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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:
III) Linking PROMIS®: Linking of PROMIS Measures to Legacy Measures in an Orthopaedic Patient Population
Objectives:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics. | Other | All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Go Fit Fast: Radiographic measurements, Patient related outcomes (PROs: PROMIS, HOOS, KOOS,), Loading/Activity pattern analysis |
| 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:
| from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical) |
| 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) |
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Inclusion Criteria:
Age 18 years and older
Diagnosis of one of, isolated injury
English, German, or Spanish speaking
Informed consent obtained, i.e.:
Exclusion Criteria:
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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)
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Department of Orthopaedics | Los Angeles | California | 90048 | United States | ||
| University of Miami, Jackson Memorial Hospital Ryder Trauma Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42091143 | Derived | AOBERT Consortium. Optimising the utility of patient-reported outcome measurements during recovery after orthopaedic extremity fractures: protocol for a multicentre prospective cohort study. BMJ Open. 2026 May 6;16(5):e113927. doi: 10.1136/bmjopen-2025-113927. |
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| 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) |
| Miami |
| Florida |
| 33136 |
| United States |
| Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative | Boston | Massachusetts | 02114 | United States |
| The Value Institute / Department of Surgery and Peri-operative Care. Dell Medical School, University of Texas at Austin | Austin | Texas | 78712 | United States |
| Univ.-Klinik für Orthopädie und Traumatologie | Innsbruck | 6020 | Austria |
| Fundación Santa Fe de Bogotá | Bogotá | 110121 | Colombia |
| Centrum für Muskuloskeletale Chirurgie (CMSC) Charite - Universitätsmedizin Berlin | Berlin | 13353 | Germany |
| University Hospital Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Saarland University Hospital Department of Trauma, Hand and Reconstructive Surgery | Homburg | 66421 | Germany |
| Institut für Biomechanik Berufsgenossenschaftliche Unfallklinik Murnau | Murnau am Staffelsee | 82418 | Germany |
| Abteilung für Unfall- und Wiederherstellungschirurgie BG Klinik Tübingen | Tübingen | 72076 | Germany |
| University Medical Center Groningen | Groningen | 9700 | Netherlands |
| Isala Clinics | Zwolle | 8000 | Netherlands |
| Barts Health NHS Trust | London | E14DG | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Oxford | OX39DU | United Kingdom |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D013978 | Tibial Fractures |
| D064386 | Ankle Fractures |
| D012784 | Shoulder Fractures |
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D016512 | Ankle Injuries |
| D000070599 | Shoulder Injuries |
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
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| ID | Term |
|---|---|
| D000071066 | Patient Reported Outcome Measures |
| ID | Term |
|---|---|
| D019538 | Health Care Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D063868 | Patient Outcome Assessment |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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