Clinical trial NCT03598530: Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures
Official title: Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures (FROST)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Tibial Fracture
Fracture of the Tibia Type AO/OTA 42
Keywords: Fracture fixation
Surgical treatment
Fracture reduction
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: DePuy Synthes
First posted: 2018-07-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients older than 18 years old that present a tibial shaft fracture (type 42 according to the AO/OTA Fracture and Dislocation Classification), resulting from a trauma and not caused by a malignancy, that requires surgical treatment.

Brief summary: Approximately 1000 patients presenting with tibial shaft fractures (AO type 42) will be enrolled prospectively in this registry. All patients are treated and followed at 6 weeks, 6 months and 1 year postoperative always following the local standard of care (routine) visit schedule up to 36 months if required.

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


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older at the time of the injury
* 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:

* Pathological fracture caused by malignancy
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Primary outcomes:
measure: Patient-reported outcome
timeFrame: 6 weeks / 6 months / 12 months / 36 months
Secondary outcomes:
Other outcomes:
measure: Time to bone healing/union
timeFrame: 6 weeks / 6 months / 12 months / 36 months
Locations:
city: New York
country: United States
facility: NYU Langone and affiliated Hospitals
state: New York
city: New York
country: United States
facility: NYU Langone Jamaica Hospital Medical Center
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Leuven
country: Belgium
facility: Department of Trauma Surgery, UZ Leuven
city: Mainz
country: Germany
facility: University Medical Center Mainz
city: Munich
country: Germany
facility: Medical Faculty LMU Munich
city: Münster
country: Germany
facility: University Hospital Münster
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Singapore
country: Singapore
facility: Sengkang General Hospital
city: Cape Town
country: South Africa
facility: Tygerberg Hospital
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Zuerich
country: Switzerland
facility: University Hospital Zurich
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry & Warwickshire NHS Trust
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary University Hospital
Study officials:
affiliation: Department of Trauma Surgery, UZ Leuven
name: Willem J Metsemakers, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.