Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures

Tibial Fracture Clinical Trial

— FROST  

Official title:

Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures (FROST)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03598530
• Other study ID #: FROST_RP_v3.0
• Status: Active, not recruiting
• Start date: April 4, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fracture of the Tibia Type AO/OTA 42
• Fractures, Bone
• Tibial Fracture
• Tibial Fractures

Intervention

Procedure:
• Surgery
Surgical fracture fixation, using osteosynthesis, including single or multiple staged procedures (e.g. primary External Fixation and later conversion to internal fixation).

Locations

Country	Name	City	State
Belgium	Department of Trauma Surgery, UZ Leuven	Leuven
Germany	University Medical Center Mainz	Mainz
Germany	Medical Faculty LMU Munich	Munich
Germany	University Hospital Münster	Münster
Hong Kong	Queen Mary Hospital	Hong Kong
Korea, Republic of	Korea University Guro Hospital	Seoul
Singapore	Sengkang General Hospital	Singapore
South Africa	Tygerberg Hospital	Cape Town
Switzerland	University Hospital Basel	Basel
Switzerland	University Hospital Zurich	Zuerich
United Kingdom	University Hospitals Coventry & Warwickshire NHS Trust	Coventry
United Kingdom	Leeds General Infirmary University Hospital	Leeds
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	NYU Langone and affiliated Hospitals	New York	New York
United States	NYU Langone Jamaica Hospital Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation	DePuy Synthes

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Hong Kong,  Korea, Republic of,  Singapore,  South Africa,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to bone healing/union	Time elapsed between treatment and union evaluated clinically and radiologically.	6 weeks / 6 months / 12 months / 36 months
Primary	Patient-reported outcome	Change in PROMIS Pain interference (v1.0 - Pain Interference 8a) over the the follow-up period Change in PROMIS: Physical function (mobility) (v2.0 - Physical Function 10b) over the the follow-up period	6 weeks / 6 months / 12 months / 36 months