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Medial Enhancement Technique for the Treatment of Old Femoral Neck Fractures

NCT ID: NCT06713031

Last Updated: 2024-12-04

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

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2026-10-31

Brief Summary

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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.

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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Cannulated compression screws + iliac bone graft group

Group Type PLACEBO_COMPARATOR

cannulated compression screws + iliac bone graft

Intervention Type PROCEDURE

Using "cannulated compression screws + iliac bone graft" technique to treat old femoral neck fractures

DCS + medial support plate + iliac bone graft group

Group Type EXPERIMENTAL

DCS + medial support plate + iliac bone graft

Intervention Type PROCEDURE

Using "DCS + medial support plate + iliac bone graft" technique to treat old femoral neck fractures

Interventions

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cannulated compression screws + iliac bone graft

Using "cannulated compression screws + iliac bone graft" technique to treat old femoral neck fractures

Intervention Type PROCEDURE

DCS + medial support plate + iliac bone graft

Using "DCS + medial support plate + iliac bone graft" technique to treat old femoral neck fractures

Intervention Type PROCEDURE

Eligibility Criteria

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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.
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 Hosptial

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Wei Zhang

Role: CONTACT

[email protected]
+8612409252

Other Identifiers

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S2024-342-01

Identifier Type: -

Identifier Source: org_study_id