Prospective, Multicenter, Randomized Controlled Clinical Study of Medial Enhancement Technique for the Treatment of Old Femoral Neck Fractures

Chinese PLA General Hospital1 site in 1 country400 target enrollmentDecember 10, 2024

ConditionsFracture of Neck of Femur

Overview

Phase: N/A
Intervention: Not specified
Conditions: Fracture of Neck of Femur
Sponsor: Chinese PLA General Hospital
Enrollment: 400
Locations: 1
Primary Endpoint: Fracture healing rate
Status: Not Yet Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A prospective, multi-center, randomized controlled study was conducted to validate the safety and effectiveness of employing the medial augmentation technique (incorporating the dynamic condylar screw and medial support plate) supplemented with bone grafting for the treatment of old femoral neck fractures.

Registry

clinicaltrials.gov

Start Date

December 10, 2024

End Date

October 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chinese PLA General Hospital

Responsible Party

Principal Investigator

Zhang Wei

Deputy head of orthopedics

Chinese PLA General Hospital

Eligibility Criteria

Inclusion Criteria

•Age \>= 18 years, gender not specified;
•Patients with femoral neck fractures who have not undergone surgery for more than 3 weeks, or patients with persistent non-union following internal fixation of femoral neck fractures;
•Have indications for internal fixation surgery for femoral neck fractures and are able to tolerate the surgery;
•Participants or their legal representatives are informed about the nature of this study and agree to participate.

Exclusion Criteria

•Participants who have not reached the primary endpoint of other drug, biological agent, or medical device clinical trials prior to enrollment;
•Known history of hypersensitivity to one or more implanted materials by the patient;
•Judged by the investigator as physically frail or unable to tolerate surgery due to other systemic diseases;
•Active infectious foci in the hip joint or other parts of the body, as judged by the investigator;
•Diagnosed with metabolic bone disease, radiation-induced bone disease, etc.;
•Severe hip contracture deformity or severe muscle weakness that has been immobilized in functional position for a long time and painless;
•Suffering from inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.;
•Patients who lack the mental capacity or understanding to meet the requirements of participating in the study, or are difficult to cooperate with;
•Other situations where the investigator deems the participant unsuitable for inclusion.