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

AO Innovation Translation Center3,500 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

3,500

Conditions

Hip Fractures Tibial Fractures

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (15)

Cedars-Sinai Department of Orthopaedics

Los Angeles, California, United States

RECRUITING

University of Miami, Jackson Memorial Hospital Ryder Trauma Center

Miami, Florida, United States

RECRUITING

Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative

Boston, Massachusetts, United States

RECRUITING

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

Austin, Texas, United States

RECRUITING

Univ.-Klinik für Orthopädie und Traumatologie

Innsbruck, Austria

RECRUITING

Fundación Santa Fe de Bogotá

Bogotá, Colombia

RECRUITING

Centrum für Muskuloskeletale Chirurgie (CMSC) Charite - Universitätsmedizin Berlin

Berlin, Germany

RECRUITING

University Hospital Freiburg

Freiburg im Breisgau, Germany

NOT_YET_RECRUITING

Saarland University Hospital Department of Trauma, Hand and Reconstructive Surgery

Homburg, Germany

RECRUITING

Institut für Biomechanik Berufsgenossenschaftliche Unfallklinik Murnau

Murnau am Staffelsee, Germany

RECRUITING

...and 5 more locations

Outcomes

Primary Outcomes

Go Fit Fast: Radiographic measurements, Patient related outcomes (PROs: PROMIS, HOOS, KOOS,), Loading/Activity pattern analysis

* Radiographic measurements o Healing (Radiographic Union Score in Tibia Fractures \[RUST\]/ Radiographic Union Score in Hip Fractures \[RUSH\]) * Patient related outcomes * Patient Reported Outcome Measurement Information System (PROMIS): Physical Function (PF)/Pain Interference * Hip Disability and Osteoarthritis Outcome Score (HOOS) (assessing short- and long-term symptoms and function in hip injuries; the lower score indicates higher symptoms) * Knee Injury and Osteoarthritis Outcome Score (KOOS) (assessing short- and long-term symptoms and function in knee injuries; the lower score indicates higher symptoms) * Loading/Activity pattern analysis: * Number of steps with weight-bearing \>80% body-weight (weight in kg) * pressure distribution \[N/cm2\] * center of pressure \[mm\] * ground reaction forces \[N\] * temporal and spatial parameters (time spent during gait \[min\], stance time \[s\], swing time \[s\], double support time \[s\], cadence \[r/min\], cycle time \[s\])

Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

Recovery Trajectories PROMIS/Linking PROMIS: PROs: PROMIS, HOOS, KOOS, QuickDASH, FAAM

PROs that measure physical limitations: * PROMIS PF (10 questions about physical function/mobility from self-care to strenuous activities; a higher score indicates a better self-reported capability) * PROMIS Upper Extremity (UE) (7 questions assessing arm and hand specific limitations, e.g. difficulty writing, lifting heavy objects; a higher score indicates a better function) * Disabilities of the Arm, Shoulder, and Hand (QuickDASH) (11 questions assessing outcomes in upper extremity disorders; a higher score indicates a greater disability) * HOOS * KOOS * Foot and Ankle Ability Measure (FAAM) (21 items of activities of daily living and 8 items on a Sports subscale. A higher score represent a higher level of physical function) * PROMIS Global Health (10 questions assessing physical health, mental health, and social health; a higher score indicates a better general health)

Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)

Secondary Outcomes

PROMIS Pain Interference

PROMIS Pain Interference (8 questions) assesses the impact of pain on common activities of daily life including social, cognitive, emotional, physical, and recreational aspects. The higher score represents a higher pain level