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 @ 2:21 PM
Ignite Modification Date:
2025-12-24 @ 2:21 PM
NCT ID:
NCT03100695
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-65, skeletally mature adults.
* Acute unilateral closed tibia diaphyseal fractures as the primary injury.
* Definitive fracture fixation with reamed intramedullary nailing (statically locked) or fine wire ring external fixator to be performed within 14 days from the date of injury.
* Willing and able (in the opinion of the study team) to provide informed consent and participate in all study activities.
Exclusion Criteria:
* Open/compound tibial fracture.
* Fracture Type 42-C2 according to Muller AO classification.
* Multi-segmental nature of this fracture (more than one fracture site within tibia for intervention.)
* Polytrauma (defined as injury severity score of 17 or more.)
* Prior or concomitant illnesses that may affect healing.
* Exposure to drugs that can affect the bone metabolic state within the past three months.
* Receiving chemotherapy, radiation treatment or immunosuppression drugs.
* Currently enrolled in any other study which may impact on the results of the present study.
* If female: pregnancy, breast-feeding, not currently using and not willing to use an effective form of contraception for 12 months post-surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03100695
Study Brief:
Protocol Section:
NCT03100695