NCT04113044

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

Clinical Priority Program (CPP) Clinical Outcome Measurement of Fracture Treatment:

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: AO Innovation Translation Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

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 Objectives: To analyse the association between automated, sensor-based patient activity and loading data, and clinical (Patient Reported Outcomes \[PROs\]) and radiographic outcome during fracture healing. II) Recovery Trajectory using PROMIS®: Defining the Recovery Trajectory using PROMIS® to Optimize Decision-making and Outcomes following Extremity Fractures Objectives: 1. To identify the factors predictive of longer term magnitude of limitations after extremity fractures (using PROMs) 2. To assess minimal clinically important difference (MCID) and substantial clinical benefit (SCB) in PROM scores 3. To define recovery trajectories of PROMs i.e. range, normative limits and score thresholds III) Linking PROMIS®: Linking of PROMIS Measures to Legacy Measures in an Orthopaedic Patient Population Objectives: 1. Administer and collect responses to the PROMIS PF/UE and PAIN INT and the four orthopaedic legacy measures in the same group of orthopaedic trauma patients. 2. Apply the methods of item-response theory (IRT) linking to establish a common standardized metric. 3. Develop equations for conversion of a PROMIS PF/UE and PAIN INT score to each of the specified legacy measures and vice-versa.

Conditions

• Hip Fractures
• Tibial Fractures
• Ankle Fractures
• Humeral Fracture, Proximal
• Distal Radius Fracture

Interventions

Type	Name	Description
OTHER	All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics.	All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics.

Timeline

• Start date: 2021-02-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2019-10-02
• Last updated: 2026-03-06

Locations

15 sites across 6 countries: United States, Austria, Colombia, Germany, Netherlands, United Kingdom