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:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT01358292
Eligibility Criteria:
Inclusion Criteria:
* Patient has sustained a closed (Tscherne Classification) or open tibial fracture (Gustillo-Anderson Classification) that is amendable for operative fixation with an intramedullary nail.
* Patient has an isolated tibia and fibula fracture
* Skeletally mature
* Patients aged between/including 18 to 70 years
* Patient has given formal consent to be involved in the trial and has completed the study consent form
* Patient is likely to comply with study follow-up requirements
Exclusion Criteria:
* Pathologic fractures
* Other fractures involving the same lower extremity
* Soft tissue injuries/problems that would prevent the surgeon from using both of the surgical techniques to insert an intramedullary nail
* Patient having pre-existing knee joint disease causing anterior knee pain
* Patient likely to have problems with follow-up
* Patient unwilling to give informed consent to be included in the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01358292
Study Brief:
Protocol Section:
NCT01358292