Elbow bone injury
- Conditions
- Health Condition 1: M859- Disorder of bone density and structure, unspecified
- Registration Number
- CTRI/2024/01/061499
- Lead Sponsor
- Auxein Medical Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method