Injury 53 (2022) 1283–1288

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Injury
journal homepage: www.elsevier.com/locate/injury

Original article

Can Hardware Removal be Avoided Using Bioresorbable Mg-Zn-Ca

Screws After Medial Malleolar Fracture Fixation? Mid-Term Results of
a First-In-Human Study
Valentin Herber a,b,∗, Viktor Labmayr a, Nicole G. Sommer a, Romy Marek a, Ulrike Wittig a,
Andreas Leithner a, Franz Seibert a, Patrick Holweg a
a
Department of Orthopaedics and Traumatology, Medical University of Graz, Auenbruggerplatz 5/6 8036 Graz, Austria
b
Department of Dentistry and Oral Health, Division of Oral Surgery and Orthodontics, Medical University of Graz, Billrothgasse 4, 8010 Graz, Austria.

a r t i c l e i n f o a b s t r a c t

Article history: Ankle is the most common site of hardware removal, mainly performed within 12 months of the primary
Accepted 27 October 2021 surgery. The prominence of the metallic hardware is a frequent cause of pain after fracture fixation. Over
the last decade, the development of bioresorbable materials based on magnesium (Mg) has increased.
Keywords: Bioresorbable metals aim to avoid a second surgery for hardware removal.
Bioresorbable Material Methods: Twenty patients with isolated, bimalleolar, or trimalleolar ankle fractures were treated with
Magnesium-Based Implant bioresorbable screws made of Mg, 0.45wt% calcium (Ca) and 0.45wt% zinc (Zn) (ZX00). Patient-reported
Alloy outcome measures (PROMs) including visual analogue scale (VAS) for pain, the presence of complications
Medial Malleolar 6 and 12 months after surgery and the AOFAS scale after 12 months were reported. The functional out-
Fracture
comes were analysed through the range of motion (ROM) of the ankle joint with a standard goniometer.
Degradation products and the bioresorbability of the screws were evaluated using plane radiographs.
Results: One patient was lost to follow-up. All patients were free of pain, no complications, shoe conflict
or misalignement were reported after 12 months of follow-up. No Mg screws were surgically removed.
An additional fixation of the distal fibula or the dorsal tibial fragment with conventional titanium im-
plants (Ti) was performed in 17 patients. Within 12 months after primary refixation, 12 of these patients
(71%) underwent a second surgery for Ti hardware removal. The mean AOFAS score was 89.8±7.1 and the
difference between the treated and the non-treated site in the ROM of the talocrural joint was 2°±11°
after 12 months. Radiolucent areas around the screws were attributed to degradation and did not af-
fect clinical or functional outcomes. After one year, the Mg screw heads could not be detected in the
plane radiographs of 17 patients which suggests that the majority of the screw head is degraded without
introducing adverse reactions.
Conclusions: At 6 and 12 months, the bioresorbable Mg screws show excellent PROMs without compli-
cations or need for screw removal. The resorbability of the screw heads in most of the patients after
one year could also provide an advantage over conventional bio-inert implants by avoiding related skin
irritation due for instance to shoe conflict.
© 2021 The Author(s). Published by Elsevier Ltd.
This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)

Introduction either isolated or associated with lateral or posterior malleolar

Ankle fractures are the second most common fracture requiring
hospitalization while the incidence from different clinical trial
varies from 71 to 187 per 10 0,0 0 0 person-years (1:800) [1–3].
Medial malleolar (MM) fractures are frequently found and can be
∗
Corresponding author. Dr. Valentin Herber, Department of Orthopaedic Surgery
and Traumatology, Department of Dentistry and Oral Health, Billrothgasse 4, 8010
Graz, Austria
E-mail address: valentin.herber@medunigraz.at (V. Herber).
fracture [4]. The treatment of MM fractures depends on the frac-
ture type and stability of the fracture. Current treatment concepts
recommend open reduction and internal fixation (ORIF) of unsta-
ble medial malleolar fractures [2,5]. Different surgical approaches
including fixation with screws only or in combination with plates
can be used [6], but the most commonly employed and accepted
clinical technique is the open reduction of medial malleolar frac-
tures and fixation with cancellous screws [7]. Closed reduction and
percutaneous fixation for MM fractures have been described, but is
not generally recommended due to the lack of direct visualization

