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OpenTrials
Completed

NCT Number: NCT02657902

Does an Additional Antirotation U-Blade (RC) Lagscrew Improve Treatment of AO/OTA (Orthopaedic Trauma Association) 31 A1-3 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fractures were treated with a Gamma 3 intramedullary nail

Procedure

Fractures were treated with a Gamma 3 intramedullary nail + U-Blade

Procedure

Primary outcomes

  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 outcomes

  1. Mobility

    Time frame: 3 months after intervention

    Mobility of the patients 3 months after intervention measured with the Parker mobility score

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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?

Important dates

Study start
2009
Primary completion
2015
First posted
Jan 18, 2016
Registry last updated
Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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