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NCT03598530 · ClinicalTrials.gov registry record
Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures
A clinical trial of Tibial Fracture and Fracture of the Tibia Type AO/OTA 42, sponsored by AO Clinical Investigation and Publishing Documentation.
- Active
- Registry status
- 1,000
- Enrollment target
- 15
- Study locations
NCT03598530: Active study of Tibial Fracture and Fracture of the Tibia Type AO/OTA 42, sponsored by AO Clinical Investigation and Publishing Documentation.
NCT03598530 is a study of Tibial Fracture and Fracture of the Tibia Type AO/OTA 42 that is active but no longer recruiting, run by AO Clinical Investigation and Publishing Documentation. The registered enrollment target is 1,000 participants. The trial reports 15 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03598530, a study of Tibial Fracture and Fracture of the Tibia Type AO/OTA 42, is active but no longer recruiting, sponsored by AO Clinical Investigation and Publishing Documentation.
- ACTIVE NOT RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 15
- Study locations
Study Summary
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
Primary Outcome
Change in PROMIS Pain interference (v1.0 - Pain Interference 8a) over the the follow-up period Change in PROMIS: Physical function (mobility) (v2.0 - Physical Function 10b) over the the follow-up period
Conditions Studied
Interventions
- PROCEDURE Surgery
Study Locations (15)
Other
- 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
New York
- NYU Langone and affiliated Hospitals - New York
- NYU Langone Jamaica Hospital Medical Center - New York
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2019-04-04 |
| Est. Completion | 2025-12-31 |
What the registry record for NCT03598530 still lists
NCT03598530 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 2 conditions, with Tibial Fracture appearing as the primary indexed condition, and to 1 intervention - of which Surgery is the first listed.
NCT03598530 lists 15 locations in 3 states (Other, New York, Tennessee).
Frequently Asked Questions
What is clinical trial NCT03598530 about?
NCT03598530 is a clinical study titled "Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures". 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...
What is the current status of trial NCT03598530?
This trial is currently active not recruiting. The enrollment target is 1,000 participants. The study started on 2019-04-04. Estimated completion is 2025-12-31.
What conditions does trial NCT03598530 study?
This clinical trial studies the following conditions: Tibial Fracture, Fracture of the Tibia Type AO/OTA 42.
What interventions are being tested in trial NCT03598530?
The interventions under investigation include: Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT03598530?
This trial is sponsored by AO Clinical Investigation and Publishing Documentation, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03598530 being conducted?
This trial has 15 study locations across New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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