Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: NIL: NIL
Sponsors
CHETAN MEDITECH PVT. LTD.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Any individual with symptomatic hand & wrist injuries who has failed non-operative and/or require repair by surgery as per the Principal Investigator s review. 2. Male or female subject above 18 years of age at time of surgery. 3. Subjects 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 Hand and wrist 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 and osteoporosis. 8. Patient conditions include blood supply limitation and previous infections. 9. Active ulcers/ venous ulcers/diabetic infections/ 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 percent), and/ or any other severe metabolic disorders that makes the Subject unfit for surgical procedure. 13. Subjects with uncontrolled hypertension (DBP greater or equal to 100 mm Hg and SBP greater or 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. Any other ailment/disorder that is not suitable for the subject at the discretion of the investigator. 17. Subject failed to give written consent prior to enrolment. 18. Morbid obesity. (defined as per WHO guidelines)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Success Rate (in percentage)Timepoint: 06 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Success RateTimepoint: 09 & 12 Months;Visual Analogue Score (VAS)Timepoint: Baseline, 06, 09 & 12 Months;Quick - Disabilities of the arm, shoulder and hand (QDASH)Timepoint: Baseline, 06, 09 & 12 Months;Range of Motion (ROM- wrist and fingers)Timepoint: Baseline, 06, 09 & 12 Months;Pinch strengthTimepoint: Baseline, 06, 09 & 12 Months;Grip strengthTimepoint: Baseline, 06, 09 & 12 Months;Mayo Wrist ScoreTimepoint: Baseline, 06, 09 & 12 Months | — |
Countries
India
Contacts
Public ContactShweta Patel
Chetan Meditech Pvt. Ltd.
Outcome results
None listed