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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT02245893
Eligibility Criteria:
Inclusion Criteria:
1. The subject is 18 years old or greater with a pre-operative diagnosis of a Weber C ankle fracture (supination-external rotation, pronation-external rotation, pronation-abduction patterns).
2. The subject demonstrates lateral subluxation of the talus on x-ray or stress views (unstability).
3. The lateral malleolus fracture if present begins at least 1.0 cm proximal to the syndesmosis.
4. The subject has no history of previous ankle injury.
5. The subject does not have an ipsilateral lower extremity injury that would impede results.
6. The subject has no neuromuscular or neurosensory deficiency that would limit the ability to assess the operative procedure.
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Exclusion Criteria:
1. The subject has a lateral malleolus fracture that begins less than 1.0 cm proximal to the syndesmosis.
2. The subject has an open ankle fracture with a lateral wound. -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02245893
Study Brief:
Protocol Section:
NCT02245893