PFNA vs Dual Mobility in Treatment of Unstable Trochanteric Fractures

January 9, 2023 updated by: Marcos Hanna Morris, Cairo University

The Usage Of Proximal Femoral Nail Versus Dual Mobility Arthroplasty In Treatment Of Unstable Trochanteric Fractures

Proximal femoral nail [PFNA] versus dual mobility arthroplasty in treatment of unstable trochanteric fractures

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

compare clinial outcome between two different procdures either using pfna or arthroplasty in the treatment of unstable trochaneric fractures

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

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

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

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with trochanteric unstable fractures.
  • age 60 or above
  • recent fracture time within 2 weeks time period
  • trochanteric starting point in pfna
  • patients medical condition is stable

Exclusion Criteria:

  • stable trochanteric fractures
  • delayed or neglected fractures
  • unstable patients medical conditions
  • pirformis fossa starting point in pfna

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: proximal femoral nail
20 patient with trochanteric fractures , unstable type will use proximal femoral nail
Device: Proximal Femoral Nail
open reduction
Other Names:
  • PFNA
Active Comparator: Dual Mobility Arthroplasty
20 patient with trochanteric fractures , unstable type will use dual mobility arthroplasty
Combination product: Dual Mobility Arthroplasty
Hip Arthroplasty Surgery
Other Names:
  • THA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hip score
Time Frame: Through study completion, an average of 1 year"
compare between hip score in first group of pfna versus hip score in second group of THA
Through study completion, an average of 1 year"
Operation time
Time Frame: During surgery
compartive operative time between first group of pfna versus second group of THA
During surgery

Collaborators and Investigators

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

Sponsor

Cairo University

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 (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

November 23, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • orthopedic

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

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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