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 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT05017961
Eligibility Criteria:
Inclusion Criteria:
* Closed displaced intra-articular fracture without any evidence of nerve or blood vessel injury, the fractures belonged to Sanders type III according to Sanders classification and amenable to open reduction internal fixation
* Life expectancy of at least 1 year
* Patient is willing to provide informed consent, is geographically stable and able to comply with the required follow up visits, testing schedule and medication regimen
* Adequate soft tissue coverage at the fracture site through primary closure.
* Unilateral or bilateral calcaneal fractures.
Exclusion Criteria:
* Pregnant or breastfeeding women or planning on becoming pregnant during the investigational period
* Patient is currently participating in an investigational drug or other device study or previously enrolled in this study.
* Uncontrolled diabetes mellitus (hemoglobin A1c levels \> 10%)
* A current endocrine or metabolic disorder known to affect osteogenesis
* Currently has untreated malignant neoplasm(s), or is currently undergoing radiation therapy or chemotherapy.
* Inadequate neurovascular status in the involved limb that may jeopardize healing.
* Patients who have a preexisting calcaneus deformity that cannot accommodate a reduction or a previous history of osteomyelitis in the index limb.
* Other ipsilateral lower extremity fracture(s) if, in the opinion of the investigator, the treatment and/or rehabilitation of such fracture(s) will substantially interfere with the treatment, rehabilitation or other requirements outlined in this protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05017961
Study Brief:
Protocol Section:
NCT05017961