Femoral Intertrochanteric Fractures Clinical Trial
Official title:
A Prospective Multicenter Cohort Study About Internal Fixation Using Proximal Femoral Universal Nail (PFUN) Versus Proximal Femoral Nail Antirotation (PFNA) for Femoral Intertrochanteric Fracture
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.
This is a prospective multicenter cohort study. The team leader is Peking University Third Hospital. All patients are divided into 2 groups according to the internal fixation they choose. Investigators use PFUN for internal fixation in Group 1 and PFNA in Group 2. The relevant parameters of the sample calculation are α = 0.05 (one-sided) and β = 0.2. PASS 15 was used for calculation, and the final sample size was 130. The PFUN group and the PFNA group each included 65 patients. See the text for detailed inclusion and exclusion criteria. Patients that meet all the inclusion criteria but do not meet any exclusion criteria, and who have signed the informed consent will be recruited, and each patient will be assigned a unique patient identification number, which will be used throughout the study identify the patient. Investigators will perform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging. Investigators only plan to include cases that can successfully conduct closed reduction, therefore investigators will exclude cases that require open reduction. After the operation, the patients will be managed according to the standard nursing and rehabilitation procedures of the experimental site and the results of laboratory tests will be recorded. Regular follow-up evaluation will be performed after the operation until the end of the 21-month follow-up or the primary end point of the study. In this study, the internal fixation failure rate (IFFR) is used as the primary end point of the study, which is defined as the total incidence of internal plant cut-out and fracture. The results of the radiographic examination, the lateral X-ray film and computed tomography(CT), will be evaluated by an independent radiologist to determine whether there are cut-out or fracture of the internal plant. Secondary endpoints include: 1. Bone nonunion after 36 weeks: evaluate bone healing according to the lateral X-ray examination. According to the regulations of Food and Drug Administration of the US, it is defined as nonunion if there are no obvious signs of fracture healing 9 months after the fracture, or if there is no obvious difference in fracture space after three consecutive months. 2. Garden classification proportion, and Garden index for reduction assessment. 3. Clinical prognosis: o A 12-Item Short-Form Health Survey (SF-12) o Harris hip score. 4. Operation time, from the incision to internal fixation implanted. 5. The times of intraoperative fluoroscopy, average 25 milliseconds per Xray shot, record the number of X-ray shot. 6. Postoperative adverse events within 2 years, including ipsilateral femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and ipsilateral limb shortening. In this study, it is difficult to blind anyone . Investigators will try their best to reduce human-induced bias in experimental results. Investigators will use one-sided α = 0.05 for statistical tests and confidence interval calculations. P value <0.05 is considered statistically significant. SPSS (latest version: SPSS Inc., Chicago, IL, USA) will be used to analyze the results ;