Background
Methods/design
Study objectives
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Increase knowledge and evidence with respect to the epidemiology and treatment concepts of TSFs worldwide by collecting prospective data in a structured and systematic manner.
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Identify risk factors (e.g., injury, patient, or treatment) for favorable and unfavorable outcomes and complications.
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Allow data mining to gather evidence to optimize the clinical decision-making process, particularly to (i) develop strategies that intend to prevent musculoskeletal complications and (ii) generate hypotheses for future studies.
Study design
Department of Trauma Surgery, University Hospitals Leuven, Leuven, Belgium | PI (PCI): Willem-Jan Metsemakers |
Department of Trauma-, Hand- and Reconstructive Surgery, University Hospital Muenster, Muenster, Germany | PI (Co-PCI): Michael Raschke |
Department of Trauma Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands | PI (Co-PCI): Michael H. J. Verhofstad |
Department of Orthopaedic and Trauma Surgery, University Hospital Basel, Basel, Switzerland | PI Mario Morgenstern |
Division of Orthopaedics, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg Hospital, Cape Town, South Africa | PI Nando Ferreira |
Department of General Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Munich, Germany | PI Christian Kammerlander |
Department of Orthopaedic Surgery and Rehabilitation, Vanderbilt University Medical Center, Nashville, TN, United States of America | PI William T. Obremskey |
Department of Orthopedic Surgery, NYU Langone Orthopedic Hospital, New York, NY, United States of America | PI Kenneth A. Egol |
Department of Orthopaedic Surgery, NYU Langone Orthopedic Hospital and Jamaica Hospital Medical Center, New York, NY, United States of America | PI Sanjit Konda |
Department of Orthopaedic Surgery, Korea University College of Medicine, Guro Hospital, Guro-gu, Seoul, Republic of Korea | PI Jong-Keon Oh |
Department of Orthopaedic Surgery, Sengkang General Hospital, Singapore | PI Wong Merng Koon |
Department of Trauma, UniversitätsSpital Zürich, University of Zurich, Zurich, Switzerland | PI Hans-Christoph Pape |
Academic Department of Trauma and Orthopaedics, School of Medicine, University of Leeds, Leeds General Infirmary, Leeds, United Kingdom (Planned New Site) | PI Peter V. Giannoudis |
Department of Orthopaedics and Traumatology, University Medical Center, Johannes Gutenberg-University, Mainz, Germany (Planned New Site) | PI Eric Hanke |
Department of Orthopaedics and Traumatology, Queen Mary Hospital, University of Hong Kong, Pokfulam, Hong Kong (Planned New Site) | PI Christian Fang |
Department of Surgery, Franciscus Gasthuis en Vlietland Hospital, Rotterdam, The Netherlands (Planned New Site) | PI Taco M. A. L. Klem |
Department of Orthopedics, Elisabeth-TweeSteden Hospital, Tilburg, Netherlands (Planned New Site) | PI Kirsten Kortram |
Participants
Sample size estimation
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Inclusion criteria1.Aged ≥18 years at the time of the injury.2.The diagnosis of a primary TSF, a fracture type 42, according to the Arbeitsgemeinschaft für Osteosynthesefragen (AO)/Orthopaedic Trauma Association (OTA) Fracture and Dislocation Classification (Fig. 1), that will be treated operatively as part of the standard of care.3.Informed consent will be obtained based on:a.The ability of the patient or an assigned representative to understand the content of the patient information/Informed Consent Form (ICF).b.Signed and dated Institutional Review Board (IRB)/Ethics Committee (EC)-approved written informed consent.
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Exclusion criteria1.Pathological fractures caused by malignancy.2.Patients participating in any other medical device or medicinal product study within the previous month that could influence the results of the present study.3.Patients who cannot provide independent written informed consent unless defined, and IRIR/EC-approved procedures for consenting such vulnerable patients are in place.
Procedures
Recruitment
Baseline parameters
Interventions and study procedures
Baseline | Treatment | Post-treatment visit 1a | Post-treatment visit 2a | Post-treatment visit 3a | Additional Post-treatment visit(s)a | |
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– | Day 0 | 6 weeks (target 42 days: range 14 to 105) | 6 months (target 183 days; range 106 to 260) | 12 months (target 365 days, range 261 to 456) | Up to 36 months | |
Eligibility | X | |||||
Patient information/consent | Xb | |||||
Demographics | X | |||||
Medical history and pre-treatment values | X | |||||
Injury(s) details | X | |||||
Treatment details | Xc | |||||
Clinical outcome(s) | X | X | X | X | ||
Patient-reported outcome(s) | ||||||
PROMIS: Global Health | X | X | X | X | X | |
PROMIS: Physical Function | X | X | X | X | X | |
PROMIS: Pain Interference | X | X | X | X | ||
Pain numeric rating scale (NRS) | X | X | X | X | ||
Complications | X | X | X | X | ||
Images and/or other clinical pictures | Xd | Xd | Xd | Xd | Xd | Xd |
Outcome measures
Data collection and management
Premature termination
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The patient withdraws informed consent
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Screening failure (patient not meeting the eligibility criteria)
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Investigator’s discretion (e.g., patient noncompliance with the registry plan)
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Sponsor’s decision
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Unknown/lost to FU
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Death