Fracture of Femoral Neck
Conditions
Keywords
fracture of neck of femur, sliding compression locking plate, compression screws
Brief summary
To verify the safety and efficacy of sliding compression locking plates in the treatment of fresh femoral neck fractures
Interventions
PROCEDURESliding compression locking plate
The patients with femoral neck fracture were treated with three cannulated compression screws or sliding compression locking plate.
PROCEDUREThree cannulated compression screws
The patients with femoral neck fracture were treated with three cannulated compression screws.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>=18 years old, gender is not limited; 2. Patients diagnosed with femoral neck fracture; 3. Patients with indications for internal fixation of femoral neck fracture and able to tolerate surgery; 4. The subject or his legal representative is informed of the nature of the study and agrees to participate in the study.
Exclusion criteria
1. Participants who had participated in clinical studies of other drugs, biologics or medical devices before enrollment and did not reach the primary study endpoint time limit; 2. The patient is known to have a history of allergy to one or more implanted materials; 3. Patients determined by researchers to be physically weak or unable to tolerate surgery due to other systemic diseases; 4. Active infection of the hip joint or other parts of the body is determined by the investigator; 5. Diagnosed as metabolic bone disease, radiation bone disease, etc.; 6. Severe hip contracture deformity or severe muscle loss fused to the functional position for a long time without pain; 7. have inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.; 8. The patient is mentally incapable or unable to understand the requirements of participating in the study, and it is difficult to cooperate; 9. Other conditions deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Femoral neck shortened | 1 year | The difference in femoral neck length between 1 week post-surgery and 6 months and 12 months post-surgery, measured via X-ray and CT imaging examinations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neck shaft angle | 1 year | — |
| The effectiveness of guide pin implantation | 1 day | For the cohort treated with three cannulated compression screws, the effectiveness of guide pin implantation is categorized into three parallel, two parallel, and non-parallel arrangements，which will be measured during the surgery. |
| Time of operation | 1 day | — |
| Blood loss | 1 day | — |
| Bone union | 1 year | — |
| Zarit Burden Interview（ZBI） | 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. |
| SF-36 Score | 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). |
| Harris Hip Score: | hip function is assessed during outpatient follow-up at 1, 3, 6, and 12 months postoperatively using the Harris Hip Score system. | The Harris Hip Score is a clinician-reported outcome measure assessing hip function, including pain, function, absence of deformity, and range of motion, used to evaluate outcomes after hip surgery. |
Countries
China
Contacts
CONTACTWei Zhang
Outcome results
None listed