Active — Not RecruitingNot Applicable

Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures

United States, Belgium, Germany1,000 participantsStarted 2019-04-04

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 years or older at the time of the injury * Diagnosis of a primary tibial shaft fracture (fracture type 42 according to the AO/OTA Fracture and Dislocation Classification) that will be treated operatively as part of standard of care Exclusion Criteria: * Pathological fracture caused by malignancy * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

What they're measuring

Patient-reported outcome

Timeframe: 6 weeks / 6 months / 12 months / 36 months

Trial details

NCT IDNCT03598530

SponsorAO Clinical Investigation and Publishing Documentation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-17

View on ClinicalTrials.gov More Tibial Fracture trials