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 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT01879150
Eligibility Criteria:
Inclusion Criteria
* Adult males and female subjects, aged 20 to 75 years old, inclusive, at screening visit
* Subject weighing \<100 kg and body mass index (BMI) \<32 kg/m2
* Subjects with confirm diagnosis of HV deformity based on radiography assessment of IMA \> 12 ยบ and less or equal to 20degree.
* Subjects who would need osteotomy of the 1st MT as part of their surgery.
* Able and willing to comply with the requirements of the protocol.
* Able to understand and sign written informed consent to participate in the study
Exclusion criteria
* Contraindication to implantation procedure
* History of: Diabetes mellitus,Claudication vascular disease or known Peripheral Vascular Disease,Rheumatoid disease no palpable pulse (DP or PT),- Gout or any systemic inflammatory arthropathy,Osteoarthritis of first metatarsal,Neurological conditions associated with spasticity,No prior operation at 1st and 2nd Metatarsals
* Osteoporosis
* Secondary metatarsal complications including:Fracture (past or present), Aseptic necrosis or any deformity of 2nd MTH,Subject currently enrolled in or has not yet completed at least 30 days since ending
* Any condition that may jeopardize study participation (e.g. abnormal clinical or laboratory finding), the interpretation of study results or may impede the ability to obtain informed consent (e.g., mental condition)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT01879150
Study Brief:
Protocol Section:
NCT01879150