Observing recovery patterns in patients with extremity fractures
Clinical Priority Program (CPP) Clinical Outcome Measurement of Fracture Treatment:
This study is looking at how different patients recover from various arm and leg fractures over a year to see what treatments work best and improve their outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AO Innovation Translation Center Academic / other |
| Locations | 15 sites (Los Angeles, California and 14 other locations) |
| Trial ID | NCT04113044 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect prospective data from approximately 3,500 patients with various extremity fractures, including hip, tibial, ankle, humeral, and radius fractures. Patients will be followed for up to one year post-treatment, with data collected on underlying conditions, treatment details, patient-reported outcomes (PROs), and any complications. The study includes sub-projects focusing on individualized treatment based on sensor data, defining recovery trajectories using PROMIS measures, and linking PROMIS scores to traditional orthopedic measures. The goal is to optimize decision-making and improve patient outcomes following extremity fractures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with isolated extremity fractures who can communicate in English, German, or Spanish.
Not a fit: Patients with multiple fractures, pathological fractures due to cancer, or those with recent substance abuse issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance recovery strategies and improve outcomes for patients with extremity fractures.
How similar studies have performed: Other studies have shown promise in using patient-reported outcomes and sensor data to improve recovery trajectories, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Los Angeles, California and 14 other locations
- Cedars-Sinai Department of Orthopaedics — Los Angeles, California, United States (Recruiting)
- University of Miami, Jackson Memorial Hospital Ryder Trauma Center — Miami, Florida, United States (Recruiting)
- Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative — Boston, Massachusetts, United States (Recruiting)
- The Value Institute / Department of Surgery and Peri-operative Care. Dell Medical School, University of Texas at Austin — Austin, Texas, United States (Recruiting)
- Univ.-Klinik für Orthopädie und Traumatologie — Innsbruck, Austria (Recruiting)
- Fundación Santa Fe de Bogotá — Bogotá, Colombia (Recruiting)
- Centrum für Muskuloskeletale Chirurgie (CMSC) Charite - Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
- University Hospital Freiburg — Freiburg, Germany (Not_yet_recruiting)
- Saarland University Hospital Department of Trauma, Hand and Reconstructive Surgery — Homburg, Germany (Recruiting)
- Institut für Biomechanik Berufsgenossenschaftliche Unfallklinik Murnau — Murnau Am Staffelsee, Germany (Recruiting)
- Abteilung für Unfall- und Wiederherstellungschirurgie BG Klinik Tübingen — Tuebingen, Germany (Not_yet_recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
- Isala Clinics — Zwolle, Netherlands (Recruiting)
- Barts Health NHS Trust — London, United Kingdom (Recruiting)
- Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom (Active_not_recruiting)
Study contacts
- Principal investigator: Marilyn Heng — Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative
- Study coordinator: Aleksandra Hodor, PhD
- Email: aleksandra.hodor@aofoundation.org
- Phone: +41 44 200 24 81
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.