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A Prospective Multicenter Randomazied Controlled Trial about Using Femoral Neck System Versus Cannulated Screws with Medial Plate for Femoral Neck Fracture

A Prospective Multicenter Randomazied Controlled Trial about Using Femoral Neck System Versus Cannulated Screws with Medial Plate for Femoral Neck Fracture

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042960
Enrollment
Unknown
Registered
2021-02-01
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-05-17

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

Conditions

Femoral Neck Fracture

Interventions

Experimental group:femoral neck system
control group:cannulated screws with medial plate

Sponsors

Qingdao Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of femoral neck fracture; 2. Aged >= 18 years; 3. New unilateral femoral neck fracture patients were treated with internal fixation; 4. According to Ao fracture classification, fracture type (31-b); 5. Subjects (with the help of relatives) can understand the informed documents and patient questionnaire; 6. The time from injury to operation is less than 3 weeks; 7. The follow-up time is more than 2 years; 8. Informed consent of patients and their families, voluntary participation.

Exclusion criteria

Exclusion criteria: 1. Pathological fracture (such as primary or metastatic tumor); 2. Pregnant or lactating women; 3. Combined with femoral head fracture (31-c), femoral shaft fracture (32-a / B / C) or femoral intertrochanteric fracture (31-a1 / A2 / A3); 4. Severe soft tissue injury and multiple systemic injury; 5. Complicated with hip osteoarthritis, metabolic osteopathy, post poliomyelitis syndrome, poor bone quality, previous history of poor fracture healing, etc.; 6. Patients with contraindications to anesthesia and surgery; 7. Patients allergic to implant components; 8. Patients with mental illness or cognitive impairment; 9. Patients with obvious neuroskeletal or musculoskeletal diseases; 10. Patients who are currently using chemotherapy drugs or receiving radiotherapy, systemic use of corticosteroids or growth factors, or long-term use of sedative hypnotics (continuous use for more than 3 months) or non steroidal anti-inflammatory drugs (continuous use for more than 3 months); 11. Participated in other clinical researchers in the past 3 months.

Design outcomes

Primary

MeasureTime frame
Internal fixation failure rate;Harris score;fracture union time;

Secondary

MeasureTime frame
Number of patients with bone nonunion after surgery;operation time;Intraoperative blood loss;The times of intraoperative fluoroscopy;Garden Index;Number of adverse events after surgery;A 12-Item Short-Form Health Survey;

Countries

China

Contacts

Public ContactChengke Lao

Qingdao Municipal Hospital

laokecheng89@163.com+86 13675328181

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026