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 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT00875992
Eligibility Criteria:
Inclusion Criteria:
* The patient is ≥ 18 years old
* The patient suffers from an acute distal third tibial fracture classified as:
AO 42 A1-A3, AO 42 B1-B3, AO 42 C1-C3, AO 43 A1-A3
* The fracture is fixed with an Expert Tibia Nail (ETN)
* The patient was able to walk without walking aid prior to the accident
* The patient is able to understand and read local language at elementary level
* The patient is willing and able to give written informed consent to participate in the study according to the CIP
Exclusion Criteria:
* The patient is legally incompetent
* Preexistent malunion or nonunion of the fracture under investigation
* Osteotomies
* The patient suffers from additional fractures of the lower extremities (Exception: ipsilateral fibular fracture)
* The patient suffers from a pathologic fracture
* The patient suffers from active malignancy
* The patient is pregnant, breast feeding or planning to get pregnant during the study period
* The patient suffers from a life-threatening condition
* The patient is affected by drug or alcohol abuse
* The patient has participated in any device related clinical trial affecting the lower extremities within the previous month
* The patient has participated in any drug related clinical trial affecting bone healing within the previous month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00875992
Study Brief:
Protocol Section:
NCT00875992