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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04113044
Study type	Observational
Source	AO Innovation Translation Center
Contact	Aleksandra Hodor, PhD
Phone	+41 44 200 24 81
Email	aleksandra.hodor@aofoundation.org
Status	Recruiting
Phase
Start date	February 1, 2021
Completion date	December 31, 2026

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.