Health Condition 1: S423- Fracture of shaft of humerus
Conditions
Interventions
Intervention1: Humerus nailing: Total duration of intervention is one year
Control Intervention1: There is no comparator agent in the study.: This is a single arm study.
Sponsors
Auxein Medical Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patients presenting to Orthopaedic emergency/ OPD with Humerus shaft fracture will be included in the study.
Exclusion criteria
Exclusion criteria: 1. Infection, local or Systemic Acute or Chronic Inflammation to the operative site. 2. Subjects with a disease entity or condition that could hindered bone healing and create unacceptable risk of fixation failure complications such as known active cancer, neuromuscular disorder etc. 3. In case subject has inadequate tissue coverage of the operative site. 4. Subjects with Symptomatic Arthritis. 5. Subjects with Suspected or documented metal allergy or intolerance. 6. Subjects with substance abuse/alcohol issues. 7. Subjects who are incarcerated or have pending incarceration. 8. Female participant who is pregnant or planning pregnancy during the course of the study. 9. Fracture that are not amenable to humerus nailing technique. 10. Any patient unwilling to cooperate with the post-operative instructions. 11. Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site. 12. Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation of the devices. 13. Implant utilization that would interfere with anatomical structures or physiological performance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Radiological Evaluation by X-ray radiographs to calculate mean time to achieve bone fusion and deformity correction or stabilization. 2.Quality of movement in arm and shoulder by calculating DASH score. Timepoint: Follwo up at 6 week, 3 month, 6 month, and 12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Analyzing Visual analogue score (VAS) for pain assessment. 2. Any adverse event or serious adverse event during follow up, especially the one mentioned in the Product Description. Timepoint: 6 weeks, 3, 6, and 12 months | — |
Countries
India
Contacts
Public ContactDr Mohd Aslam
Auxein Medical Private Limited
Outcome results
None listed