Femoral Neck Fractures Clinical Trial
Official title:
A Prospective Randomised Controlled Clinical Trial: Three Cancellous Screws Versus Four Cancellous Screws for Fixation of Femoral Neck Fractures
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.
Status | Recruiting |
Enrollment | 290 |
Est. completion date | December 31, 2026 |
Est. primary completion date | April 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age =18 years - Patients with unilateral femoral neck fractures that will be treated with internal fixation - According to AO fracture classification, subjects with the fracture type (31-B) - 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 follow-up visits and can cooperate with the research procedures. - In-label use of the MCS. 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. - Garden classification III and IV of femoral neck fracture patients older than 65 years - Concurrent hip osteoarthritis. - Fractures where the operative treatment will occur more than three weeks after the primary injury - Patients combined with femoral head fractures(31-C), femoral shaft fractures(32-A/B/C) or femoral trochanteric area fracture (31-A1/A2/A3). - Pathological fracture (e.g., primary or metastatic tumor) - Serious soft tissue injury, judged by the investigator, will impact the union of the fracture, combined 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. - 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). |
Country | Name | City | State |
---|---|---|---|
China | Peking University Third Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University Third Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Internal fixation failure rate | defined as the total incidence of internal plant cut-out and fracture | from operation to 2-year follow-up after the surgery | |
Secondary | Number of Participants with Bone nonunion | evaluate bone healing according to the lateral X-ray examination. According to the regulations of Food and Drug Administration of the US, 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, it is defined as nonunion. | from operation to 9-month follow-up after the surgery | |
Secondary | Harris hip score | the score value is from 0 to 100, and a higher score means a better outcome | from operation to 2-year follow-up after the surgery | |
Secondary | operation time | from the incision to internal fixation implanted. | intraoperative | |
Secondary | The times of intraoperative fluoroscopy | average 25 milliseconds per X-ray shot, record the number of X-ray shot | intraoperative | |
Secondary | Garden index | The fracture reduction will be considered unsatisfied if the index is less than 155 degrees or more than 180 degrees. | from operation to 2-year follow-up after the surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05505604 -
PENG vs FICB for Hip Fracture in ED Patients
|
N/A | |
Recruiting |
NCT04462172 -
A Prospective Multicenter Cohort Study About Internal Fixation Using FNS Versus MCS for Femoral Neck Fracture
|
N/A | |
Enrolling by invitation |
NCT04110639 -
Intraoperative Monitoring of Femoral Head Perfusion
|
N/A | |
Terminated |
NCT01908751 -
Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2)
|
Phase 3 | |
Recruiting |
NCT01934049 -
Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty
|
Phase 4 | |
Recruiting |
NCT01219088 -
Intrathecal Morphine,Femoral Nerve Block,Periarticular Bupivacaine Infiltration for Pain After Intramedullary Hip Screw
|
Phase 4 | |
Not yet recruiting |
NCT00749710 -
Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel
|
N/A | |
Active, not recruiting |
NCT00491673 -
A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures
|
N/A | |
Completed |
NCT00464230 -
Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures
|
Phase 4 | |
Recruiting |
NCT03966716 -
Hips Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients (HipSTHeR)
|
N/A | |
Recruiting |
NCT05227924 -
Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
|
||
Completed |
NCT03666637 -
Femoral Neck Fracture in Adult and Avascular Necrosis and Nonunion
|
||
Terminated |
NCT03721835 -
Safety Study of Femoral Neck Fracture System
|
N/A | |
Not yet recruiting |
NCT04408053 -
Mini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture
|
Phase 3 | |
Recruiting |
NCT04577261 -
FNS (FEMORAL NECK SYSTEM) Study
|
||
Recruiting |
NCT04589598 -
Femoral Neck System and Multiple Cannulated Screws in Femoral Neck Fracture
|
N/A | |
Not yet recruiting |
NCT06078371 -
Opioid-Free Pain Treatment in Trauma Patients
|
N/A | |
Withdrawn |
NCT02198820 -
Practice Survey on Femoral Neck Fractures and the Incidence of Type of Anesthesia on Patient Outcome
|
N/A | |
Active, not recruiting |
NCT02246335 -
Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly
|
N/A | |
Not yet recruiting |
NCT00926666 -
A Dose Finding Study for Pain Relief of a Broken Hip
|
Phase 4 |