Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS®
NCT ID: NCT04113044
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3500 participants
OBSERVATIONAL
2021-02-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics.
All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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AO Innovation Translation Center
OTHER
Responsible Party
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Principal Investigators
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Marilyn Heng
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative
Prakash Jayakumar
Role: PRINCIPAL_INVESTIGATOR
Dell Medical School, University of Texas at Austin
Tim Pohlemann
Role: PRINCIPAL_INVESTIGATOR
Saarland University Hospital
Locations
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Cedars-Sinai Department of Orthopaedics
Los Angeles, California, United States
University of Miami, Jackson Memorial Hospital Ryder Trauma Center
Miami, Florida, United States
Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative
Boston, Massachusetts, United States
The Value Institute / Department of Surgery and Peri-operative Care. Dell Medical School, University of Texas at Austin
Austin, Texas, United States
Univ.-Klinik für Orthopädie und Traumatologie
Innsbruck, , Austria
Fundación Santa Fe de Bogotá
Bogotá, , Colombia
Centrum für Muskuloskeletale Chirurgie (CMSC) Charite - Universitätsmedizin Berlin
Berlin, , Germany
University Hospital Freiburg
Freiburg im Breisgau, , Germany
Saarland University Hospital Department of Trauma, Hand and Reconstructive Surgery
Homburg, , Germany
Institut für Biomechanik Berufsgenossenschaftliche Unfallklinik Murnau
Murnau am Staffelsee, , Germany
Abteilung für Unfall- und Wiederherstellungschirurgie BG Klinik Tübingen
Tübingen, , Germany
University Medical Center Groningen
Groningen, , Netherlands
Isala Clinics
Zwolle, , Netherlands
Barts Health NHS Trust
London, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Countries
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Central Contacts
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Marilyn Heng, MD MPH FRCSC
Role: CONTACT
Facility Contacts
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Mark Vrahas
Role: primary
Neal Chen, MD MPH FRCSC
Role: primary
Prakash Jayakumar, MBBS MRCS
Role: primary
Rohit Arora
Role: primary
Rodrigo Pesanez Hoyos
Role: primary
Sven Maerdian
Role: primary
Martin Jaeger
Role: primary
Tim Pohlemann
Role: primary
Peter Augat
Role: primary
Stefan Doebele
Role: primary
Livio DiMascio
Role: primary
Other Identifiers
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CPP Patient Outcome
Identifier Type: -
Identifier Source: org_study_id
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