CTRI/2022/08/044616
Other
未知
A Non ?Randomized, Prospective, Post Market Clinical follow ?up study to evaluate the Safety and Performance of Humerus and Ulna System intended for fracture fixation. - PHEELOS
Auxein Medical Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: V00-Y99- External causes of morbidity
- Sponsor
- Auxein Medical Pvt Ltd
- Status
- Other
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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