To study performance of humerus nail in bone union in patients with humerus fracture.
- Conditions
- Health Condition 1: S423- Fracture of shaft of humerus
- Registration Number
- CTRI/2024/07/071664
- Lead Sponsor
- Auxein Medical Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients presenting to Orthopaedic emergency/ OPD with Humerus shaft fracture will be included in the study.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method