Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures (FROST)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tibial Fracture
- Sponsor
- AO Clinical Investigation and Publishing Documentation
- Enrollment
- 1000
- Locations
- 15
- Primary Endpoint
- Patient-reported outcome
- Status
- Active, not recruiting
- Last Updated
- 8 months ago
Overview
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
Investigators
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
Outcomes
Primary Outcomes
Patient-reported outcome
Time Frame: 6 weeks / 6 months / 12 months / 36 months
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