Clinical Study of a Novel Sliding Compression Locking Plate in the Treatment of Fresh Femoral Neck Fractures

Not Applicable

Not yet recruiting

• Conditions: Fracture of Femoral Neck

• Registration Number: NCT06713291
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

To verify the safety and efficacy of sliding compression locking plates in the treatment of fresh femoral neck fractures

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-16
• Study First Submitted QC: 2024-12-01
• Last Update Submitted: 2024-12-01
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03
• Study Start: 2024-12-10
• Primary Completion: 2026-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.

Trial Locations

Locations (1)

Chinese PLA General Hosptial; 🇨🇳 Beijing, China