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

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ClinicalTrials.gov Identifier: NCT02657902
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Julian Joestl, Medical University of Vienna

Brief Summary:
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.

Condition or disease Intervention/treatment
Hip Fractures Procedure: Fractures were treated with a Gamma 3 intramedullary nail Procedure: Fractures were treated with a Gamma 3 intramedullary nail + U-Blade

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Study Type : Observational
Actual Enrollment : 135 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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?
Study Start Date : January 2009
Actual Primary Completion Date : January 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Cutout rate [ Time Frame: 3 months after intervention ]
    Differences in the Cutout rate of the femoral head screw with/without U-Blade antirational screw


Secondary Outcome Measures :
  1. Mobility [ Time Frame: 3 months after intervention ]
    Mobility of the patients 3 months after intervention measured with the Parker mobility score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

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Responsible Party: Julian Joestl, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02657902     History of Changes
Other Study ID Numbers: 1960/2015
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries