-0033/© 2023 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
M. Stiehm et al. Clinical Biomechanics 108 (2023) 106056

Fig. 1. Artificial wrist model consisting of an artificial forearm and hand (saw bone, SYNBONE AG, Switzerland) with attached external WB dynamic fixator (Galaxy
Wrist, Orthofix SRL, Italy). Radius and ulnar as well as the fingers of the artificial wrist model were cut and embedded in polymer resin (Demotec 20, Demotec Demel
e.K., Germany).

Our clinical experience indicates that even slight deviations from the required for physiological movement of the wrist, thus far and to the
desired position of the dynamic external fixation result in severely best of our knowledge these issues have not been investigated in detail.
reduced mobility of the wrist. Furthermore, any impairment of the In particular, such a test set up for the standardized ex-vivo biome­
mechanical integrity of the device might translate into a loss of fracture chanical testing should allow for guided physiological movement
reduction. (waving) of the hand and wrist in a reproducible manner allowing
While it appears reasonable, that both, the presence and the posi­ further to study systematically the influence of any fixator malalignment
tioning of an external wrist bridging device will modulate the force for the force coupling at the wrist joint. Here we report on the

Fig. 2. Universal testing machine (Mini Zwick Type 1120.25, BT1-FR2.5TN⋅D14, Zwick/Roell GmbH, Ulm, Germany) with mounted artificial wrist model and
attached external WB dynamic fixator (Galaxy Wrist, Orthofix SRL, Italy) in different phases of hand motion (extension (A), neutral position (B) and flexion (C)).

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M. Stiehm et al. Clinical Biomechanics 108 (2023) 106056

