Influence of Static Distal Locking of a Short Proximal Femoral Nail

Not Applicable

Recruiting

• Conditions: Hip Fracture

• Registration Number: NCT06357312
• Lead Sponsor: Elda University Hospital

Brief Summary

Prospective, comparative, randomized, double-blind study to evaluate the outcomes of trochanteric nailing in unstable hip fractures with and without a distal interlocking screw.

Detailed Description

Due to the lack of first-level evidence, this study aims to evaluate the effectiveness and safety of surgical treatment for unstable hip fractures, with or without the inclusion of a distal interlocking screw in the hip nail.

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01
• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Study First Posted: 2024-04-10
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patient over 50 years old
• With unstable intertrochanteric hip fracture
• Operated in the first 48 hours after hospital admission

Exclusion Criteria

• Simultaneous associated fractures
• Fractures with subtrochanteric line
• Non-acute fractures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of functional status using the Barthel index	12 months	Evaluation of functional status 12 months after hip surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative mechanical complications	12 months	Complication rate with nail, cephalic screw, or distal screw
Parker mobility scale	12 months	Assessment of the patient's mobility capacity before and 12 months after hip surgery

Trial Locations

Locations (1)

Elda University Hospital; 🇪🇸 Elda, Comunidad Valenciana, Spain