Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS®
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ankle Fractures
- Distal Radius Fracture
- Hip Fractures
- Humeral Fracture, Proximal
- Tibial Fractures
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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,...
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: To identify the factors predictive of longer term magnitude of limitations after extremity fractures (using PROMs) To assess minimal clinically important difference (MCID) and substantial clinical benefit (SCB) in PROM scores 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: 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. Apply the methods of item-response theory (IRT) linking to establish a common standardized metric. Develop equations for conversion of a PROMIS PF/UE and PAIN INT score to each of the specified legacy measures and vice-versa.
Tracking Information
- NCT #
- NCT04113044
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Marilyn Heng Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative Principal Investigator: Prakash Jayakumar Dell Medical School, University of Texas at Austin Principal Investigator: Tim Pohlemann Saarland University Hospital