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NCT06357312 Clinical Trial

Influence of Static Distal Locking of a Short Proximal Femoral Nail

Hip Fracture Clinical Trial

Official title:
Influence of Static Distal Locking on Outcomes of Unstable Intertrochanteric Fracture Treated With a Short Proximal Femoral Nail

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06357312
Other study ID # 2023/11P
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date April 1, 2024

Study information
Verified date April 2024
Source Elda University Hospital
Contact FRANCISCO ANTONIO MIRALLES MUÑOZ
Phone 651552115
Email fr_miralles@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• hip trochanteric nail
hip trochanteric nail with and without distal interlocking screw

Locations
Country Name City State
Spain Elda University Hospital Elda Comunidad Valenciana

Sponsors (1)
Lead Sponsor Collaborator
Elda University Hospital

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of functional status using the Barthel index Evaluation of functional status 12 months after hip surgery 12 months
Secondary Postoperative mechanical complications Complication rate with nail, cephalic screw, or distal screw 12 months
Secondary Parker mobility scale Assessment of the patient's mobility capacity before and 12 months after hip surgery 12 months
See also
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Terminated NCT01667913 - Reliability of 6-Minutes Walking Test in Hip Fracture Patients N/A
Completed NCT01714336 - Does Tranexamic Acid Reduce the Need for Blood Transfusions in Patients Undergoing Hip Fracture Surgery? Phase 4
Terminated NCT01535781 - Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced? N/A
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Completed NCT02591342 - Comparison of a Cemented, Polished Tapered Stem and an Anatomic Stem for Femoral Neck Fracture N/A
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Completed NCT00848913 - Strength Training After Hip Fracture Surgery N/A
Completed NCT02190903 - A Trial To Assess Risk of Delirium in Older Adults Undergoing Hip Fracture Surgery With Spinal or General Anesthesia N/A