https://doi.org/10.1016/j.injury.2021.10.025
0020-1383/© 2021 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)
V. Herber, V. Labmayr, N.G. Sommer et al.
and access to the fracture site for debridement [8]. Conventional,
bio-inert metallic implants (such as steel or titanium (Ti) alloys)
are considered the gold standard in surgical fracture fixation.
Recent clinical trials demonstrated that the MM fractures can be
sucessfully stabilized with a single Ti screw [9–11]. Due to the
persistence of the material in the operating site, complications
such as pain, soft tissue irritation due to hardware prominence,
deep late infection, metal allergy or toxicity, hardware migration
and metal failure were reported post-operatively [11–13]. Assess-
ing patient’s discomfort, it is sometimes difficult to determine,
whether the pain or discomfort is due to the implant left in situ
or patient’s subjectivity. In many cases, metalwork is removed in
both symptomatic but also asymptomatic patients for a variety
of reasons, differing between surgeons and even countries and
was recently estimated between 13% and 27% [14,15]. In Germany,
in about 80% of treated fractures, hardware was removed, which
represents 176,257 surgeries in 2018 [16]. Similar numbers were
also found in the USA [17]. These operations are associated with
possible complications, such as intraoperative breakage of hard-
ware, post-operative infection, compromised wound healing, and
significant iatrogenic injuries [12,17]. Metalwork removal from the
ankle is inextricably associated with significant health care costs,
estimated for instance as a minimum of 1113 Euros per surgery
in Europe for the removal of hardware under general anaesthetic
as a day case procedure [14]. Due to (i) the current increase of
patients over the age of 65, which are expected to triple by 2030
[18], and the correlated increase of potential related fractures,
(ii) the thinner and vulnerable tissues in elderly patients, (iii)
the patient comfort and (iv) the associated costs, bioresorbable
Mg-based materials which do not require a second stage surgery
for hardware removal appear to be an urgent clinical need.
Since some decades, new alternative and innovative material
options for ankle fracture fixation, such as bioresorbable magne-
sium (Mg)-based alloys were developed. With an elastic modu-
lus similar to that of cortical bone, these alloys minimize the
stress shielding effect characterized by the resorption of surround-
ing bone tissue according to Wolff’s laws [19]. Additionally, bio-
compatibility as well as antimicrobial and osteoconductive proper-
ties of Mg-based alloys have been exhibited [20]. Many biomedi-
cal Mg-alloy systems have been investigated, mainly focusing cal-
cium (Ca), zinc (Zn), zirconium, strontium and/or rare earth ele-
ments (REE), such as lanthanum, yttrium, neodymium and gadolin-
ium [21–23]. REE are used in Mg-based alloys to improve the cor-
rosion resistance, hence reducing the degradation rate [24]. How-
ever, some REE like yttrium previously showed cytotoxic effects on
murine fibroblasts and osteoblasts [25] as well as a concentration-
dependent cell apoptosis in vitro [21,26]. Only few studies focused
on related biological effects of REE and there is a lack of high-
quality research in the literature.
Mg-based alloys composed of nutrient elements, such as the
proposed Mg-alloy (Mg 0.45wt% Ca and 0.45wt% Zn; denoted as
ZX00) exhibited suitable biomechanical properties, biocompatibil-
ity, bioresorbability and osteoconductivity in a large animal model
[27]. According to a “bench-to-bedside” approach, a pilot study in-
vestigating the use of ZX00 screws in medial malleolar fractures
was designed. The 12 week results of the clinical trial have already
been published [28]. Fracture union was successfully achieved
without adverse events in all 20 patients [28]. As late patient’s
discomfort or complications after fracture healing occur generally
within 12 months after primary surgery, mid-term clinical, patient
reported outcomes measures and functional outcomes are essential
in order to evaluate fractures treated with Mg-based implants [14].
Therefore, the aim of this study was to evaluate the clinical, func-
tional and radiographical outcomes of medial malleolus fractures
treated with lean ZX00 compression screws after 6 and 12 months
of follow-up.
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Injury 53 (2022) 1283–1288
Materials and methods
The study design was a prospective, non-randomized cohort
study for the treatment of displaced fractures of the medial malle-
olus with ZX00 as a pilot first-in-human study [28].
