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

Last updated: March 24, 2025
Sponsor: AO Innovation Translation Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Treatment

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

Clinical Study ID

NCT04113044
CPP Patient Outcome
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 accordingto the Clinical Investigation Plan (CIP)

  • Signed and dated EC/IRB approved written informed consent

Exclusion

Exclusion Criteria:

  • More than 14 days from day of injury to day of surgery / day of nonoperativetreatment decision

  • Patients with multiple fractures

  • Pathological fractures due to cancer

  • Recent history of substance abuse (i.e. recreational drugs, alcohol) that wouldpreclude reliable assessment

  • Pregnancy or women planning to conceive within the study period

  • Patients who are not able to provide independent written informed consent unlessdefined and IRB/IEC-approved procedures for consenting such vulnerable patients arein place

  • Prisoners

  • Participation in any other medical device or medicinal product study within theprevious month that could influence the results of the present study

  • Patients unable to likely achieve anticipated Follow-up (FU)

Study Design

Total Participants: 3500
Treatment Group(s): 1
Primary Treatment: All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics.
Phase:
Study Start date:
February 01, 2021
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Univ.-Klinik für Orthopädie und Traumatologie

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • Wilheminenspital Vienna

    Wien, 1160
    Austria

    Site Not Available

  • Fundación Santa Fe de Bogotá

    Bogotá, 110121
    Colombia

    Active - Recruiting

  • Centrum für Muskuloskeletale Chirurgie (CMSC) Charite - Universitätsmedizin Berlin

    Berlin, 13353
    Germany

    Active - Recruiting

  • University Hospital Freiburg

    Freiburg, 79106
    Germany

    Site Not Available

  • Saarland University Hospital Department of Trauma, Hand and Reconstructive Surgery

    Homburg, 66421
    Germany

    Active - Recruiting

  • Institut für Biomechanik Berufsgenossenschaftliche Unfallklinik Murnau

    Murnau Am Staffelsee, 82418
    Germany

    Active - Recruiting

  • Abteilung für Unfall- und Wiederherstellungschirurgie BG Klinik Tübingen

    Tuebingen, 72076
    Germany

    Site Not Available

  • University Medical Center Groningen

    Groningen, 9700
    Netherlands

    Active - Recruiting

  • Isala Clinics

    Zwolle, 8000
    Netherlands

    Active - Recruiting

  • Barts Health NHS Trust

    London, E14DG
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX39DU
    United Kingdom

    Site Not Available

  • Cedars-Sinai Department of Orthopaedics

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • University of Miami, Jackson Memorial Hospital Ryder Trauma Center

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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

    Austin, Texas 78712
    United States

    Active - Recruiting

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