Health Condition 1: M859- Disorder of bone density and structure, unspecified
Conditions
Interventions
Intervention1: Elbow plate with screws: This is a medical device that will be used for elbow fracture fixation.
Control Intervention1: NA: NA
Sponsors
Auxein Medical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: -Male and female above 18 years to 70 year skeletally mature patients. -Subject with fractures/ malunion of distal humerus (intra/ extraarticular), olecranon/ proximal ulna. -Good joint function before the injury.
Exclusion criteria
Exclusion criteria: -Patients with metabolic bone disease. -Patients having inadequate tissue coverage over the operative site. -Patients that have compromised vascularity that would inhibits adequate blood supply to the fracture or the operative site. -Suspected or documented allergy or intolerance to implant materials. -Patients with symptomatic arthritis. -Severely comminuted fractures in which bone fragments are too small or numerous to adequately fix or maintain a reduced position. -Previously suspected or diagnosed osteoporosis. -Any condition or anatomy that makes treatment with the elbow system infeasible. -Prominent neurological condition that would interfere with physical therapy. -Diagnosed psychiatric disease (E.g Schizophrenia, Major depression, personality disorder) that would interfere with study participation. -Pregnant women or planning pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -To assess the safety and performance of the Elbow Plate System by radiological evaluation for the prospective results of surgical treatment for Elbow Fractures. -Evaluation of functional performance from baseline to last follow up by recording the DASH Score.Timepoint: 1,3,6 and 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| -Pain evaluation through Visual Analogue Scale (VAS). -Adverse Event assessment.Timepoint: 12 Months | — |
Countries
India
Contacts
Public ContactMr Gaurav Luthra
Auxein Medical Pvt Ltd
Outcome results
None listed