As previously described, this trial included 20 patients (11
males and 9 females with a mean age of 40.1 years (SD 14.5)) who
were recruited between July 2018 and October 2019. The study
was approved by the local Ethics Committee (28-071 ex 15/16) and
was conducted according to the Good Clinical Practice standards
and the Declaration of Helsinki. Inclusion criteria were subjects be-
tween 18 and 65 years old presenting with a displaced isolated
medial malleolus fracture, a bimalleolar ankle fracture or a tri-
malleolar ankle fracture. Fracture displacement was defined as di-
astasis of the fracture in any direction of 2 mm or more. Exclusion
criteria were pathological fractures, underlying diseases (in par-
ticularly bone diseases, kidney diseases, diabetes mellitus), poly-
traumatized patients and pregnant or breastfeeding women. Frac-
tures were classified using the Hersovici classification.
Written informed consent was obtained from each patient be-
fore surgery. Bioresorbable, partially threaded, non-cannulated cor-
tical screws with a diameter of 3.5 mm and a length of 40 mm
were used as compression screws. The screws were made from
ZX00 rods, consisting of 99.1 wt% Mg, 0.45 wt% Zn and 0.45 wt% Ca
without any surface treatment. The screws were manufactured by
computer numerical control machining from extruded rods (Fig. 1).
Packaging and sterilization by gamma irradiation was performed
after a cleaning process including immersion in an ultrasound bath
of acetone. Under general anesthesia and after reduction of the
fracture, two bioresorbable Mg screws were inserted to fix the frac-
ture of the medial malleolus. In cases of combined fractures (bi-
malleolar and trimalleolar fracture) the other fragments were re-
fixed with conventional Ti implants.
PROMs including pain, assessed by a visual analog score (VAS)
and the report of adverse events such as anormal vital signs,
erythema, swelling, secretions, wound healing disorders, wound
infections, implant infections, skin irritation, discomfort related to
prominent screws, allergic reaction or screw failure were investi-
gated after 6 and 12 months. The American Orthopedic Foot and
Ankle Society (AOFAS) score was performed after 12 months. Blood
analysis regarding Ca, Mg and renal function were recorded 6 and
12 months after the surgery. Functional outcomes were evaluated
through range of motion (ROM) in dorsal and plantar flexion
with a standard goniometer. Additionally, anterior–posterior and
lateral ankle radiographs performed after 6 and 12 months were
evaluated in regard to screw breakage, loosening, degradation, or
any bony disorder including non union, delayed union, bone loss,
or infection during the degradation of the screws. Degradation
Fig. 1. Partially threaded, non-canulated compression screw used in the prospective
trial. Implants had a diameter of 3,5 mm, a length of 40 mm and were threaded at
the distal part for use as traction screws.
V. Herber, V. Labmayr, N.G. Sommer et al.
Fig. 2. Anteroposterior and lateral ankle radiographs of a 29-year-old male patient with a medial malleolar fracture (A) stabilized with two Mg-based screws after open
anatomical reduction. After 6 months (B), a complete fracture consolidation is observed, with radiolucent zones within the bone surrounding the screws (white arrows).
These radiolucent zones resulting from the degradation of the screws decreased slightly between 6 (B) and 12 months (C). The blue arrows show the screw heads 6 months
after surgery (B). At the last follow-up time point, the heads of the screws are almost completely resorbed (blue arrows). (For interpretation of the references to colour in
this figure legend, the reader is referred to the web version of this article.)
product building and screw integrity were assessed using postop-
erative X-ray after 24 and 52 weeks as a longitudinal investigation.
A descriptive analysis of the data was performed using propor-
tions, frequency and distributions and are given as mean ± and
standard deviation (SD).
Results
One patient was lost to follow-up after 12 weeks. Concerning
PROMs, all remaining 19 patients were free of pain 24 and 52
weeks after surgery. At clinical examination, all patients showed
a regular postoperative scar at the 1-year follow-up. No ad-
verse events or screw related complications including erythema,
swelling, secretions, wound healing disorders, wound infections,
soft tissue irritation or allergies were reported. At the final follow-
up examination the mean AOFAS score was 89.8±7.1 points. No pa-
tient needed a second operation for Mg screws removal. In com-
