Overview
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.
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
-
- 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.
Eligibility
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)