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 @ 5:59 PM
Ignite Modification Date:
2025-12-24 @ 5:59 PM
NCT ID:
NCT02198768
Eligibility Criteria:
Inclusion Criteria:
* Patients who sustain an isolated bi-malleolar or trimalleolar ankle fracture or an ankle fracture-dislocation requiring open reduction internal fixation
* Patients ages 18 and over
* The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study
* Open and closed fractures (excluding Gustilo grade 3)
* English must be patient's primary language
Exclusion Criteria:
* Previous injury or significant osteoarthritis to the affected ankle
* Current ipsilateral or contralateral lower extremity injury with the exception of a contralateral ankle fracture or fracture-dislocation
* Retained hardware from a previous injury at or around the tibia-talar joint of the affected extremity
* Patients under the age of 18
* History of inflammatory arthropathy
* Traumatic Brain Injury or Spinal Cord Injury preventing weightbearing on the lower extremities
* The subject has another concurrent physical or mental condition that is likely to affect compliance with the study requirements
* Patients with Gustilo grade 3B and 3C open fractures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02198768
Study Brief:
Protocol Section:
NCT02198768