Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures (NCT03598530)
Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures (FROST)
🩺 Plain-English Summary (8th-Grade Level)
Approximately 1000 patients presenting with tibial shaft fractures (AO type 42) will be enrolled prospectively in this registry. All patients are treated and followed at 6 weeks, 6 months and 1 year postoperative always following the local standard of care (routine) visit schedule up to 36 months if required. Data collection includes patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (i.e. complications) and their corresponding treatment
Who can join: Review the eligibility criteria below.
Location: NYU Langone and affiliated Hospitals — New York, New York
Age range: 18 Years
🧪 Interventions in This Study
- Surgery (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- NYU Langone and affiliated Hospitals — New York, New York
- NYU Langone Jamaica Hospital Medical Center — New York, New York
- Vanderbilt University Medical Center — Nashville, Tennessee
- Department of Trauma Surgery, UZ Leuven — Leuven,
- University Medical Center Mainz — Mainz,
- Medical Faculty LMU Munich — Munich,
- University Hospital Münster — Münster,
- Queen Mary Hospital — Hong Kong,
- Sengkang General Hospital — Singapore,
- Tygerberg Hospital — Cape Town,
- Korea University Guro Hospital — Seoul,
- University Hospital Basel — Basel,
- University Hospital Zurich — Zurich,
- University Hospitals Coventry & Warwickshire NHS Trust — Coventry,
- Leeds General Infirmary University Hospital — Leeds,
💰 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.
More studies in Tibial Fracture
- Blood Flow Restriction Therapy to Optimize Muscle Size and Strength in Recovery From Lower Limb Fractures — Vancouver, British Columbia
- Tibial IMN Vs. Tibial Micromotion IMN — Chicago, Illinois
Explore by condition: All Tibial Fracture clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.