Syndesmotic InjuryMgSyndesmoseNCT07901205
Use of Bioresorbable Magnesium Set Screws in Syndesmotic Injuries: a Pilot Study
An observational study of Syndesmotic Injury and Trimalleolar Fracture, run by Patrick Lukas Holweg, MD at 1 site in Austria.
Trial summary
The primary aim of this prospective single-center pilot study is to evaluate the implant function of the bioresorbable magnesium set screw (ZX00) for the surgical fixation of the syndesmosis in isolated syndesmotic injuries as well as in bi- and trimalleolar fractures after 12 weeks and 1 year postoperatively. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Syndesmotic Injury, Trimalleolar Fracture, Bimalleolar Ankle Fracture
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 19 Apr 2026to May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated surgically at the University Clinic for Orthopedics and Traumatology for an isolated syndesmotic injury or a bi- or trimalleolar fracture with associated syndesmotic instability.
Who may be able to join
- Minimum age 18 years
- Isolated syndesmotic injury or bi-/trimalleolar fracture with syndesmotic injury
- Consent to participate in the study
Who cannot join
- Inadequate trauma, diagnosed osteoporosis, or osteopenic bone structure
- Polytrauma
- Previous surgical treatment of the syndesmosis
- Advanced post-traumatic osteoarthritis or pre-existing degenerative or inflammatory diseases of the ankle joint
- Underlying conditions (morbid obesity, diabetes mellitus, peripheral vascular disease, fungal foot infection, peripheral neuropathy, rheumatic diseases, autoimmune diseases)
- Systemic corticosteroid therapy for more than 3 months
- Pregnancy and breastfeeding
- Inability or unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department of Orthopaedics and Trauma, Medical University of Graz
Graz, Styria, 8043
Patrick Holweg, PD DDr., +43 316 385 82155, p.holweg@medunigraz.at
About this study
Official title: Einsatz Von Bioresorbierbaren Magnesium-Stellschrauben Bei Syndesmosenverletzungen: Eine Pilotstudie
The primary aim of this prospective single-center pilot study is to evaluate the implant function of the bioresorbable magnesium set screw (ZX00) for the surgical fixation of the syndesmosis in isolated syndesmotic injuries as well as in bi- and trimalleolar fractures after 12 weeks and 1 year postoperatively.
Participants will be routinely operated due to a isolated syndesmotic injury at the department of orthopaedics and trauma. For study purposes patients were asked to complete three questionnaires (NRS, AOFAS, FAAM) at baseline visit, 2, 4, 6, 12 weeks and 12 months follow up. To assess implant integration and resorption kinetics, a CT scan will be performed after 12 weeks and after 1 year.
- Conditions
- Syndesmotic Injury, Trimalleolar Fracture, Bimalleolar Ankle Fracture, Osteosynthesis, Magnesium
- Medical subject headings
- Ankle Injuries, Ankle Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
implant function
Successful temporary maintenance of stable pedicle screw fixation with ZX00 without intraoperative technical problems or change of fixation method.
Measured: 12 weeks and 1 year postoperatively
Secondary outcomes (8)
pain releave
visual analoge scale
Measured: baseline, 12 weeks and 1 year postoperatively
functional improvement
AOFAS-Score
Measured: baseline, 12 weeks and 1 year postoperatively
Subjective performance capacity
FAAM-Score
Measured: baseline, 12 weeks and 1 year postoperatively
Radiological durability
no secondary displacement on plain radiographs in two planes
Measured: 12 weeks and 1 year postoperatively
Complication rate
occurrence of mechanical irritation, implant-associated wound healing disorder, or premature material failure
Measured: 12 weeks and 1 year postoperatively
Osseointegration
radiological assessment of bony consolidation based on CT control
Measured: 12 weeks and 1 year postoperatively
Reoperation rate
Measured: 1 year postoperatively
Health economic aspects
(e.g. avoided implant removals / reduced need for hardware removal surgery)
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start19 Apr 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syndesmotic InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patrick Lukas Holweg, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Bioretec Ltd.
