Clinical trial NCT04113044: Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS®
Official title: Clinical Priority Program (CPP) Clinical Outcome Measurement of Fracture Treatment:
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Fractures
Tibial Fractures
Ankle Fractures
Humeral Fracture, Proximal
Distal Radius Fracture
Keywords: PRO
HOOS
KOOS
FAAM
PROMIS
QuickDASH
PSEQ
PAM
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over 18 who have have suffered an isolated fracture of one of the following five bones: 1. proximal femur (hip); 2. tibial shaft (shin bone); 3. ankle; 4. proximal humerus (shoulder); and 5: distal radius ( wrist)

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Go Fit Fast: Radiographic measurements, Patient related outcomes (PROs: PROMIS, HOOS, KOOS,), Loading/Activity pattern analysis
timeFrame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
measure: Recovery Trajectories PROMIS/Linking PROMIS: PROs: PROMIS, HOOS, KOOS, QuickDASH, FAAM
timeFrame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Secondary outcomes:
measure: PROMIS Pain Interference
timeFrame: from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
measure: PROMIS Depression
timeFrame: from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
measure: PROMIS Anxiety
timeFrame: from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
measure: PROMIS Ability to Participate in Social Roles and Activities
timeFrame: from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
measure: Pain Self-Efficacy Questionnaire (PSEQ)-2
timeFrame: from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
measure: Patient Activation Measure (PAM)-10
timeFrame: from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
measure: Cognitive assessment
timeFrame: Pre-treatment
measure: Mobility Scores
timeFrame: Pre-treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Department of Orthopaedics
state: California
city: Miami
country: United States
facility: University of Miami, Jackson Memorial Hospital Ryder Trauma Center
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative
state: Massachusetts
city: Austin
country: United States
facility: The Value Institute / Department of Surgery and Peri-operative Care. Dell Medical School, University of Texas at Austin
state: Texas
city: Innsbruck
country: Austria
facility: Univ.-Klinik für Orthopädie und Traumatologie
city: Bogotá
country: Colombia
facility: Fundación Santa Fe de Bogotá
city: Berlin
country: Germany
facility: Centrum für Muskuloskeletale Chirurgie (CMSC) Charite - Universitätsmedizin Berlin
city: Freiburg
country: Germany
facility: University Hospital Freiburg
city: Homburg
country: Germany
facility: Saarland University Hospital Department of Trauma, Hand and Reconstructive Surgery
city: Murnau Am Staffelsee
country: Germany
facility: Institut für Biomechanik Berufsgenossenschaftliche Unfallklinik Murnau
city: Tuebingen
country: Germany
facility: Abteilung für Unfall- und Wiederherstellungschirurgie BG Klinik Tübingen
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Zwolle
country: Netherlands
facility: Isala Clinics
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
Study officials:
affiliation: Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative
name: Marilyn Heng
role: PRINCIPAL_INVESTIGATOR
affiliation: Dell Medical School, University of Texas at Austin
name: Prakash Jayakumar
role: PRINCIPAL_INVESTIGATOR
affiliation: Saarland University Hospital
name: Tim Pohlemann
role: PRINCIPAL_INVESTIGATOR
References: