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Conditions studied: Hip Fractures, Tibial Fractures, Ankle Fractures, Humeral Fracture, Proximal, Distal Radius Fracture

In brief

Prospective data will be collected in approximately 3500 patients (700 per 5 injury groups). Patients will be followed up according to the standard (routine) for up to 1 year after the treatment. Data collection will include underlying disease, treatment details, patient reported outcomes (PROs), anticipated or procedure-related adverse events (i.e. complications), and radiological outcomes.

Key facts

Study ID

NCT04113044

Run by

AO Innovation Translation Center

People needed

1500

Starts

2021-02-01

Expected to finish

2026-12-31

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years and older
• Diagnosis of one of, isolated injury
• Hip fracture
• Tibial shaft fracture (with and without associated fibular fracture)
• Ankle/pilon fracture
• Proximal humerus fracture
• Distal radius fracture
• English, German, or Spanish speaking
• Informed consent obtained, i.e.:
• Ability to understand the content of the patient information/ICF
• Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
• Signed and dated EC/IRB approved written informed consent

You may not qualify if…

• More than 21 days from day of injury to day of surgery / day of nonoperative treatment decision
• Patients with multiple fractures
• Pathological fractures due to cancer
• Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
• Pregnancy or women planning to conceive within the study period
• Patients who are not able to provide independent written informed consent unless defined and IRB/IEC-approved procedures for consenting such vulnerable patients are in place
• Prisoners
• Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
• Patients unable to likely achieve anticipated Follow-up (FU)

Where it is running

• Cedars-Sinai Department of Orthopaedics — Los Angeles, California, United States
• University of Miami, Jackson Memorial Hospital Ryder Trauma Center — Miami, Florida, United States
• Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative — Boston, Massachusetts, United States
• The Value Institute / Department of Surgery and Peri-operative Care. Dell Medical School, University of Texas at Austin — Austin, Texas, United States
• Univ.-Klinik für Orthopädie und Traumatologie — Innsbruck, Austria
• Fundación Santa Fe de Bogotá — Bogotá, Colombia
• Centrum für Muskuloskeletale Chirurgie (CMSC) Charite - Universitätsmedizin Berlin — Berlin, Germany
• University Hospital Freiburg — Freiburg im Breisgau, Germany
• Saarland University Hospital Department of Trauma, Hand and Reconstructive Surgery — Homburg, Germany
• Institut für Biomechanik Berufsgenossenschaftliche Unfallklinik Murnau — Murnau am Staffelsee, Germany
• Abteilung für Unfall- und Wiederherstellungschirurgie BG Klinik Tübingen — Tübingen, Germany
• University Medical Center Groningen — Groningen, Netherlands
• Isala Clinics — Zwolle, Netherlands
• Barts Health NHS Trust — London, United Kingdom
• Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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