A Prospective Multicenter Cohort Study About Internal Fixation Using PFUN Versus PFNA for Femoral Intertrochanteric Fracture
Status: Recruiting

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.

Eligibility:
- EligibilityCriteria: 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. 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 Patients combined with other bone fractures. Pathological fracture (e.g., primary or metastatic tumor) Serious soft tissue injury, judged by the investigator, will impact the union of the fracture, combined open fractures, vascular injury, and combined osteofascial compartment syndrome Multiple systemic injuries judged by researchers not suitable for enrollment. Revision surgeries (for example, due to malunion, nonunion or infection) Concurrent medical conditions judged by researchers not suitable for enrollment, such as: metabolic bone disease, post-polio syndrome, poor bone quality, prior history of poor fracture healing, etc Patients with anaesthetic and surgical contraindications Patients known to be allergic to implant components Patients who are currently using chemotherapeutics or accepting radiotherapy, use systematically corticosteroid hormone or growth factor, or long-term use sedative hypnotics (continuous use over 3 months) or non-steroidal anti-inflammatory drugs (continuous use over 3 months) Intemperance judged by researchers not suitable for enrollment (e.g., excessive daily drinking or smoking, drug abuse); Subjects participated in other clinical studies in the past 3 months, which may affect the outcome and follow-up according to the judgment of researchers. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult