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A multicenter prospective randomized controlled study of proximal femoral bionic intramedullary nail and proximal femoral anti-rotation intramedullary nail in the treatment of intertrochanteric fractures

A multicenter prospective randomized controlled study of proximal femoral bionic intramedullary nail and proximal femoral anti-rotation intramedullary nail in the treatment of intertrochanteric fractures

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053853
Enrollment
Unknown
Registered
2021-12-01
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-31

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

Conditions

Intercondylar ridge fracture of the tibial plateau

Interventions

PFBN group:Closed reduction and internal fixation of proximal femur with bionic intramedullary nail
PFNA group:Closed reduction and internal fixation of proximal femoral anti-rotation intramedullary nail

Sponsors

The Third Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients; 2. Diagnosed as intertrochanteric fracture of femur by imaging examination; 3. Primary fracture; 4. Unilateral, closed fracture; 5. Patients received the randomly assigned treatment plan and follow-up requirements, and they all gave informed consent to this study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Serious dislocation or necrosis of the femoral head; 2. Combined with important organ damage or serious disease; 3. There is obvious coagulation dysfunction; 4. Combined with fractures of other parts of the lower extremity on the same side; 5. Combined with cognitive impairment or mental disorder.

Design outcomes

Primary

MeasureTime frame
The operation time;Intraoperative blood loss;Hospital stay;Postoperative weight-bearing time;Fracture healing time;Postoperative Harris score;Postoperative satisfaction rate;The distance between the tip and the top;

Secondary

MeasureTime frame
Hip pain;Nonunion or delayed union of the fracture;Internal fixation loosening;Lung infection;Urinary tract infection;Bedsore and pulmonary embolism;

Countries

China

Contacts

Public ContactZhang Yingze

The Third Hospital of Hebei Medical University

drzyzhangyingze@163.com+86 311 88603682

Outcome results

None listed

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