Actively Recruiting
A Prospective Multicenter Cohort Study About Internal Fixation Using Synthes Femoral Neck System (FNS) Versus Multiple Cancellous Screws (MCS) for Femoral Neck Fracture
Led by Peking University Third Hospital · Updated on 2021-10-22
290
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
P
Peking University Third Hospital
Lead Sponsor
S
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two types of internal fixation devices used to treat femoral neck fractures classified as AO 31-B. This study aims to evaluate and compare the failure rates and fracture healing outcomes between patients treated with the Femoral Neck System (FNS) and those treated with Multiple Cancellous Screws (MCS) over a two-year follow-up period. The study is a prospective multicenter cohort design, led by Peking University Third Hospital, and seeks to gather clinical data on FNS use in the Chinese population while assessing its safety and effectiveness. Participants are assigned to one of two groups based on the internal fixation method they choose: Group 1 receives the FNS device, which combines features of the dynamic hip screw and cancellous screws, designed to allow controlled fracture compression with a smaller implant footprint. Group 2 receives three cancellous screws arranged in an inverted triangle pattern to fix the femoral neck fracture. All procedures follow product instructions, and only cases suitable for closed reduction are included. After surgery, standard nursing and rehabilitation protocols are followed, with detailed recording of operation time, fluoroscopy use, and postoperative care. Patients will be monitored regularly over two years with clinical assessments and imaging such as X-rays and CT scans to evaluate internal fixation failure, bone healing, and adverse events like avascular necrosis or infection. Outcomes measured include the internal fixation failure rate, bone nonunion, hip function scores, operation details, and postoperative complications. The study uses independent radiological evaluation to determine implant performance and fracture healing, aiming to provide comprehensive safety and prognosis data for both fixation methods.
CONDITIONS
Brief Title
A Prospective Multicenter Cohort Study About Internal Fixation Using FNS Versus MCS for Femoral Neck Fracture
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patients with unilateral femoral neck fractures planned for internal fixation
- Femoral neck fracture classified as AO type 31-B
- Ability to understand informed consent and patient questionnaires, with or without help
- Voluntary written informed consent provided
- Willingness and ability to complete all study procedures and follow-ups
- Use of MCS or FNS devices as labeled
You will not qualify if you...
- No voluntary consent to participate
- Conditions affecting participation or follow-up, such as living in remote areas or poor cooperation
- Pregnant or breastfeeding women
- Psychological disorders affecting treatment outcome
- Garden classification III or IV fractures in patients over 65 years
- Concurrent hip osteoarthritis
- Surgery planned more than three weeks after injury
- Additional bone fractures
- Pathological fractures like tumors
- Serious soft tissue injuries impacting healing
- Multiple systemic injuries unsuitable for study
- Revision surgeries
- Medical conditions like metabolic bone disease or poor bone quality
- Contraindications to anesthesia or surgery
- Allergy to implant components
- Current use of chemotherapy, radiotherapy, long-term corticosteroids, sedatives, or NSAIDs
- Excessive alcohol, smoking, or drug abuse
- Participation in other clinical studies within past 3 months
- Significant neurological or musculoskeletal disorders affecting gait or weight-bearing ability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgical procedure day
Participants undergo internal fixation surgery using either the Synthes Femoral Neck System (FNS) or multiple cancellous screws (MCS) according to their chosen treatment group.
1 visit (in-person)
Duration - Up to 2 years after surgery
Participants receive standard nursing and rehabilitation care and are regularly followed up for clinical evaluations and imaging to monitor healing and detect any internal fixation failure or complications.
Regular follow-up visits until 2 years post-operation
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
Research Team
X
Xiangyu Xu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here