Chinese PLA General Hospital
Beijing, China
NCT Number: NCT06713018
The goal of this clinical trial is to verify the safety and effectiveness of orthopaedic surgical navigation system in the treatment of fresh femoral neck fractures.
Participants will:
* Take three cannulated compression screws by navigation system or by traditional method to treat femoral neck fractures. * Visit the clinic 1, 3, 6, 12 months after surgery for checkups and tests.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with femoral neck fractures treated with three cannulated compression screws assisted by a navigation system
Patients with femoral neck fractures treated with traditional three cannulated compression screws
Time frame: 1 day
Document the total number of intraoperative fluoroscopy sessions taken during surgery, including each anteroposterior and lateral fluoroscopic image
Time frame: 1 year
Time frame: 1 day
For the group treated with three hollow compression screws, the effect of the implantation of guide pins is categorized into three parallel pins, two parallel pins, and mutually non-parallel pins, with measurements taken during the surgery.
Time frame: 1 day
Time frame: 1 day
Time frame: 1 day
Time frame: 1 year
Postoperative follow-up observation is conducted for all patients, with anteroposterior and lateral hip X-rays taken at the 1st, 3rd, 6th, and 12th postoperative months. X ray and CT scans are reviewed at the 1st and 3rd postoperative months to observe the stability of the implanted internal fixation, the disappearance of the fracture line, and whether there is displacement of the fracture ends.
Time frame: 1 year
The Zarit Burden Interview (ZBI) is a commonly used assessment tool designed to quantify the psychological and emotional burden experienced by caregivers who provide care for individuals with cognitive or functional impairments. Developed by Zarit and colleagues, the scale consists of 22 items that cover various aspects of caregiver burden, such as time pressure, emotional strain, and social isolation. The scoring ranges from 0 to 88, with higher scores indicating a greater level of caregiving burden. This tool aids healthcare professionals in identifying the psychological stress faced by caregivers and provides appropriate support and interventions to improve their mental health and quality of life.
Time frame: 1 year
The Harris Score (Harris Hip Score, HHS) is a widely used scale for evaluating hip joint function and patient quality of life, often applied to assess the outcomes of hip replacement surgery or other treatments for hip joint diseases. It covers four main aspects: pain level, functional activity, joint range of motion, and hip joint deformity. The total score ranges from 0 to 100, with 100 being the best possible condition, indicating complete normalcy of hip joint function.
Time frame: 1 year
The SF-36 (Short Form 36 Health Survey) is a widely used generic health status assessment tool developed by the Medical Outcomes Study (MOS) Group. The scale is designed to comprehensively evaluate health-related quality of life, encompassing eight dimensions: physical functioning, social functioning, role limitations due to physical health, role limitations due to emotional problems, bodily pain, mental health, vitality, and general health perceptions. Each dimension consists of several items, and scores are derived by summing the scores of these items, typically converted to a 0 to 100 percent scale, with 100 representing the best possible health state. These eight dimension scores can be combined to form two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Contact information is provided by the study sponsor or research team.
Chinese PLA General Hospital
Other
Prospective, Multicenter, Randomized Controlled Clinical Study of Orthopedic Intelligent Navigation System in the Treatment of Fresh Femoral Neck Fractures
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