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

NCT06713291 | Recruiting DMC

• 1 other identifier: Chinese PLA General Hosptial
• Study Type: interventional
• Target: 1,150
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Fracture of Femoral Neck

Keywords

fracture of neck of femur, sliding compression locking plate, compression screws

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Neck shaft angle

  1 year

• The effectiveness of guide pin implantation

  1 day

• Time of operation

  1 day

• Blood loss

  1 day

• Bone union

  1 year

Study Arms (2)

Sliding compression locking plate

EXPERIMENTAL

Patients with femoral neck fracture were treated with sliding compression locking plate internal fixation.

Procedure: Sliding compression locking plate

Three cannulated compression screws

PLACEBO COMPARATOR

The patients with femoral neck fracture were treated with three cannulated compression screws.

Procedure: Three cannulated compression screws

Interventions

Three cannulated compression screws PROCEDURE

The patients with femoral neck fracture were treated with three cannulated compression screws.

Three cannulated compression screws

Sliding compression locking plate PROCEDURE

The patients with femoral neck fracture were treated with three cannulated compression screws or sliding compression locking plate.

Sliding compression locking plate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=18 years old, gender is not limited;
• Patients diagnosed with femoral neck fracture;
• Patients with indications for internal fixation of femoral neck fracture and able to tolerate surgery;
• The subject or his legal representative is informed of the nature of the study and agrees to participate in the study.

You may not qualify if:

• 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;
• The patient is known to have a history of allergy to one or more implanted materials;
• Patients determined by researchers to be physically weak or unable to tolerate surgery due to other systemic diseases;
• Active infection of the hip joint or other parts of the body is determined by the investigator;
• Diagnosed as metabolic bone disease, radiation bone disease, etc.;
• Severe hip contracture deformity or severe muscle loss fused to the functional position for a long time without pain;
• have inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.;
• The patient is mentally incapable or unable to understand the requirements of participating in the study, and it is difficult to cooperate;

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (3)

the First Centre of PLA General Hospital

Beijing, Beijing Municipality, 100048, China

RECRUITING

Chinese PLA General Hosptial

Beijing, China

NOT YET RECRUITING

the First Medical Center of PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Central Study Contacts

Wei Zhang

CONTACT

+8618612409252; bszw@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2024
• First Posted: December 3, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)