Hip FracturesNCT04113044
Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS®
An observational study of Hip Fractures and Tibial Fractures, run by AO Innovation Translation Center at 15 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Tibial Fractures, Ankle Fractures
- What is being tested?
- All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics.
- How many people
- 1,500 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 1 Feb 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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)
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Germany5 sites
Centrum für Muskuloskeletale Chirurgie (CMSC) Charite - Universitätsmedizin Berlin
Berlin, 13353
University Hospital Freiburg
Freiburg im Breisgau, 79106
Saarland University Hospital Department of Trauma, Hand and Reconstructive Surgery
Homburg, 66421
Institut für Biomechanik Berufsgenossenschaftliche Unfallklinik Murnau
Murnau am Staffelsee, 82418
Abteilung für Unfall- und Wiederherstellungschirurgie BG Klinik Tübingen
Tübingen, 72076
United States4 sites
The Value Institute / Department of Surgery and Peri-operative Care. Dell Medical School, University of Texas at Austin
Austin, Texas, 78712
Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative
Boston, Massachusetts, 02114
Cedars-Sinai Department of Orthopaedics
Los Angeles, California, 90048
University of Miami, Jackson Memorial Hospital Ryder Trauma Center
Miami, Florida, 33136
Netherlands2 sites
University Medical Center Groningen
Groningen, 9700
Isala Clinics
Zwolle, 8000
United Kingdom2 sites
Barts Health NHS Trust
London, E14DG
Oxford University Hospitals NHS Foundation Trust
Oxford, OX39DU
About this study
Official title: 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.
Read the detailed description
More in detail this observational study includes the following sub-projects:
- 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:
- To identify the factors predictive of longer term magnitude of limitations after extremity fractures (using PROMs)
- To assess minimal clinically important difference (MCID) and substantial clinical benefit (SCB) in PROM scores
- 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:
- 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.
- Apply the methods of item-response theory (IRT) linking to establish a common standardized metric.
- Develop equations for conversion of a PROMIS PF/UE and PAIN INT score to each of the specified legacy measures and vice-versa.
- Conditions
- Hip Fractures, Tibial Fractures, Ankle Fractures, Humeral Fracture, Proximal, Distal Radius Fracture
- Being tested
- All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics.
- Keywords
- PRO, HOOS, KOOS, FAAM, PROMIS, QuickDASH, PSEQ, PAM
- Medical subject headings
- Hip Fractures, Tibial Fractures, Ankle Fractures, Shoulder Fractures, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics.Other
Also called Patient Reported Outcomes
All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics.
What is being measured
The primary outcome is the main question the study is designed to answer.
Go Fit Fast: Radiographic measurements, Patient related outcomes (PROs: PROMIS, HOOS, KOOS,), Loading/Activity pattern analysis
- Radiographic measurements
- 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) short form Custom AO14 Pain Interference
- Hip 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])
Measured: 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)
Measured: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Pre-treatment
RUSH score
Radiographic Union Score in Hip Fractures
Measured: from the 6-8 weeks until 12 months after the treatment (surgical or not-surgical)
RUST score
Radiographic Union Score for Tibia
Measured: 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.
Measured: from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Feb 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marilyn Heng, Principal investigator, Massachusetts General Hospital Harvard Orthopaedic Trauma InitiativePrakash Jayakumar, Principal investigator, Dell Medical School, University of Texas at AustinTim Pohlemann, Principal investigator, Saarland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113044
- Sponsor's protocol ID
- CPP Patient Outcome
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2019
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42091143
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Priority Program (CPP) Clinical Outcome Measurement of Fracture Treatment:
- ClinicalTrials.gov ID
- NCT04113044
- Acronym / sponsor ID
- CPP Patient Outcome
- Conditions
- Hip Fractures, Tibial Fractures, Ankle Fractures, Humeral Fracture, Proximal, Distal Radius Fracture
- Keywords
- PRO, HOOS, KOOS, FAAM, PROMIS, QuickDASH, PSEQ, PAM
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- To identify the factors predictive of longer term magnitude of limitations after extremity fractures (using PROMs)
- To assess minimal clinically important difference (MCID) and substantial clinical benefit (SCB) in PROM scores
- 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:
- 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.
- Apply the methods of item-response theory (IRT) linking to establish a common standardized metric.
- Develop equations for conversion of a PROMIS PF/UE and PAIN INT score to each of the specified legacy measures and vice-versa.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (12 listed)
- Age 18 years and older
- Diagnosis of one of, isolated injury
- English, German, or Spanish speaking
- Informed consent obtained, i.e.:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics.Also: Patient Reported OutcomesAll treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics. | Other | – |
Primary outcome
Go Fit Fast: Radiographic measurements, Patient related outcomes (PROs: PROMIS, HOOS, KOOS,), Loading/Activity pattern analysis
Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
* 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) short form Custom AO14 Pain Interference * Hip 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])
Recovery Trajectories PROMIS/Linking PROMIS: PROs: PROMIS, HOOS, KOOS, QuickDASH, FAAM
Time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
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)
11 secondary outcomes
PROMIS Pain Interference
Time frame: from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
PROMIS Depression
Time frame: from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
PROMIS Anxiety
Time frame: from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
PROMIS Ability to Participate in Social Roles and Activities
Time frame: from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
Pain Self-Efficacy Questionnaire (PSEQ)-2
Time frame: from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
Patient Activation Measure (PAM)-10
Time frame: from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
Cognitive assessment
Time frame: Pre-treatment
Mobility Scores
Time frame: Pre-treatment
RUSH score
Time frame: from the 6-8 weeks until 12 months after the treatment (surgical or not-surgical)
RUST score
Time frame: from the 6-8 weeks until 12 months after the treatment (surgical or not-surgical)
Numeric Rating Scale (NRS) Pain
Time frame: from the treatment assessment until 12 months after the treatment (surgical or not-surgical)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Derived from this study: PubMed 42091143AOBERT 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilyn Heng principal investigator
Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative
Prakash Jayakumar principal investigator
Dell Medical School, University of Texas at Austin
Tim Pohlemann principal investigator
Saarland University Hospital
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Tibial Fractures, run by AO Innovation Translation Center at 15 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, United States, Netherlands, United Kingdom, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Go Fit Fast: Radiographic measurements, Patient related outcomes (PROs: PROMIS, HOOS, KOOS,), Loading/Activity pattern analysis (time frame: from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04113044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.