Status:
RECRUITING
Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS®
Lead Sponsor:
AO Innovation Translation Center
Conditions:
Hip Fractures
Tibial Fractures
Eligibility:
All Genders
18+ years
Brief Summary
Prospective data will be collected in approximately 3500 patients (700 per 5 injury groups). Patients will be followed up according to the standard (routine) for up to 1 year after the treatment. Da...
Detailed Description
More in detail this observational study includes the following sub-projects: I) Weight -bearing and Gait Observation for Fully Individualized Treatment and Aftercare Following Surgery and Trauma Obj...
Eligibility Criteria
Inclusion
- Age 18 years and older
- Diagnosis of one of, isolated injury
- Hip fracture
- Tibial shaft fracture (with and without associated fibular fracture)
- Ankle/pilon fracture
- Proximal humerus fracture
- Distal radius fracture
- English, German, or Spanish speaking
- Informed consent obtained, i.e.:
- Ability to understand the content of the patient information/ICF
- Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
- Signed and dated EC/IRB approved written informed consent
Exclusion
- More than 14 days from day of injury to day of surgery / day of nonoperative treatment decision
- Patients with multiple fractures
- Pathological fractures due to cancer
- Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
- Pregnancy or women planning to conceive within the study period
- Patients who are not able to provide independent written informed consent unless defined and IRB/IEC-approved procedures for consenting such vulnerable patients are in place
- Prisoners
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
- Patients unable to likely achieve anticipated Follow-up (FU)
Key Trial Info
Start Date :
February 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
3500 Patients enrolled
Trial Details
Trial ID
NCT04113044
Start Date
February 1 2021
End Date
December 31 2026
Last Update
March 26 2025
Active Locations (15)
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1
Cedars-Sinai Department of Orthopaedics
Los Angeles, California, United States, 90048
2
University of Miami, Jackson Memorial Hospital Ryder Trauma Center
Miami, Florida, United States, 33136
3
Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative
Boston, Massachusetts, United States, 02114
4
The Value Institute / Department of Surgery and Peri-operative Care. Dell Medical School, University of Texas at Austin
Austin, Texas, United States, 78712