development and evaluation of such a test set-up and test procedure. artificial wrist models were measured prior and after mounting of the
WB external fixator. Furthermore, testing was conducted without and
2. Methods with a pre-defined deviation of the WB external fixator from the ideal
position. The violations of the manufacturer's instruction were used to
2.1. Wrist model and instrumentation with the external WB dynamic analyze the sensitivity of the wrist motion relative to the implantation
fixator aspects. Mounting of the device was according to the instructions of the
manufacturer, i.e. Schanz screws were placed in the distal radius and
For the experimental analysis the external WB dynamic fixator 2nd metacarpal bone of the intact artificial wrist model to enable sub­
(Galaxy Wrist, Orthofix SRL, Bussolengo, Italy) was utilized. This device sequent attachment and tightening of the clamps which in turn carry the
had been introduced into clinical use less than a decade ago (Aita et al., rods of the fixator (Fig. 2). Alignment of the center of rotation of the
2019). The fixator allows a guided movement of the wrist while limiting fixator with that of the wrist was achieved with the help of a Kirschner
the movement to one plane and allowing a controlled flexion and wire pointing to the head of the capitate (Neu et al., 2001). Subse­
extension within a range of motion (ROM) of ±40◦ . quently, the distal part of the fixator was locked and the proximal rod
The device consists of a joint module that ensures the mobility of the was correctly positioned in the medio-lateral and anterior-posterior
wrist, two 6.0 mm rods and a clamp on each rod to be fixed with two 4.0 plane before being locked as well. The device was considered to be
mm diameter shaft bone screws. The device was assembled onto an adequately positioned if manual flexion and extension (range of motion
artificial saw bone wrist model (right side, 448 mm of length, SYNBONE − 40◦ and + 40◦ , respectively) of the artificial wrist model reached
AG, Zizers, Switzerland; Order Number #9000). This model consists of minimum resistance. For each wrist model, 8 cycles of flexion and
generic but anatomically correctly shaped forearm and hand bones that extension were performed with continuous recording of the reaction
are connected by glue rubber to allow for flexion and extension of the forces. Subsequently, clamps of the WB external fixator were unlocked
hand similar to physiological movements of the wrist. and the center of rotation of the fixator was deviated by 10◦ and 20◦ in
For preparation of the experimental set-up the radius and ulnar of the palmar and dorsal direction, respectively. The reaction forces during
artificial wrist models were cut approx. 26 cm proximal to the styloid flexion and extension were recorded as before and were analyzed after
process of the distal radius and the artificial finger bones were cut at the normalization to the data obtained with the fixator correctly positioned.
metacarpal level. Both, the prepared forearm and the hand were This sequence of examinations was repeated i) after setting a wedge
embedded in polymer resin (Demotec 20, Demotec Demel e.K., Nid­ shaped osteotomy of the distal radius to model an extra-articular frac­
derau, Germany) to ensure a secure fit in the respective mount (Fig. 1). ture and ii) after additional stabilization of the fracture model by a
Kirschner wire inserted over the styloid process of radius. All procedures
2.2. Fracture model preparation were performed by the same orthopedic surgeon, who had appropriate
expertise of training.
In order to investigate the functionality of the fixator under condi­ Based on the hysteresis curve of the force-displacement diagram the
tions closely resembling reality, an oscillating saw (Makita DTM51, mechanical work was calculated and used as surrogate parameter to
Makita Werkzeug GmbH, Ratingen, Germany) was used to introduce a 5 quantify the load on the wrist. The mechanical work calculated for each
mm sized dorsal wedge-shaped osteotomy of the distal radius about 15 of eight cycles performed with the correctly mounted fixator was aver­
mm distal to the joint line. aged and subsequently used to normalize the mechanical work calcu­
lated for the wrist model with misaligned fixator.
2.3. Universal testing machine and the specific test set-up
2.5. Statistical analysis
The experimental set-up has to fulfill several requirements to allow
for a sound evaluation of external wrist bridging devices. Firstly, forces Statistical analysis was performed using R software (R Core Team,
required for flexion and extension of the wrist without and with the Auckland, New Zealand, version 4.2.1) and directed to evaluate i) the
implanted device have to be measured reproducibly. Secondly, the repeatibility of the measurements per artificial wrist model and condi­
sensitivity has to be sufficiently high to differentiate effects of a tion as well as ii) the sensitivity of the test set-up with respect to posi­
misalignment of 10◦ between the rotational axes of the wrist and the tioning of the fixator. Normal distribution of the data was investigated
implanted device. For mechanical testing a universal testing machine by means of the Shapiro-Wilk test and for multiple tests p-values were
(Mini Zwick Type 1120.25, BT1-FR2.5TN⋅D14, Zwick/Roell GmbH, adjusted according to Bonferroni. A Generalized Linear Mixed- (GLM)
Ulm, Germany) was used. The displacement of the upper jaw and the Model was applied to examine the interaction of the particular inde­
reaction force were simultaneously recorded during the test using a load pendent variables with the expected outcome, considering potential
cell (Zwick/Roell Xforce HP, nominal force 20 N) in combination with correlation within subjects due to the repeated measurements.
the testXpert III software (Version 1.2, Zwick/Roell GmbH, Ulm, Ger­ Deviation, direction and condition of assessment were considered as
many). The test set-up (Fig. 2) consisted of a base plate, which was fixed variables, whereas the subjects were considered as random
attached to the base plate of the testing machine. The forearm of the variables.
wrist model was mounted on the base plate by means of the polymeric
cast. In particular, the distance between the lower mount of the base 3. Results
plate and the arm holder could be adjusted to the length of the forearm
due to manual device assembly and bone preparation. The embedded A total of 11 wrist models were serially equipped with the same
metacarpal bones of the artificial wrist model were attached with the external WB dynamic fixator and each of these artificial wrist models
traverse of the testing machine by a rod with pivot joint. This pivot joint underwent the same sequence of examinations, i.e. measuring force
allowed the transmission of the translational movement of the testing during i) eight cycles of waving without fixator (baseline), ii) eight cy­
machine into the physiological movement (extension and flexion) of the cles of waving with correct alignment of both centers of rotation and iii)
wrist. To measure the misalignment of the fixator from the ideal position eight cycles each with 10◦ and 20◦ of palmar and dorsal misalignment,
a transparent goniometer was attached at the upper end of the fixator. respectively. This series of examinations was repeated after introduction
a wedge-shaped osteotomy prior to mounting the external WB dynamic
2.4. Study design fixator without and with additional placement of a Kirschner wire.
First of all, we realized that the absolute mechanical work required
The reaction forces generated due to flexion and extension of the for waving differs between the artificial wrist models even before

