Health Condition 1: V00-Y99- External causes of morbidity
Conditions
Interventions
Intervention1: Auxein Tibia Plate Implants: Single use surgical implants, Intended for fracture fixation of Tibia bone
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Kaulmed Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject is willing to give informed consent for participation in the study 2. Skeletally mature patient 3. Subject diagnosed as follows: Proximal, shaft & distal fractures of tibia/Articular fractures/ Osteotomies, Malalignment/ Non-Unions/Mal-unions
Exclusion criteria
Exclusion criteria: 1. Specific contraindication related to implant device 2. 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. 3. In case in subject has inadequate tissue coverage of the operative site. (Open fracture, Gustilo type IIIC) 4. Subjects with substance abuse/alcohol issues. 5. Subjects who are incarcerated or have pending incarceration. 6. Female participant who is pregnant or planning pregnancy during the course of the study. 7. Fracture that are not amenable to Tibia Plate osteosynthesis technique 8. Morbid obesity (), (BMI (Kg/m2)) > 35
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean time (Number of days) to achieve bone union and full load bearing capacity. 2. Primary endpoint that is patient reported Lower extremity functional score (LEFS) score will be presented with mean, SD, median min and max with 95% two-sided confidence interval. Change in patient reported Lower extremity functional score (LEFS) score from baseline to 12 months will be analysed using paired t-test at 5% level of significance. 3. Rate of any adverse event and complications during follow-up will be presented with count and percentages. Timepoint: 1 Month 3 Month 6 Month 12 Month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual Analog Scale (VAS) – pain will be presented with mean, median, sd, min and max. Significant change in VAS score from baseline to each visit will be analysed using paired t-test at 0.05 level of significance. 2. Assessment of quality of life using SF-12 data will be presented with mean, median, SD, min and max. 3. Duration of Hospital stay will be presented with mean, median, SD, min and max. 4. Revision rate (Removal of any Component), Re-operation Rate will be presented with counts and percentages. Timepoint: 1 Month 3 Month 6 Month 12 Month | — |
Countries
India
Contacts
Public ContactGaurav Luthra
Kaulmed Private Limited
Outcome results
None listed