Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS® (NCT04113044)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (10 items).
Location: Cedars-Sinai Department of Orthopaedics — Los Angeles, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (15 Sites)
- Cedars-Sinai Department of Orthopaedics — Los Angeles, California
- University of Miami, Jackson Memorial Hospital Ryder Trauma Center — Miami, Florida
- Massachusetts General Hospital Harvard Orthopaedic Trauma Initiative — Boston, Massachusetts
- The Value Institute / Department of Surgery and Peri-operative Care. Dell Medical School, University of Texas at Austin — Austin, Texas
- Univ.-Klinik für Orthopädie und Traumatologie — Innsbruck,
- Fundación Santa Fe de Bogotá — Bogotá,
- Centrum für Muskuloskeletale Chirurgie (CMSC) Charite - Universitätsmedizin Berlin — Berlin,
- University Hospital Freiburg — Freiburg im Breisgau,
- Saarland University Hospital Department of Trauma, Hand and Reconstructive Surgery — Homburg,
- Institut für Biomechanik Berufsgenossenschaftliche Unfallklinik Murnau — Murnau am Staffelsee,
- Abteilung für Unfall- und Wiederherstellungschirurgie BG Klinik Tübingen — Tübingen,
- University Medical Center Groningen — Groningen,
- Isala Clinics — Zwolle,
- Barts Health NHS Trust — London,
- Oxford University Hospitals NHS Foundation Trust — Oxford,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.