Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
Conditions
Interventions
Intervention1: NIL: NIL
Intervention2: Nil: Nil
Sponsors
CHETAN MEDITECH PVT. LTD.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Any individual with symptomatic Foot & Ankle injuries who has failed non-operative treatment and/or require repair by surgery as per the Principal Investigatorâ??s review. 2. Male or female subject above 18 years of age at time of surgery. 3. Subject willing to comply with all the study follow-up procedures and requirements. 4. Subjects willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Known Hypersensitivity to the implant material. 2. Patients requiring artificial ligaments to attach in Foot & Ankle injuries. 3. Patients with 2 or more failed implantation or surgical procedures in past. 4. Acute or chronic local or systemic infection. 5. Patients with insufficient or immature bone. 6. Patients with cognitive impairment or neurologic conditions who are unwilling or incapable of following postoperative care instructions. 7. Pathological conditions of bone & soft tissue, such as osteopenia or osteoporosis. 8. Patient conditions include blood supply limitation and previous infections. 9. Active foot ulcers or venous ulcers or diabetic foot infections or chronic venous disease. 10. Comminated bone surface which hinder the fixation capacity of implant. 11. Pregnant and lactating women. 12. Subjects with uncontrolled diabetes mellitus (Hba1c above 8.5%), and or any other severe metabolic disorders that makes the subject unfit for surgical procedure. 13. Subjects with uncontrolled hypertension (DBP more than equal to 100 mm Hg and SBP more than equal to 180 mm despite receiving medication at time of enrolment. 14. Subjects with moderate to severe liver impairment and impaired renal function. 15. Subjects with history of uncontrolled epileptic seizures. 16. Subject failed to give written consent prior to enrolment. 17. Morbid obesity. (Defined as per WHO guidelines) 18. Any other ailment or disorder that is not suitable for the subject at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Success Rate Clinical success is defined as foot and ankle repairs without signs of device failure and/or need of re-intervention as assessed by the surgeon.Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Success RateTimepoint: 12 months;-Visual Analogue score (VAS) -Foot and Ankle Outcome Score (FAOS) -Foot and Ankle Disability Index (FADI) -Range of Motion (ROM)Timepoint: Baseline & 2, 6, 12 months;-All adverse events and serious adverse event occurring during surgery or post-surgery -Type and frequency of all reported AE/SAEs/ADE/SADE or any Device Deficiency/Device malfunctionTimepoint: Until study termination or study completion. | — |
Countries
India
Contacts
Public ContactShweta Patel
Chetan Meditech Pvt. Ltd.
Outcome results
None listed