An observational study in Syndesmotic Injury, Trimalleolar Fracture and Bimalleolar Ankle Fracture, sponsored by Patrick Lukas Holweg, MD. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Patrick Lukas Holweg, MD · Observational
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.
202 studies on the registry are indexed under Ankle Fractures; 44 are open to participants now.
This study's planned enrollment of 20 is below the median of 75 across 42 observational studies indexed under Ankle Fractures.
Browse Ankle Fractures studies →This is the only study on the registry with Patrick Lukas Holweg, MD as lead sponsor.
Compared within Ankle Fractures, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Ankle Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
implant function
Successful temporary maintenance of stable pedicle screw fixation with ZX00 without intraoperative technical problems or change of fixation method.
Time frame: 12 weeks and 1 year postoperatively
pain releave
visual analoge scale
Time frame: baseline, 12 weeks and 1 year postoperatively
functional improvement
AOFAS-Score
Time frame: baseline, 12 weeks and 1 year postoperatively
Subjective performance capacity
FAAM-Score
Time frame: baseline, 12 weeks and 1 year postoperatively
Radiological durability
no secondary displacement on plain radiographs in two planes
Time frame: 12 weeks and 1 year postoperatively
Complication rate
occurrence of mechanical irritation, implant-associated wound healing disorder, or premature material failure
Time frame: 12 weeks and 1 year postoperatively
Osseointegration
radiological assessment of bony consolidation based on CT control
Time frame: 12 weeks and 1 year postoperatively
Reoperation rate
Time frame: 1 year postoperatively
Health economic aspects
(e.g. avoided implant removals / reduced need for hardware removal surgery)
Time frame: 1 year postoperatively
Started Apr 2026 (actual). Primary completion is estimated for May 2029, 37 months after the start.
Of 20 observational studies under Ankle Fractures, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 12. This study's planned 37 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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