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

Description

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.

Conditions

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

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Study Overview

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Study Details

Study 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.

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

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

Condition
Hip Fractures
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Department of Orthopaedics, Los Angeles, California, United States, 90048

Miami

University of Miami, Jackson Memorial Hospital Ryder Trauma Center, Miami, Florida, United States, 33136

Boston

Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative, Boston, Massachusetts, United States, 02114

Austin

The Value Institute / Department of Surgery and Peri-operative Care. Dell Medical School, University of Texas at Austin, Austin, Texas, United States, 78712

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AO Innovation Translation Center,

Marilyn Heng, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative

Prakash Jayakumar, PRINCIPAL_INVESTIGATOR, Dell Medical School, University of Texas at Austin

Tim Pohlemann, PRINCIPAL_INVESTIGATOR, Saarland University Hospital

Study Record Dates

2026-12-31