Medial Enhancement Technique for the Treatment of Old Femoral Neck Fractures

Launched by CHINESE PLA GENERAL HOSPITAL · Dec 1, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat old femoral neck fractures, which are breaks in the upper part of the thigh bone near the hip. The researchers want to see if a special technique that uses a combination of a specific screw and a support plate, along with bone grafting (a procedure that helps heal the bone), is safe and effective. This study will involve multiple centers and aims to help patients who have had these fractures for more than three weeks or who have not healed properly after previous treatment.

To participate in this trial, you need to be at least 18 years old and have a femoral neck fracture that hasn’t been treated surgically for more than three weeks. Participants will undergo surgery if they are able to tolerate it and will need to agree to take part in the study. However, there are some reasons that may prevent someone from joining, such as having certain medical conditions or not being able to understand the study fully. If eligible, participants can expect to receive careful monitoring and support throughout the trial as researchers gather information on the new treatment's effectiveness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \>= 18 years, gender not specified;
• • 2. 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;
• • 3. Have indications for internal fixation surgery for femoral neck fractures and are able to tolerate the surgery;
• • 4. Participants or their legal representatives are informed about the nature of this study and agree to participate.
• Exclusion Criteria:
• • 1. Participants who have not reached the primary endpoint of other drug, biological agent, or medical device clinical trials prior to enrollment;
• • 2. Known history of hypersensitivity to one or more implanted materials by the patient;
• • 3. Judged by the investigator as physically frail or unable to tolerate surgery due to other systemic diseases;
• • 4. Active infectious foci in the hip joint or other parts of the body, as judged by the investigator;
• • 5. Diagnosed with metabolic bone disease, radiation-induced bone disease, etc.;
• • 6. Severe hip contracture deformity or severe muscle weakness that has been immobilized in functional position for a long time and painless;
• • 7. Suffering from inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.;
• • 8. Patients who lack the mental capacity or understanding to meet the requirements of participating in the study, or are difficult to cooperate with;
• • 9. Other situations where the investigator deems the participant unsuitable for inclusion.