Health Condition 1: V00-Y99- External causes of morbidity
Conditions
Interventions
Intervention1: Tibia Nailing System: Intended for fracture fixation of Tibia bone
Single use device for more than 30 days
Control Intervention1: NA: NA
Sponsors
Kaulmed Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject is willing and able to give informed consent for participation in the study 2. Male or Female, aged 18 years or above, skeletally mature patient. 3. Subject is willing and able to complete required study visits or assessments. 4. Subject diagnosed as per indications.
Exclusion criteria
Exclusion criteria: 1. Subjects with a disease entity or condition that could hindered bone healing and create unacceptable risk of fixation failure or complications such as known active cancer, neuromuscular disorder etc. 2. In case in subject has inadequate tissue coverage of the operative site. (Open fracture, Gustilo type IIIC) 3. Subjects unwilling to sign the Informed Consent document. 4. Subjects who are incarcerated or have pending incarceration. 5. Female participant who is pregnant or planning pregnancy during the course of the study. 6. Fracture that are not amenable to intramedullary tibia nailing technique 7. Morbid obesity (BMI (Kg/m2)) > 35
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of functional performance from baseline to last follow up by recording the Lower extremity functional score (LEFS).Timepoint: Visit - Screening, 1, 2, 3, 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment Quality of Life (QOL) by SF-12Timepoint: Screening, 1, 2, 3, 4;Duration of Hospital stay, Revision rate (Removal of any Component), Re-operation Rate.Timepoint: 12 Months;Evaluation of Safety of Device by record of any adverse event, serious adverse event and complication during follow up, especially the one mentioned in the Instruction of Use. (IFU)Timepoint: Visit - Pre-surgery, Post-surgery, 1, 2, 3, 4;Follow-up of the patient’s recovery by a analysing Visual analogue score (VAS) for pain assessment.Timepoint: Visit - Screening, Pre-surgery, Post-surgery, 1, 2, 3, 4;Mortality.Timepoint: 12 months;Radiologic Evaluation (X-Ray)Timepoint: Screening, Pre-surgery, Post-surgery, 1,2,3,4 | — |
Countries
India
Contacts
Public ContactGaurav Luthra
Kaulmed Private Limited
Outcome results
None listed