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eighth cycle indicated a high reproducibility of the test set-up (Table 1).
The consistent hysteresis of the second and the eighth cycle indicated a
reproducibility of the test set-up (mechanical workload: 48.6 Nmm ±
0.8 Nmm).
For the dorsally deviated fixator the area of the hysteresis was 17.8
times of the one recorded with the fixator mounted correctly. Under
such circumstances the needed mechanical load and therefore the en­
ergy loss could be attributed to a higher deformation of the wrist model
and friction of the joint module of the fixator. Furthermore, for the
dorsally deviated case the hysteresis of the eighth cycle was smaller
compared to the first cycle (822 Nmm vs. 870 Nmm).
The effects of either the degree of misalignment (10◦ vs. 20◦ ), the
direction of the deviation (palmar vs. dorsal) between the centers of
rotation of the fixator and the artificial wrist models as well as the
normalized forces obtained at different conditions (intact wrist model vs
fracture model vs. concomitant fixation of the fracture by means of
Kirschner wire) are summarized in Fig. 5.
According to the statistical analysis of the mechanical work the
following aspect could be detected. The level of misalignment had a
Fig. 3. The normalized mechanical work required for waving of the intact significant influence on the mechanical load and with increasing devi­
artificial wrist model after mounting of the external WB dynamic fixator ac­ ation of the axes the mechanical load increased (Fig. 5A). In addition,
cording to the instructions of the manufacturer. between palmar and dorsal misalignment a statistically significant dif­
ference of the mechanical work was noted (Fig. 5B). A wrist model with
mounting of the fixator. Thus, we decided to use this baseline data for a standardized fracture of the distal radius lead to significantly lower
subsequent normalization of the results and as an approach to eliminate mechanical work compared to an intact wrist model and a fixed wrist
the effects related to inherent features of the artificial wrist models. model with Kirschner wire (Fig. 5C). The lower mechanical work was
Secondly, we noted that the normalized mechanical work calculated for associated with a visible dislocation of the fractured wrist. The multi­
each of the wrist models after mounting the fixator according to the variate analysis confirmed the results of the univariate analysis.
instructions of the manufacturer was higher for the first three examined (Table 1). No significant interactions were found between the inde­
models (3.5 ± 0.4) than for the subsequent eight models (1.48 ± 0.34) pendent variables.
(Fig. 3). As this was considered to reflect the learning curve of the or­
thopedic surgeon, we excluded the data from these first three wrist
models.
Table 1
Fig. 4 depicts the normalized forces as a function of the angle of Estimated coefficient between the mechanical work and direction (palmar vs.
flexion and extension of the second and eighth cycle both with correct dorsal), condition of assessment (Reference: intact wrist model, fracture (con­
(A) and incorrect (B) mounting of the fixator. The second cycle was dition 2), stabilization with Kirschner wires (condition 3) and deviation from
chosen to account for the initial settling of the experimental setup. normal (10◦ vs 20◦ degree of misalignment); using the generalized linear mixed
Regardless of the positioning of the fixator, the measured and normal­ model (GLMM).
ized force describes a hysteresis. The area within the hysteresis loop Parameter Estimate SE Z-value P value
represented not only the mechanical work required for waving of the
(Intercept) 0.182 0.011 16.202 <0.001
hand, but also reflects the mechanical load on the wrist. The associated Direction − 0.019 0.007 − 2.706 0.007
energy loss can be attributed to the dissipation due to material internal Condition 2 (Ref.1.) 0.302 0.054 5.548 <0.001
friction of the rubber connectors of the wrist model. For each of the Condition 3 (Ref.1.) 0.093 0.039 2.407 0.01609
artificial models tested the hysteresis recorded from the second to the Deviation − 0.088 0.009 − 10.175 <0.001

Fig. 4. The force recorded during the 2nd (red) and 8th (blue) cycle of flexion (negative angle) and extension (positive angle) of the intact artificial wrist model with
precise alignment (A) and a 20◦ dorsal misalignment (B) between the center of rotation of the fixator and the artificial wrist joint. Mechanical load based on hysteresis
for both conditions were 49.2 Nmm vs. 46.8 Nmm (cycle 2 vs. cycle 8; condition A) and 890.0 Nmm vs. 822.4 Nmm (cycle 2 vs. cycle 8; condition B). (For
interpretation of the references to colour in this figure legend, the reader is referred to the web version of this article.)

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M. Stiehm et al. Clinical Biomechanics 108 (2023) 106056

Fig. 5. Comparison of the normalized work between different degrees of misalignment between the center of rotation of the fixator and the artificial wrist joint: (A)
for different directions of deviation from normal, (B) and for different conditions of testing the external WB dynamic fixator, (C) intact wrist model (condition 1) vs.
fracture (condition 2) vs. additional stabilization with Kirschner wires (condition 3) (p < 0.05 *, p < 0.01 **, p < 0.001 ***).

4. Discussion lower than in the intact artificial wrist model.

Different options for the surgical treatment of extra-articular distal

radius fractures ranging from Kirschner wires, plates, bridging and non- 4.1. Limitations
bridging external fixators up to intramedullary implants are available
(Aita et al., 2014; Costa et al., 2015; Gradl et al., 2014; Van Oijen et al., It has to be considered that the artificial arms are designed to illus­
2022). Although all of these techniques are able to stabilize an extra- trate anatomic details and/or to train surgical procedures and modes of
articular radius fracture and early mobilization of the patient, there is fixation rather than to assess biomechanical features, especially of the
still no consensus for ranking of these methods in terms of superiority joints. In fact, the joints in these wrist models are created by rubber glue
regarding the clinical and/or functional outcome (Aita et al., 2019; Egol and the elastic properties of this material are likely not only to differ
et al., 2008). However, because the wrist is required for almost all daily between the models but might change with extensive mechanic load.
activities, external dynamic wrist-bridging devices have been suggested Thus, to account for such inherent variability of the material properties
as a measure to reduce the burden of disabilities related to the even and to investigate the consequences of palmar and dorsal misalignment
transient immobilization of the wrist. with high reliability, we normalized all measurement to the findings at
In this study, we aimed to investigate the biomechanical behavior of baseline, i.e. forces recorded during the standardized motion of the non-
external wrist-bridging dynamic fixators using an artificial wrist model instrumented forearm.
and a specialized testing setup. Our results suggest that the anatomical
center of rotation of the wrist and the hinge joint of the external wrist 5. Conclusion
bridging dynamic fixator have to be aligned as precise as possible. Any
misalignment of the rotational axes is expected to interfere with the The proposed set-up turned out to allow highly reproducible and
flexion and extension of the wrist. sensitive recording of the reaction forces during flexion and extension of
In particular, the quality of implantation of dynamic fixators could the saw bone wrist model and thus is feasible for the evaluation of
be quantified by measuring hysteresis curves, which reflect the resis­ external dynamic WB devices. Apart from artificial wrist models the
tance against flexion and extension caused by misaligned centers of utilization of even cadaveric specimens can be considered for subse­
rotation. As anticipated, the resistance increased with the degree of quent investigations. Furthermore, it enables not only quantitative
deviation from the ideal position. Furthermore, palmar deviation training of surgeons but may help to bring the relevance of exact posi­
resulted in greater reaction force during flexion while dorsal deviation tioning of the external WB device to attention.
had greater impact on the extension. Although this was observed with
the intact artificial wrist model, it fits to our clinical experience, i.e. re-
adjusting an external WB device can improve an impaired and/or Funding
painful mobility of the wrist. It has to be noted that most studies focus on
the clinical outcome and not on mobilization during treatment (Cui This study received no external funding.
et al., 2012; Gu et al., 2016; Kulshrestha et al., 2011; Pennig, 1993).
Mounting the WB device to the injured artificial wrist model, i.e. Data
after osteotomy for modelling of an extra-articular distal radius fracture
revealed that any deviation from the correct positioning of the device Data and code will be available from the corresponding author upon
reduced the mechanical load for flexion and extension, as well. This is reasonable request.
most probably due to an evasive movement of the radius especially at
the site of the fracture. However, in a clinical setting it is the main goal
to fix the fragments according to their anatomical position during Declaration of Competing Interest
healing as any displacement bears the risk of incomplete healing and
subsequent adverse sequelae (Gradl et al., 2013; Liu and Bai, 2020). In None.
such a situation, the additional application of Kirschner wires represents
an established tool for fixation of the fracture and this holds true even for Acknowledgement
our test set-up. Indeed, after stabilization of the fracture the normalized
force required for flexion and extension rose significantly, but was still Not applicable.

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