Short Versus Long Cephalomedullary Nailing of Pertrochanteric Hip Fractures: A Randomized Prospective Study

May 11, 2023 updated by: Stephen A. Sems, Mayo Clinic
Is there a functional outcome difference when treating pertrochanteric fractures with a short or long cephalomedullary nail?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

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 Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • AO/OTA fracture classification 31(A-B) (1-3).
  • Age greater than 18 years old.

Exclusion Criteria

-Less than 18 years old.

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
Active Comparator: Short nail implant
used to treat pertrochanteric fractures
Procedure: Short versus long cephalomedullary Intramedullary nail
Biomet Affixus Short and Long hip fracture nail. Stryker Gamma Short and Long hip fracture nail.
Active Comparator: Long nail implant
used to treat pertrochanteric fractures
Procedure: Short versus long cephalomedullary Intramedullary nail
Biomet Affixus Short and Long hip fracture nail. Stryker Gamma Short and Long hip fracture nail.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SF (short form)-36
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Harris Hip Score
Time Frame: 3 months
3 months

Other Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 1 year
1 year
Reoperation
Time Frame: within 1 year
within 1 year

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Stephen Sems, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

November 1, 2014

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

November 4, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimate)

November 6, 2014

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-002490

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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