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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hip Fractures; Tibial Fractures; Distal Radius Fracture; Ankle Fractures; Humeral Fracture, Proximal
• Intervention / Treatment: Other: All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics.

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.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Univ.-Klinik für Orthopädie und Traumatologie
• Colombia
  • Bogotá, Colombia, 110121
    • Fundacion Santa Fe de Bogota
• Germany
  • Berlin, Germany, 13353
    • Centrum für Muskuloskeletale Chirurgie (CMSC) Charite - Universitätsmedizin Berlin
  • Freiburg im Breisgau, Germany, 79106
    • University Hospital Freiburg
  • Homburg, Germany, 66421
    • Saarland University Hospital Department of Trauma, Hand and Reconstructive Surgery
  • Murnau am Staffelsee, Germany, 82418
    • Institut für Biomechanik Berufsgenossenschaftliche Unfallklinik Murnau
  • Tübingen, Germany, 72076
    • Abteilung für Unfall- und Wiederherstellungschirurgie BG Klinik Tübingen
• Netherlands
  • Groningen, Netherlands, 9700
    • University Medical Center Groningen
  • Zwolle, Netherlands, 8000
    • Isala Clinics
• United Kingdom
  • London, United Kingdom, E14DG
    • Barts Health NHS Trust
  • Oxford, United Kingdom, OX39DU
    • Oxford University Hospitals NHS Foundation Trust
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Department of Orthopaedics
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami, Jackson Memorial Hospital Ryder Trauma Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative
  • Texas
    • Austin, Texas, United States, 78712
      • The Value Institute / Department of Surgery and Peri-operative Care. Dell Medical School, University of Texas at Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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)

Description

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 21 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Go Fit Fast: Radiographic measurements, Patient related outcomes (PROs: PROMIS, HOOS, KOOS,), Loading/Activity pattern analysis	Radiographic measurementso Healing (Radiographic Union Score in Tibia Fractures [RUST]/ Radiographic Union Score in Hip Fractures [RUSH]); Patient related outcomesPatient Reported Outcome Measurement Information System (PROMIS): Physical Function (PF) short form Custom AO14 Pain InterferenceHip Disability and Osteoarthritis Outcome Score (HOOS-12) (assessing short- and long-term symptoms and function in hip injuries; the lower score indicates higher symptoms)Knee Injury and Osteoarthritis Outcome Score (KOOS-12) (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)
Recovery Trajectories PROMIS/Linking PROMIS: PROs: PROMIS, HOOS, KOOS, QuickDASH, FAAM	PROs that measure physical limitations: PROMIS PF Short Form Custom AO14 (questions that cover the domain of physical function/mobility from self-care to strenuous activities); PROMIS Upper Extremity (UE) Short Form Custom AO8 (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-12; KOOS-12; Foot and Ankle Ability Measure (FAAM) (21 items of activities of daily living subscale); 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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
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
RUSH score	Radiographic Union Score in Hip Fractures	from the 6-8 weeks until 12 months after the treatment (surgical or not-surgical)
RUST score	Radiographic Union Score for Tibia	from the 6-8 weeks until 12 months after the treatment (surgical or not-surgical)
Numeric Rating Scale (NRS) Pain	An ordinal scale from 0 to 10 with 0 indicating no pain and 10 indicating extreme pain.	from the treatment assessment until 12 months after the treatment (surgical or not-surgical)

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Investigators: Principal Investigator: Marilyn Heng, Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative; Principal Investigator: Prakash Jayakumar, Dell Medical School, University of Texas at Austin; Principal Investigator: Tim Pohlemann, Saarland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: PRO; KOOS; PROMIS; HOOS; FAAM; QuickDASH; PSEQ; PAM
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Arm Injuries; Ankle Injuries; Wrist Injuries; Wrist Fractures; Ankle Fractures; Hip Fractures; Shoulder Fractures; Tibial Fractures; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Care Economics and Organizations; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Surveys and Questionnaires; Health Planning; Health Care Surveys; Health Services Research; Patient Outcome Assessment; Patient Reported Outcome Measures
• Other Study ID Numbers: CPP Patient Outcome

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No