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Prospective, multicenter, randomized controlled clinical study of medial enhancement technique for the treatment of old femoral neck fractures

Prospective, multicenter, randomized controlled clinical study of medial enhancement technique for the treatment of old femoral neck fractures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092400
Enrollment
Unknown
Registered
2024-11-15
Start date
2024-11-18
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fracture of neck of femur

Interventions

cannulated compression screws + iliac bone graft group:Using "cannulated compression screws + iliac bone graft" technique to treat old femoral neck fractures
DCS + medial support plate + iliac bone graft group:Using "DCS + medial support plate + iliac bone graft" technique to treat old femoral neck fractures

Sponsors

Chinese PLA General Hosptial
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Fracture healing rate;

Secondary

MeasureTime frame
Femoral head necrosis;Harris score;VAS score;Complications;

Countries

China

Contacts

Public ContactWei Zhang

Chinese PLA General Hosptial

bszw@hotmail.com+86 186 1240 9252

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026