None listed
Conditions
Interventions
Medical Device :
The study population consists of patients with long bone fractures (femur, tibia, or humerus) requiring surgical treatment. Enrolled subjects will receive the investigational medical
Sponsors
AIRS Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Adults aged 19 years or older (women must be 75 years of age or younger, and men must be 85 years of age or younger). ? Subjects diagnosed with a long bone fracture (femur, tibia, or humerus) requiring surgical treatment. ? Subjects capable of undergoing medical imaging assessments, including C-arm, X-ray, and CT imaging. ? Subjects able to undergo all examinations and assessments required by the clinical investigation. ? Subjects who understand the clinical investigation plan, have received a detailed explanation of the study methods and objectives, and have voluntarily provided written informed consent to participate in the clinical investigation.
Exclusion criteria
Exclusion criteria: ? Subjects with a history of infection at the fracture site, except those who have fully recovered at the time of screening. ? Subjects with a history of malignancy at the fracture site, except those who have remained recurrence-free for at least 5 years after complete treatment of the malignancy. ? Subjects with neuromuscular disorders or other diseases that may affect the bone healing process. ? Subjects with suspected or documented hypersensitivity to metallic materials, except those who have fully recovered at the time of screening. ? Subjects with fractures located in areas where fixation pin insertion is difficult or not feasible. ? Subjects with a history of continuous corticosteroid use, or those diagnosed with severe osteoporosis as evidenced by a previous medical record or a DXA scan performed within the past 6 months showing a T-score of = -2.5. ? Subjects who are not suitable candidates for surgery due to medical conditions (e.g., pulmonary disease). ? Subjects with a history of psychiatric disorders, unless the investigator determines that participation in the study is appropriate. ? Pregnant or breastfeeding women. ? Subjects who are considered unlikely to comply with study procedures or follow-up requirements. ? Subjects who, in the opinion of the investigator, are otherwise unsuitable for participation in the study for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pin Fixation Strength Assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Fixation Stability Assessment (Clamp, Rod, Pin, Pin-to-Bone Interface);Pin-Site Infection (Dahl’s Grading System);Pin Insertion Time and Total Operative Time;Surgical Usability (Requirement for Additional Fixation or Reduction Procedures);Adverse Event | — |
Countries
Korea, Republic of
Contacts
Public ContactJoonwoo Kim
Kyungpook National University Hospital
Outcome results
None listed