Does an Additional Antirotation U-Blade (RC) Lagscrew Improve Treatment of AO/OTA (Orthopaedic Trauma Association) 31 A1-3 Fractures With Gamma 3 Nail?

January 15, 2016 updated by: Julian Joestl, Medical University of Vienna

Does an Additional Antirotation U-Blade (RC) Lagscrew Improve Treatment of AO/OTA (Orthopaedic Trauma Association) 31 A1-3 Classified Fractures With Gamma 3 Nail?

The purpose was to evaluate whether the additional use of the Gamma3 ® RC Lag Screw is associated with a reduced cutout rate in patients with OTA/AO 31A1-3 inter-trochanteric fractures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

135

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with OTA/AO 31A1-3 fractures treated with Gamma 3® Nail (Stryker Trauma Germany) and either with standard lagscrews or with the Gamma3 ® RC Lag Screw (Stryker Trauma Germany)

Description

Inclusion Criteria:

  • OTA/AO 31A1-3 fractures treated with Gamma 3® Nail (Stryker Trauma Germany) and either with standard lagscrews or with the Gamma3 ® RC Lag Screw (Stryker Trauma Germany)

Exclusion Criteria:

  • Patients with pathological fractures
  • Patients treated with a long gamma nail were excluded

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gamma 3 Nail
Fractures that were treated with a Gamma 3 nail
Procedure: Fractures were treated with a Gamma 3 intramedullary nail
Gamma 3 Nail + U-Blade
Fractures that were treated with a Gamma 3 nail and additional with antirotation U-blade lag screws.
Procedure: Fractures were treated with a Gamma 3 intramedullary nail + U-Blade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cutout rate
Time Frame: 3 months after intervention
Differences in the Cutout rate of the femoral head screw with/without U-Blade antirational screw
3 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobility
Time Frame: 3 months after intervention
Mobility of the patients 3 months after intervention measured with the Parker mobility score
3 months after intervention

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

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

January 1, 2009

Primary Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

January 15, 2016

First Posted (ESTIMATE)

January 18, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2016

Last Update Submitted That Met QC Criteria

January 15, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1960/2015

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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