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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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