Influence of Static Distal Locking of a Short Proximal Femoral Nail

NCT ID: NCT06357312

Last Updated: 2024-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-04-01

Brief Summary

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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

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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.

Conditions

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Hip Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, comparative, randomized and double-blind study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Blinding of the patient included in the study and the investigator evaluating the results

Study Groups

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Group with distal screw

Patients who have been randomly selected for this procedure are included.

Group Type EXPERIMENTAL

hip trochanteric nail

Intervention Type DEVICE

hip trochanteric nail with and without distal interlocking screw

Group without distal screw

Patients who have been randomly selected for this procedure are included.

Group Type EXPERIMENTAL

hip trochanteric nail

Intervention Type DEVICE

hip trochanteric nail with and without distal interlocking screw

Interventions

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hip trochanteric nail

hip trochanteric nail with and without distal interlocking screw

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elda University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Francisco Antonio Miralles-Muñoz

Head of Department of Orthopedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos De la Pinta Zazo

Role: PRINCIPAL_INVESTIGATOR

Elda University Hospital

Locations

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Elda University Hospital

Elda, Valencia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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FRANCISCO ANTONIO MIRALLES MUÑOZ

Role: CONTACT

651552115

Facility Contacts

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FRANCISCO ANTONIO MIRALLES MUÑOZ

Role: primary

651552115

Other Identifiers

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2023/11P

Identifier Type: -

Identifier Source: org_study_id

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