Orthopedic Intelligent Navigation System in the Treatment of Fresh Femoral Neck Fractures

NCT ID: NCT06713018

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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2026-10-31

Brief Summary

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The goal of this clinical trial is to verify the safety and effectiveness of orthopaedic surgical navigation system in the treatment of fresh femoral neck fractures.

Participants will:

* Take three cannulated compression screws by navigation system or by traditional method to treat femoral neck fractures.
* Visit the clinic 1, 3, 6, 12 months after surgery for checkups and tests.

Detailed Description

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Conditions

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Fracture of Neck of Femur

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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Three cannulated compression screws by navigation system

Group Type EXPERIMENTAL

Three cannulated compression screws by navigation system

Intervention Type PROCEDURE

Patients with femoral neck fractures treated with three cannulated compression screws assisted by a navigation system

Traditional three cannulated compression screws

Group Type PLACEBO_COMPARATOR

Traditional three cannulated compression screws

Intervention Type PROCEDURE

Patients with femoral neck fractures treated with traditional three cannulated compression screws

Interventions

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Three cannulated compression screws by navigation system

Patients with femoral neck fractures treated with three cannulated compression screws assisted by a navigation system

Intervention Type PROCEDURE

Traditional three cannulated compression screws

Patients with femoral neck fractures treated with traditional 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

Deputy head of orthopedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chinese PLA General Hospital

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Wei Zhang

Role: CONTACT

+8612409252

Facility Contacts

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Meng Li

Role: primary

+8615334508850

Other Identifiers

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S2024-341-01

Identifier Type: -

Identifier Source: org_study_id