A Post Market Clinical follow ?up study of Humerus and Ulna System (Proximal Humerus Plate) intended for fracture fixation.
- Conditions
- Health Condition 1: V00-Y99- External causes of morbidity
- Registration Number
- CTRI/2022/08/044616
- Lead Sponsor
- Auxein Medical Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
1. Participant has confirmed diagnosis as per the indications.
2. Subject is willing and able to give informed consent for participation in the study.
3. Male or Female, aged 18 years or above, skeletally mature patient.
4.Subject is willing and able to complete required study visits or assessments.
1. Infection, local to the operative site.
2. Signs of local inflammation.
3. Pregnancy.
4. Severely comminuted fractures in which bone fragments are too small or numerous to adequately fix or maintain a reduced position
5. Patient susceptibility to allergic reaction to the components of the alloy, the implant is manufactured from.
6. Mental illness or schizophrenia, which may cause patients to ignore the limitations and precautions of the implanted material, leading to implants fracture and complication.
7. Alcohol or drug addict
8. Severe osteopenia and/or osteoporosis, or in the presence of marked or rapid bone absorption, metabolic bone disease, cancer, or any other tumor-like condition of the bone which may compromise fixation. Osteoporosis is a relative contraindication since this condition may limit the degree of
obtainable correction, the amount of mechanical fixation.
9. Symptomatic Arthritis
10. Any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition.
11. Any time implant utilization would interfere with anatomical structures or expected physiological performance.
12. Any patient unwilling to cooperate with the post-operative instructions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the prospective performance results of surgical treatment of patients treated with PHEELOS- 3.5 mm wise lock proximal humerus plate by: <br/ ><br> ? Pain, range of motion and power evaluation through average constant score.Timepoint: Time Frame- 1, 3, 6, 12 months postoperatively
- Secondary Outcome Measures
Name Time Method To analyse the safety associated with wise lock <br/ ><br>proximal humerus along with the following. <br/ ><br> ? Quality of fusion through radiological evaluation. <br/ ><br> ? Adverse Event, complications.Timepoint: Time Frame- 1, 3, 6, 12 months postoperatively