Influence of Static Distal Locking of a Short Proximal Femoral Nail

April 4, 2024 updated by: Francisco Antonio Miralles-Muñoz, Elda University Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Comunidad Valenciana
      • Elda, Comunidad Valenciana, Spain, 03600
        • Recruiting
        • Elda University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group with distal screw
Patients who have been randomly selected for this procedure are included.
Device: hip trochanteric nail
hip trochanteric nail with and without distal interlocking screw
Experimental: Group without distal screw
Patients who have been randomly selected for this procedure are included.
Device: hip trochanteric nail
hip trochanteric nail with and without distal interlocking screw

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of functional status using the Barthel index
Time Frame: 12 months
Evaluation of functional status 12 months after hip surgery
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elda University Hospital

Investigators

  • Principal Investigator: Carlos De la Pinta Zazo, Elda University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

April 4, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/11P

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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