Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS® (NCT04113044) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS®
United States, Austria, Colombia1,500 participantsStarted 2021-02-01
Plain-language 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.
Data collection will include underlying disease, treatment details, patient reported outcomes (PROs), anticipated or procedure-related adverse events (i.e. complications), and radiological outcomes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* More than 21 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Go Fit Fast: Radiographic measurements, Patient related outcomes (PROs: PROMIS, HOOS, KOOS,), Loading/Activity pattern analysis
Timeframe: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)