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

AO Innovation Translation Center

Status: Enrolling

Conditions: Hip Fractures; Tibial Fractures; Distal Radius Fracture; Humeral Fracture, Proximal; Ankle Fractures

Treatments: Other: All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics.

Study type: Observational

Funder types: Other

Identifiers

NCT04113044

CPP Patient Outcome

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)