Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04869332
Status:
RECRUITING
Last Update Posted:
2021-05-03
First Post:
2021-04-09
Brief Title:
Three Cancellous Screws Versus Four Cancellous Screws for Femoral Neck Fixation
Sponsor:
Peking University Third Hospital
Organization:
Peking University Third Hospital
Study Overview
Official Title:
A Prospective Randomised Controlled Clinical Trial Three Cancellous Screws Versus Four Cancellous Screws for Fixation of Femoral Neck Fractures
Status:
RECRUITING
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective randomized controlled clinical study Patients with femoral neck fracture AO classification 31-B will be randomly divided into three-screw fixation group and four-screw fixation group The internal fixation failure rate IFFR and functional outcomes of the two groups will be compared and the patients will be followed up to 2 years after surgery
Detailed Description:
This is a prospective randomized controlled clinical trial All patients will be randomly divided into 2 groups at a ratio of 11 The investigators will use three screws for internal fixation in the first group and four screws for internal fixation in the second group The relevant parameters of the sample calculation are α 005 one-sided and β 02 PASS 15 was used for calculation and the final sample size was 290 145 for each group Subjects who meet all the inclusion conditions but do not meet any exclusion conditions and have signed the informed consent will be randomized and each patient will be assigned a unique patient identification number which will be used throughout the study Using a computer random allocation system eligible patients were randomly divided into the two groups at a ratio of 11 The investigators will perform preoperative preparations intraoperative operations and internal fixation in accordance with the instructions provided in the internal plant product packaging The investigators only plan to include cases in which closed reduction can be successfully performed so the investigators will exclude cases that require open reduction For the three-screw group three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck For the four-screw group the fourth screw will be implanted in the horizontal direction of the femoral distance on the basis of the three screws After the operation the subjects will be managed according to the standard nursing and rehabilitation procedures at the experimental site and the results of laboratory examinations will be recorded Regular follow-up evaluations will be carried out after the operation until the end of the two-year follow-up or the end of the study In this study the internal fixation failure rate IFFR will be used as the main research endpoint which is defined as the total incidence of cutouts fractures The results of the radiographic examination the lateral X-ray film and computed tomographyCT 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 X-ray 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 to randomization However considering that most of the patients may not have medical expertise if the researchers do not inform them the patients are the only people who may be blind Investigators will try their best to reduce human-induced bias in experimental results Investigators will use one-sided α 005 for statistical tests and confidence interval calculations P value 005 is considered statistically significant SPSS latest version SPSS Inc Chicago IL USA will be used to analyze the results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None