Medial Enhancement Technique for the Treatment of Old Femoral Neck Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cannulated compression screws + iliac bone graft, DCS + medial support plate + iliac bone graft.
- Who it may be relevant to
- Registry conditions: Fracture of Neck of Femur. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective, Multicenter, Randomized Controlled Clinical Study of Medial Enhancement Technique for the Treatment of Old Femoral Neck Fractures
Overview
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.
Interventions
- Procedure cannulated compression screws + iliac bone graft
Using "cannulated compression screws + iliac bone graft" technique to treat old femoral neck fractures - Procedure DCS + medial support plate + iliac bone graft
Using "DCS + medial support plate + iliac bone graft" technique to treat old femoral neck fractures
Primary outcome measures
- Fracture healing rate [Time frame: 1 year]
Secondary outcome measures (4)
- Femoral head necrosis [Time frame: 1 year]
- Harris score [Time frame: 1 year]
- VAS score [Time frame: 1 year]
- Complications [Time frame: 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese PLA General Hosptial — Beijing
Identifiers
NCT: NCT06713031 · S2024-342-01