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 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT02953067
Eligibility Criteria:
Inclusion Criteria:
Stratum 1:
* Nondislocated fractures affecting tarsometatarsal (TMT) joints II and III
* Dislocation \<5mm between medial cuneiforme and base of II metatarsal (MT)
* No fractures affecting TMT joints IV and V
Stratum 2:
* Affected joints TMT II- III + any other TMT
* Any dislocation \>2mm (fracture or TMT joint)
* Dislocation \>5mm between medial cuneiforme and base of II MT
Exclusion Criteria:
* Open fractures
* Extra-articular metatarsal (MT) fractures
* Extremely comminuted fractures with bone loss, and slight chance of gaining proper reduction with screws
* Patients with multiple fractures
* Patients with weak co-operation (dementia, alcohol use, etc.)
* Patients with significant neuropathy or some other neurological condition, diabetes and rheumatoid arthritis
* Patients with severe circulatory disorder of the lower limb
* Injuries over 14 days
* Patients with previous foot injury or surgery
* Pregnancy
* Patients who refuse to participate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02953067
Study Brief:
Protocol Section:
NCT02953067