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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04113044
• Other study ID #: CPP Patient Outcome
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: AO Innovation Translation Center
• Contact: Aleksandra Hodor, PhD
• Phone: +41 44 200 24 81
• Email: aleksandra.hodor[@]aofoundation.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ankle Fractures
• Distal Radius Fracture
• Fractures, Bone
• Hip Fractures
• Humeral Fracture, Proximal
• Humeral Fractures
• Radius Fractures
• Shoulder Fractures
• Tibial Fractures
• Wrist Fractures

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Austria	Univ.-Klinik für Orthopädie und Traumatologie	Innsbruck
Colombia	Fundación Santa Fe de Bogotá	Bogotá
Germany	Centrum für Muskuloskeletale Chirurgie (CMSC) Charite - Universitätsmedizin Berlin	Berlin
Germany	University Hospital Freiburg	Freiburg
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	Tuebingen
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford
United States	The Value Institute / Department of Surgery and Peri-operative Care. Dell Medical School, University of Texas at Austin	Austin	Texas
United States	Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative	Boston	Massachusetts
United States	Cedars-Sinai Department of Orthopaedics	Los Angeles	California
United States	University of Miami, Jackson Memorial Hospital Ryder Trauma Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AO Innovation Translation Center

Countries where clinical trial is conducted

United States,  Austria,  Colombia,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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])	from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Primary	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)	from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Secondary	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	from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
Secondary	PROMIS Depression	PROMIS Depression assesses negative mood (sadness, guilt), views of self (worthlessness, self-criticism) and diminished positive affect and engagement (loss of interest) within the previous week. The higher score represents higher depression level	from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
Secondary	PROMIS Anxiety	PROMIS Anxiety assesses levels of anxiety through measuring aspects of fear (e.g. fearfulness, feelings of panic), anxious misery (e.g. worry, dread), hyperarousal (e.g. tension, nervousness, restless) and some somatic symptoms related to arousal (e.g. dizziness). The higher score represent the higher level of anxiety	from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
Secondary	PROMIS Ability to Participate in Social Roles and Activities	PROMIS Ability to Participate in Social Roles and Activities item bank assesses the perceived ability to perform one's usual social roles and activities. The higher score represents better ability for social roles	from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
Secondary	Pain Self-Efficacy Questionnaire (PSEQ)-2	PSEQ-2 assesses adaptive coping strategy and the confidence one can achieve one's goals in spite of pain. Items are scored on a 7-point Likert scale and added to form a total score ranging from 0 to 12, with higher scores indicating greater self-efficacy	from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
Secondary	Patient Activation Measure (PAM)-10	PAM-10 assesses activation and the personal and psychological competencies. PAM segments individuals into one of four activation levels along an empirically derived 100-point scale. Individuals in the highest activation level are proactive with their health, have developed strong self-management skills, and are resilient in times of stress or change.	from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
Secondary	Cognitive assessment	The MiniCog is a 3-minute instrument assessing cognitive impairment. It consists of two components, a 3-item recall test for memory and a simply scored clock drawing test. A total score ranges from 0 to 5. A score of zero, one or two out of five points in total, indicates a concern in cognitive functioning.	Pre-treatment
Secondary	Mobility Scores	Parker Mobility Scale assess the patient's ability to perform indoor walking, outdoor walking, and shopping before the fracture. A score ranges between 0 and 3 (0 = not at all, 1 = with help from another person, 2 = with an aid, and 3 = no difficulty and no aid) for each function, resulting in a total score ranging from 0 (no walking ability at all) to 9 (fully independent).	Pre-treatment