parison, an additional fixation of the distal fibula or the dorsal tib-
ial fragment with conventional Ti implants was performed in 17
patients (90%). Within 12 months after primary refixation, 12 of
these patients (71%) underwent a second surgery for the removal
of the additional Ti implants. The most common reason was a con-
flict with the soft tissue.
Blood analysis assessed by the concentration of Mg and Ca
demonstrated normal levels at all follow up visits with a Mg con-
centration between 0.70 0 and 1.10 0 mmol/L and a Ca concentra-
tion between 2.20 and 2.65 mmol/L. Moreover, renal function re-
mained stable after 24 and 52 weeks with a normal glomerular
filtration rate (GFR) equal to ∼130 ml/min/1.73 m2 in males and
∼120 ml/min/1.73 m2 in females.
The mean difference in ROM between the operated site and
the non-operated site of the talocrural joint (dorsal flexion/plantar
flexion) was 7°±13° after 6 months and then decreased to 2°±11°
after one year. Additionally, no misalignments of the ankle were
reported.
Between 6 and 12 months, no infections, encapsulation or
screw failure including breakage, loosening or cracking were re-
ported. In all antero-posterior and lateral plane radiographs the
shaft of the screws were still visible after 6 and 12 months. Ra-
diolucent zones localized around the screws were associated with
gas formation (H2 ), considered as a product of the screw degrada-
tion (Fig. 2 and 3). As shown in Fig. 3, these zones are persisted
or sligthly decreased 6 to 12 months (white arrows). An associ-
ated line is observed at the border of the radiolucent zones after
6 and 12 months and is correlated with the formation of dense
cortical-like bone at the interface. After one year of implantation,
radiological disappearance of the screw head was observed in 17
1285
Injury 53 (2022) 1283–1288
patients (90%). As shown in Fig. 2 and 3, all screw heads were ra-
diographically observable after 24 weeks in the medial malleolus.
One year after implantation the head of the screws was mainly re-
sorbed (blue arrows).
Discussion
Hardware removal is mainly performed during the first year af-
ter the primary surgery [14]. Mid-term results, 6 and 12 months af-
ter MM fracture reduction with bioresorbable ZX00 screws exhibit
excellent clinical and functional outcomes without complications.
According to a recent systematic review and meta-analysis includ-
ing eight clinical trials and reviewing a total number of 230 pa-
tients, the estimated complication rate for Mg-based implants was
13.3% [29]. In the current literature a total of five clinical studies
including prospective and retrospective clinical trials investigating
Mg-based alloys implanted in foot ankles are registered and ex-
hibit similar clinical and functional outcomes [30–34]. All of these
studies aimed on the clinical implementation of Mg implants al-
loyed with REEs. Amongst them, compression screws (CS) based on
Mg with yttrium, zirconium and other REEs were used for lateral
malleolar fractures [30] and for biplane chevron MM osteotomy in
the treatment of osteochondral lesions of the talus [33]. Two ret-
rospective studies for MM fracture fixation and reported fracture
union associated to retrieved ankle function without complications
in a follow-up between 12 and 24 months [31,34]. May et al.
(2020) retrospectively reviewed a cohort studying MM fractures.
23 patients were treated with bioresorbable Mg-based screws and
25 patients with Ti screws [34]. A similar therapeutic efficacy
in MM fracture fixation was shown between the two materials.
No Mg-based screws were removed while five patients treated
with Ti screws underwent screw removal 12 - 19 months after
surgery [34]. Xie et al. (2021) explored the clinical use of an al-
loy made with Mg, neomydium, zinc and zirconium for MM frac-
ture fixation. During the one year of follow-up, no infection, fail-
ure of internal fixation, malunion, or other complications were
shown and a similar AOFAS score (90.4±8.9) after one year was
reported [32].
This prospective clinical trial using screws made of Mg and
nutrient elements (Ca and Zn) confirm that this alloying system
presents the same excellent clinical and functional outcomes as
previously shown in other retrospective studies.
During the one year follow-up study, several important results
were found, in particular concerning the bioresorbable behavior of
the Mg-based screws. This bioresorbability can be divided into two
stages: during the early stage up to 24 weeks, ZX00 degradation
is associated with the gradual increase of gas volume around the
V. Herber, V. Labmayr, N.G. Sommer et al. Injury 53 (2022) 1283–1288

