Medial Enhancement Technique for the Treatment of Old Femoral Neck Fractures

Chinese PLA General Hospital (301 Hospital)

Status: Not yet enrolling

Conditions: Fracture of Neck of Femur

Treatments: Procedure: cannulated compression screws + iliac bone graft; Procedure: DCS + medial support plate + iliac bone graft

Study type: Interventional

Funder types: Other

Identifiers

NCT06713031

S2024-342-01

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

400 participants in 2 patient groups, including a placebo group

Cannulated compression screws + iliac bone graft group

Placebo Comparator group

Treatment:

Procedure: cannulated compression screws + iliac bone graft

DCS + medial support plate + iliac bone graft group

Experimental group

Treatment:

Procedure: DCS + medial support plate + iliac bone graft