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

Prospective, Multicenter, Randomized Controlled Clinical Study of a Novel Sliding Compression Locking Plate in the Treatment of Fresh Femoral Neck Fractures

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

Study Overview

• Status: Recruiting
• Conditions: Fracture of Femoral Neck
• Intervention / Treatment: Procedure: Sliding compression locking plate; Procedure: Three cannulated compression screws

• Study Type: Interventional
• Enrollment (Estimated): 1150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Zhang; Phone Number: +8618612409252; Email: bszw@hotmail.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • The First Medical Center of PLA General Hospital
    • Contact: Wei 66848653 Zhang; Phone Number: +8615334508850; Email: zhangwei@301hospital.com.cn
  • Beijing, China
    • Not yet recruiting
    • Chinese PLA General Hosptial
    • Contact: Meng Li; Phone Number: +8615334508850; Email: limeng1@301hospital.com.cn
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100048
      • Recruiting
      • the First Centre of PLA General Hospital
      • Contact: Wei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sliding compression locking plate; Patients with femoral neck fracture were treated with sliding compression locking plate internal fixation.	Procedure: Sliding compression locking plate; The patients with femoral neck fracture were treated with three cannulated compression screws or sliding compression locking plate.
Placebo Comparator: Three cannulated compression screws; The patients with femoral neck fracture were treated with three cannulated compression screws.	Procedure: Three cannulated compression screws; The patients with femoral neck fracture were treated with three cannulated compression screws.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Femoral neck shortened	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss		1 day
Neck shaft angle		1 year
The effectiveness of guide pin implantation	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.	1 day
Time of operation		1 day
Bone union		1 year
Zarit Burden Interview（ZBI）	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.	1 year
SF-36 Score	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).	1 year
Harris Hip Score:	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.	hip function is assessed during outpatient follow-up at 1, 3, 6, and 12 months postoperatively using the Harris Hip Score system.

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: November 16, 2024
• First Submitted That Met QC Criteria: December 1, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: fracture of neck of femur, sliding compression locking plate, compression screws
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Hip Fractures; Femoral Neck Fractures
• Other Study ID Numbers: Chinese PLA General Hosptial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No