Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT01341418
Eligibility Criteria:
Inclusion Criteria:
* Tibial shaft fractures amenable and indicated for repair with intramedullary nails, with or without the use of reaming
* Acute tibial fractures within 4 weeks of injury
* Closed or open tibial fractures after appropriate irrigation and debridement
* Fractures must be within metaphyseal/diaphyseal junctures defined as middle 3/5 of tibia
* Skeletally mature patient
* Age 18 and above.
Exclusion Criteria:
* Tibial shaft fractures that require articular reconstruction with plates
* Any tibial fracture extending \> 1 cm into the proximal or distal 1/5 of tibia
* Tibial plateau fractures
* Pilon fractures
* Periprosthetic fractures
* Non-unions
* Prior knee surgery
* History of gout or rheumatoid or osteoarthritis
* Concomitant injury to same limb (including any traumatic injury to ipsilateral knee, femur or foot, and knee dislocation)
* Spinal injury
* Prisoner or high likelihood of incarceration
* Not likely to follow-up in the estimation of surgeon
* Pregnant females
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01341418
Study Brief:
Protocol Section:
NCT01341418