Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS®

Launched by AO INNOVATION TRANSLATION CENTER · Sep 30, 2019

Keywords

ClinConnect Summary

The "Go Fit Fast" clinical trial is studying how patients recover from different types of fractures, including hip, tibial (shin), ankle, humeral (upper arm), and distal radius (wrist) fractures. The researchers will collect information from about 3,500 patients, following them for up to a year after their treatment to see how well they heal and return to their daily activities. They want to learn about the patients' health conditions, the treatments they received, any complications that might occur, and how patients feel about their recovery.

To participate in this study, individuals must be 18 years or older and have one of the specific fractures mentioned. They should be able to speak English, German, or Spanish and provide informed consent, which means they understand the study and agree to take part. Participants can expect to share information about their health and recovery experiences, and their progress will be monitored regularly. It's important to know that those with multiple fractures, certain health issues, or who are pregnant cannot join the study. This trial aims to help improve recovery for patients with these injuries.

Gender

ALL

Eligibility criteria

• 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 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)