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A single-center prospective cohort study of proximal femoral bionic intramedullary nail and proximal femoral anti-rotation intramedullary nail in the treatment of unstable type between the rotor of the elderly femoral fractures

A single-center prospective cohort study of proximal femoral bionic intramedullary nail and proximal femoral anti-rotation intramedullary nail in the treatment of unstable type between the rotor of the elderly femoral fractures

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400089545
Enrollment
Unknown
Registered
2024-09-10
Start date
2024-09-10
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

intertrochanteric fracture

Interventions

PFBN group (Closed reduction and internal fixation of proximal femur with bionic intramedullary nail):None
PFNA group (Closed reduction and internal fixation of proximal femoral anti-rotation intramedullary nail):None

Sponsors

The Nanping First Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients =65 years of age, American Society of Anesthesiologists (ASA) Grade I-III, AO-OTA 31A2 or AO-OTA 31A3;treated with intramedullary fixation 2.Patients voluntarily participated in the study, signed informed consent forms, and were reviewed by ethics committees of all hospitals participating in the study.

Exclusion criteria

Exclusion criteria: 1.Patients younger than 65 years of age, patients with an intertrochanteric fracture of the femur with AO-OTA 31A1, prior hip abnormalities (e.g., Grade III osteoarthritis), American Society of Anesthesiologists IV Grade ,patients with pathological fractures, physical or medical conditions with limited walking, persistent infectious diseases, pre-existing ipsilateral femoral implants, or postoperative conditions affecting function in the contralateral hip. 2.Patients who were unable to obtain detailed demographic data and physical and chemical examination data related to the content of this study; 3.The investigator determined that the patient no longer met the study criteria due to compliance issues; 4.Such as combination of tumor, important viscera function failure may affect the results of the study of disease.

Design outcomes

Primary

MeasureTime frame
The operation time; Intraoperative blood loss;Hospital stay;Femoral neck-shaft Angle;Quality of intraoperative reduction;Bone mineral density;Postoperative weight-bearing time;Postoperative weight-bearing time;Postoperative Harris score;Postoperative VAS score;Cut out with a spiral blade;the leaving bed time;

Secondary

MeasureTime frame
Nonunion or delayed union of the fracture;Internal fixation loosening;Internal fixation fracture;Lung infection;urinary tract infection;pressure sores;Deep venous thrombosis of the lower extremities occurred;

Countries

China

Contacts

Public ContactKabin Zeng

The Nanping First Hospital of Fujian Medical University

zengkabin_npyy@sina.com+86 150 5995 0116

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026