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

NCT ID: NCT06713291

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2026-10-31

Brief Summary

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

Detailed Description

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Conditions

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Fracture of Femoral Neck

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Sliding compression locking plate

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

Group Type EXPERIMENTAL

Sliding compression locking plate

Intervention Type PROCEDURE

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

Three cannulated compression screws

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

Group Type PLACEBO_COMPARATOR

Three cannulated compression screws

Intervention Type PROCEDURE

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

Interventions

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Sliding compression locking plate

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

Intervention Type PROCEDURE

Three cannulated compression screws

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhang Wei

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chinese PLA General Hosptial

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Wei Zhang

Role: CONTACT

+8618612409252

Facility Contacts

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Meng Li

Role: primary

+8615334508850

Other Identifiers

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Chinese PLA General Hosptial

Identifier Type: -

Identifier Source: org_study_id