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

NCT04113044 | Active Not Recruiting

• 1 other identifier: CPP Patient Outcome
• Study Type: observational
• Target: 1,500
• Locations: 6 countries
• Sites: 15

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.

Conditions

Hip Fractures; Tibial Fractures; Ankle Fractures; Humeral Fracture, Proximal; Distal Radius Fracture

Keywords

PRO; HOOS; KOOS; FAAM; PROMIS; QuickDASH; PSEQ; PAM

Outcome Measures

Primary Outcomes (2)

• 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) 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 \[s\])

  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 Outcomes (11)

• PROMIS Pain Interference

  from the treatment assessment until 12 months after the treatment (surgical or not-surgical)

• PROMIS Depression

  from the treatment assessment until 12 months after the treatment (surgical or not-surgical)

• PROMIS Anxiety

  from the treatment assessment until 12 months after the treatment (surgical or not-surgical)

• PROMIS Ability to Participate in Social Roles and Activities

  from the treatment assessment until 12 months after the treatment (surgical or not-surgical)

• Pain Self-Efficacy Questionnaire (PSEQ)-2

  from the treatment assessment until 12 months after the treatment (surgical or not-surgical)

Interventions

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.

Also known as: Patient Reported Outcomes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AO Innovation Translation Center: lead

Study Sites (15)

Cedars-Sinai Department of Orthopaedics

Los Angeles, California, 90048, United States

Location

University of Miami, Jackson Memorial Hospital Ryder Trauma Center

Miami, Florida, 33136, United States

Location

Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative

Boston, Massachusetts, 02114, United States

Location

The Value Institute / Department of Surgery and Peri-operative Care. Dell Medical School, University of Texas at Austin

Austin, Texas, 78712, United States

Location

Univ.-Klinik für Orthopädie und Traumatologie

Innsbruck, 6020, Austria

Location

Fundación Santa Fe de Bogotá

Bogotá, 110121, Colombia

Location

Centrum für Muskuloskeletale Chirurgie (CMSC) Charite - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

University Hospital Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Saarland University Hospital Department of Trauma, Hand and Reconstructive Surgery

Homburg, 66421, Germany

Location

Institut für Biomechanik Berufsgenossenschaftliche Unfallklinik Murnau

Murnau am Staffelsee, 82418, Germany

Location

Abteilung für Unfall- und Wiederherstellungschirurgie BG Klinik Tübingen

Tübingen, 72076, Germany

Location

University Medical Center Groningen

Groningen, 9700, Netherlands

Location

Isala Clinics

Zwolle, 8000, Netherlands

Location

Barts Health NHS Trust

London, E14DG, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, OX39DU, United Kingdom

Location

MeSH Terms

Conditions

Hip Fractures; Tibial Fractures; Ankle Fractures; Shoulder Fractures; Wrist Fractures

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Ankle Injuries; Shoulder Injuries; Wrist Injuries; Arm Injuries

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: October 2, 2019
• Study Start: February 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); AU (1); GB (2); CO (1); DE (5); NL (2)