RECRUITING

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Conditions

Hip FracturesTibial FracturesAnkle FracturesHumeral Fracture, ProximalDistal Radius FracturePROHOOSKOOSFAAMPROMISQuickDASHPSEQPAM

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-02-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04113044

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years and older
  2. * Diagnosis of one of, isolated injury
  3. * Hip fracture
  4. * Tibial shaft fracture (with and without associated fibular fracture)
  5. * Ankle/pilon fracture
  6. * Proximal humerus fracture
  7. * Distal radius fracture
  8. * English, German, or Spanish speaking
  9. * Informed consent obtained, i.e.:
  10. * Ability to understand the content of the patient information/ICF
  11. * Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
  12. * Signed and dated EC/IRB approved written informed consent
  1. * More than 14 days from day of injury to day of surgery / day of nonoperative treatment decision
  2. * Patients with multiple fractures
  3. * Pathological fractures due to cancer
  4. * Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
  5. * Pregnancy or women planning to conceive within the study period
  6. * 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
  7. * Prisoners
  8. * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
  9. * Patients unable to likely achieve anticipated Follow-up (FU)

Contacts and Locations

Study Contact

Aleksandra Hodor, PhD
CONTACT
+41 44 200 24 81
aleksandra.hodor@aofoundation.org
Marilyn Heng, MD MPH FRCSC
CONTACT
mheng@mgh.harvard.edu

Principal Investigator

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 Locations (Sites)

Cedars-Sinai Department of Orthopaedics
Los Angeles, California, 90048
United States
University of Miami, Jackson Memorial Hospital Ryder Trauma Center
Miami, Florida, 33136
United States
Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative
Boston, Massachusetts, 02114
United States
The Value Institute / Department of Surgery and Peri-operative Care. Dell Medical School, University of Texas at Austin
Austin, Texas, 78712
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-02-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • PRO
  • HOOS
  • KOOS
  • FAAM
  • PROMIS
  • QuickDASH
  • PSEQ
  • PAM

Additional Relevant MeSH Terms

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