- Responsible party
- Sponsor-investigator, Patrick Lukas Holweg, MD, Medical University of Graz
- Investigators
- Patrick Holweg, PD DDr., Principal investigator, Department of Orthopaedics and Trauma, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901205
- Sponsor's protocol ID
- 1166/2025
- Acronym
- MgSyndesmose
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Einsatz Von Bioresorbierbaren Magnesium-Stellschrauben Bei Syndesmosenverletzungen: Eine Pilotstudie
- ClinicalTrials.gov ID
- NCT07901205
- Acronym / sponsor ID
- MgSyndesmose / 1166/2025
- Conditions
- Syndesmotic Injury, Trimalleolar Fracture, Bimalleolar Ankle Fracture, Osteosynthesis, Magnesium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Patrick Lukas Holweg, MDUniversity, hospital or other
- Collaborators
- Bioretec Ltd.
- Study start
- 19 Apr 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this prospective single-center pilot study is to evaluate the implant function of the bioresorbable magnesium set screw (ZX00) for the surgical fixation of the syndesmosis in isolated syndesmotic injuries as well as in bi- and trimalleolar fractures after 12 weeks and 1 year postoperatively.
Participants will be routinely operated due to a isolated syndesmotic injury at the department of orthopaedics and trauma. For study purposes patients were asked to complete three questionnaires (NRS, AOFAS, FAAM) at baseline visit, 2, 4, 6, 12 weeks and 12 months follow up. To assess implant integration and resorption kinetics, a CT scan will be performed after 12 weeks and after 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated surgically at the University Clinic for Orthopedics and Traumatology for an isolated syndesmotic injury or a bi- or trimalleolar fracture with associated syndesmotic instability.
Key inclusion criteria (3 listed)
- Minimum age 18 years
- Isolated syndesmotic injury or bi-/trimalleolar fracture with syndesmotic injury
- Consent to participate in the study
Key exclusion criteria (8 listed)
- Inadequate trauma, diagnosed osteoporosis, or osteopenic bone structure
- Polytrauma
- Previous surgical treatment of the syndesmosis
- Advanced post-traumatic osteoarthritis or pre-existing degenerative or inflammatory diseases of the ankle joint
- Underlying conditions (morbid obesity, diabetes mellitus, peripheral vascular disease, fungal foot infection, peripheral neuropathy, rheumatic diseases, autoimmune diseases)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
implant function
Time frame: 12 weeks and 1 year postoperatively
Successful temporary maintenance of stable pedicle screw fixation with ZX00 without intraoperative technical problems or change of fixation method.
8 secondary outcomes
pain releave
Time frame: baseline, 12 weeks and 1 year postoperatively
functional improvement
Time frame: baseline, 12 weeks and 1 year postoperatively
Subjective performance capacity
Time frame: baseline, 12 weeks and 1 year postoperatively
Radiological durability
Time frame: 12 weeks and 1 year postoperatively
Complication rate
Time frame: 12 weeks and 1 year postoperatively
Osseointegration
Time frame: 12 weeks and 1 year postoperatively
Reoperation rate
Time frame: 1 year postoperatively
Health economic aspects
Time frame: 1 year postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Related trials for Syndesmotic Injury
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Computed Tomography With Stress Maneuvers for Evaluation of Distal Tibiofibular Syndesmosis Instability (CTMETS)
Ankle Sprain
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Dynamic Fixation for Complex Ankle Fractures With Syndesmotic Diastasis.
Ankle Fractures, Syndesmotic Injury of the Ankle
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Stability of Distal Tibiofibular Syndesmosis With or Without Fixation of Posterior Fragments in Bimalleolar Fractures
Ankle Fractures, Osteoarthritis, Ankle
Recruiting
Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
Ankle Fractures, Bimalleolar Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Holweg, PD DDr. principal investigator
Department of Orthopaedics and Trauma, Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syndesmotic Injury and Trimalleolar Fracture, run by Patrick Lukas Holweg, MD at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Holweg, OA PD DDr. (+43 316 385 82155, p.holweg@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
implant function (time frame: 12 weeks and 1 year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.