Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures
- Conditions
- Tibial FractureFracture of the Tibia Type AO/OTA 42
- Registration Number
- NCT03598530
- Lead Sponsor
- AO Clinical Investigation and Publishing Documentation
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient-reported outcome 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
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
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Sengkang General Hospital
🇸🇬Singapore, Singapore
Scroll for more (5 remaining)NYU Langone and affiliated Hospitals🇺🇸New York, New York, United States