Health Condition 1: S424- Fracture of lower end of humerus
Conditions
Interventions
Intervention1: Distal humerus plate system: Intervention is intended to provide fixation of distal humerus fracture. The enrolled patients will be followed up at various time points till one year of s
Sponsors
Auxein Medical Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients presenting to Orthopaedic emergency/OPD with distal humerus fractures/ intercondylar humerus fracture.
Exclusion criteria
Exclusion criteria: 1. Infection, local or systemic, acute or chronic inflammation at the operative site. 2. Patient with known history of metal allergy. 3. Mental illness or schizophrenic, which may cause patients to ignore the limitations and precautions of the implanted material leading to implants fracture and complication. 4. Patients having inadequate tissue coverage over the operative site. 5. Presence of marked or rapid bone absorption, metabolic bone disease, cancer, or any other tumor ?like condition of the bone which may compromise fixation. 6. Female participant who is pregnant or planning pregnancy during the course of the study. 7. Chronic alcoholics, and smokers. 8. Any condition or anatomy that makes treatment with the distal humerus plate system infeasible. 9. Patients who are incarcerated or have pending incarceration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluation of function outcome scores (MEPS and Quick DASH). 2. Improvement in pain score (VAS).Timepoint: Three time points; 3, 6, and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Radiological evaluation by X-ray radiographs to assess the mean time taken to achieve bone union. 2. Evaluation of any complications/adverse events associated with implants.Timepoint: Three time points; 3, 6, and 12 months. | — |
Countries
India
Contacts
Public ContactMr Gaurav Luthra
Auxein Medical Private Limited
Outcome results
None listed