Fig. 3. Anteroposterior ankle radiographs of two 45-year-old female patients (A and B) and a 30-year-old male patient (C). From left to right, anteroposterior ankle radiograph
before surgery and after 6 and 12 months. All fractures were stabilized with two Mg-based screws aftre open anatomical reduction. After 6 months, radiolucent zones
corresponding to the product of corrosion are homogeneously localized around the screws (white arrow). After 12 months, the radiolucent zones are still present but
decrease slightly. Screw’s heads are generally resorbed after 12 months (blue arrows).

1286
V. Herber, V. Labmayr, N.G. Sommer et al.
screw and is characterized by the extension of radiolucent areas
[28]; during the second stage between 24 and 52 weeks, the radi-
olucent areas are still present around the srew but the gas evolu-
tion has slightly diminished.
Due to their composition, ZX00 compression screws have the
same radio-opacity as cortical bone. After implantation of Mg in
the physiological environment, it corrodes through electrochemi-
cal and chemical processes. The hydrogen evolution reaction is the
main cathodic reaction during Mg corrosion [35,36]. The hydro-
gen (H2 ) production occurs spontaneously after implantation and
is characterized radiographically by the appearance of radiolucent
zones. After 6 and 12 months, a homogeneous degradation pro-
cess of the screw shafts characterized by radiolucent zones local-
ized around the screws was observed in all patients. To reduce and
control the corrosion rate, various strategies such as purification,
alloying, and surface modification were developed. Xie et al. (2021)
explored the clinical use of calcium phosphate coating on the Mg-
based alloy surface to reduce the degradation products formation
(H2 ) [32]. Similar clinical outcomes were reported, still revealing
radiolucent areas in the radiographic outcomes up to one year af-
ter implantation. Though, further clinical investigations need to be
done, as the cited study included only 9 subjects.
The ZX00 screws used in this study were designed as par-
tially threaded, non-cannulated cortical screws that where used as
compression screws. After radiographical examination at the final
follow-up, the representative radiographs showed that corrosion
occurred predominantly at the head of the Mg screws in approxi-
mately 90% of the patients. This could be due to pronounced blood
supply and shear forces present in the soft tissue area, adjacent to
the screw head, which might lead to accelerated degradation. On
the medial side of the ankle, screw prominence can cause irritation
of the posteriortibialis tendon or other soft-tissue irritation [37]. As
the screw head can cause skin irritations due for instance to shoe
conflict, the resorption of the screw heads after one year is a big
advantage.
One year after implantation of ZX00 screws for MM fracture
fixation, no Mg hardware removal was necessary. Thus, Mg-based
implant can avoid related costs, potential complications and the
associated stress for the patient due to the second stage surgery
for hardware removal. In contrast, in 71% percent of the patients
who received an additional fragment refixation with conventional
Ti implants, a second surgery for implant removal was performed.
In most cases, skin irritation was the reason for conventional im-
plant removal.
This study has some limitations. Following a “bench-to-bedside”
approach, this study is the first investigation of this alloying sys-
tem (made only with nutrient elements) in human beings. A ran-
domized study was not allowed per definitionem, as the safety is
not to be proven in a randomized control study group. Addition-
ally, only 20 patients were included in this clinical trial.
Conclusion
Outcomes after one year reveal excellent PROMs and functional
outcomes after implantation of bioresorbable screws based on Mg
and nutrient elements. The resorbability of the screw heads after
one year could also provide an advantage over conventional bio-
inert implants by avoiding related complications which normally
appear after fracture healing and resumption of daily activities in-
between the month 6 and 12. No Mg hardware removal was nec-
essary up to one year of follow-up suggesting implant safety. Due
to its bioresorbability and therefore the avoidance of (i) hardware
removal surgeries, (ii) related costs and (iii) the reduction of asso-
ciated comorbidities, Mg-based screws as nutrient implant solution
may be a suitable alternative material for future fracture fixation.
1287
Injury 53 (2022) 1283–1288
Declaration of Competing Interest
Valentin Herber, Viktor Labmayr, Nicole G. Sommer, Romy
Marek, Ulrike Wittig, Franz Seibert and Patrick Holweg certify that
they have NO affiliations with or involvement in any organization
or entity with any financial interest (such as honoraria; educa-
tional grants; participation in speakers’ bureaus; membership, em-
ployment, consultancies, stock ownership, or other equity interest;
and expert testimony or patent-licensing arrangements), or non-
financial interest (such as personal or professional relationships,
affiliations, knowledge or beliefs) in the subject matter or materi-
als discussed in this manuscript. Andreas Leithner declares institu-
tional educational grants from Johnson & Johnson, Alphamed, Im-
plantec and Medacta.
Funding/support statement
One of the authors (P.H.) has received funding from LORENZ
BÖHLER Fond.
Acknowledgements
The Laura Bassi Center BRIC (Medical University Graz, Graz,
Austria) support the study by performing the needed preclinical
studies (FFG (Austrian fund)). Bri.Tech GmbH (Austria) supported
the study by knowledge transfer.
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