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

NCT06713018 | Not Yet Recruiting DMC

• 1 other identifier: S2024-341-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fracture of Neck of Femur

Keywords

orthopedic intelligent navigation system

Outcome Measures

Primary Outcomes (1)

• Perspective frequency

  Document the total number of intraoperative fluoroscopy sessions taken during surgery, including each anteroposterior and lateral fluoroscopic image

  1 day

Secondary Outcomes (9)

• Neck shaft angle

  1 year

• Guide needle implantation effect

  1 day

• Fluoroscopy times of needle implantation

  1 day

• Operation time

  1 day

• Operative blood loss

  1 day

Study Arms (2)

Three cannulated compression screws by navigation system

EXPERIMENTAL

Procedure: Three cannulated compression screws by navigation system

Traditional three cannulated compression screws

PLACEBO COMPARATOR

Procedure: Traditional three cannulated compression screws

Interventions

Three cannulated compression screws by navigation system PROCEDURE

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

Three cannulated compression screws by navigation system

Traditional three cannulated compression screws PROCEDURE

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

Traditional three cannulated compression screws

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 (1)

Chinese PLA General Hospital

Beijing, China

Location

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

+8612409252; 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: Deputy head of orthopedics

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: December 3, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)