A Prospective Multicenter Cohort Study About Internal Fixation Using PFUN Versus PFNA for Femoral… (NCT06277622) | Clinical Trial Compass
UnknownNot Applicable
A Prospective Multicenter Cohort Study About Internal Fixation Using PFUN Versus PFNA for Femoral Intertrochanteric Fracture
China130 participantsStarted 2024-01-01
Plain-language summary
This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral intertrochanteric fracture (AO classification 31-A) using Proximal Femoral Universal Nail (PFUN) versus Proximal Femoral Nail Antirotation (PFNA) at 21-month follow up. The patients are divided into the PFUN group and the PFNA group according to the internal fixation they choose. The internal fixation failure rate (IFFR) and differences in fracture prognosis of the two groups will be compared. Obtain clinical data of PFUN in the Chinese population, and verify the safety and efficacy of PFUN for patients with femoral intertrochanteric fracture.
Who can participate
Age range18 Years – 100 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥18 years
✓. Patients with unilateral femoral intertrochanteric fractures that will be treated with internal fixation
✓. According to AO fracture classification, subjects with the fracture type (31-A)
✓. Subjects (with the help of relatives) can understand the informed documents and patient questionnaires.
✓. Subjects (with the help of relatives) voluntarily provide written informed consent to participate in the clinical study and authorize the transfer of their information to the sponsor.
✓. The investigator believes that the subject can understand the clinical study, is willing and able to complete all research procedures and followup visits and can cooperate with the research procedures.
✓. In-label use of the PFUN and PFNA.
Exclusion criteria
✕. Subject does not provide voluntary consent to participate in the study.
✕
What they're measuring
1
Internal fixation failure rate
Timeframe: from operation to 21-month follow-up after the surgery
. The researcher believes that the subjects have conditions that affect the participation and follow-up of this study. (for example, the patient lives in a remote area or has difficulty in going back to the hospital for follow-up or does not cooperate with the medical guidance and suggestions of the surgeon.)
✕. The subjects were pregnant or lactating women.
✕. The researchers believe that the subjects have psychological disorders, which may affect the treatment outcome.
✕. Subjects have significant neurological or musculoskeletal disorders or may have adverse effects on gait or weight-bearing (e.g., muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot arthropathy, avascular necrosis of the femoral head).
✕. Concurrent hip osteoarthritis.
✕. Fractures where the operative treatment will occur more than three weeks after the primary injury