Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures
NCT ID: NCT03598530
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1000 participants
OBSERVATIONAL
2019-04-04
2025-12-31
Brief Summary
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Data collection includes patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (i.e. complications) and their corresponding treatment
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Tibial Shaft Fracture
Patients sustaining a tibial shaft fracture (AO/OTA type 42) that requires surgery
Surgery
Surgical fracture fixation, using osteosynthesis, including single or multiple staged procedures (e.g. primary External Fixation and later conversion to internal fixation).
Interventions
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Surgery
Surgical fracture fixation, using osteosynthesis, including single or multiple staged procedures (e.g. primary External Fixation and later conversion to internal fixation).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of a primary tibial shaft fracture (fracture type 42 according to the AO/OTA Fracture and Dislocation Classification) that will be treated operatively as part of standard of care
Exclusion Criteria
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
18 Years
ALL
No
Sponsors
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DePuy Synthes
INDUSTRY
AO Clinical Investigation and Publishing Documentation
OTHER
Responsible Party
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Principal Investigators
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Willem J Metsemakers, Prof.
Role: PRINCIPAL_INVESTIGATOR
Department of Trauma Surgery, UZ Leuven
Locations
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NYU Langone and affiliated Hospitals
New York, New York, United States
NYU Langone Jamaica Hospital Medical Center
New York, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Department of Trauma Surgery, UZ Leuven
Leuven, , Belgium
University Medical Center Mainz
Mainz, , Germany
Medical Faculty LMU Munich
Munich, , Germany
University Hospital Münster
Münster, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
Sengkang General Hospital
Singapore, , Singapore
Tygerberg Hospital
Cape Town, , South Africa
Korea University Guro Hospital
Seoul, , South Korea
University Hospital Basel
Basel, , Switzerland
University Hospital Zurich
Zurich, , Switzerland
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, , United Kingdom
Leeds General Infirmary University Hospital
Leeds, , United Kingdom
Countries
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References
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Metsemakers WJ, Kortram K, Ferreira N, Morgenstern M, Joeris A, Pape HC, Kammerlander C, Konda S, Oh JK, Giannoudis PV, Egol KA, Obremskey WT, Verhofstad MHJ, Raschke M; F.R.O.S.T. Study Group. Fracture-related outcome study for operatively treated tibia shaft fractures (F.R.O.S.T.): registry rationale and design. BMC Musculoskelet Disord. 2021 Jan 9;22(1):57. doi: 10.1186/s12891-020-03930-x.
Other Identifiers
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FROST_RP_v3.0
Identifier Type: -
Identifier Source: org_study_id
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