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Completed

NCT Number: NCT02074969

Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures

The purpose of this study is to assess the differences between two different types of devices for the treatment of unstable pertrochanteric hip fractures. The hypothesis of this study is, that patients who are treated with the proximal femoral Nail Antirotation (PFNA) have a better outcome and lower complication rates than patients treated with the Gamma Nail (GN3).

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Key information

Conditions

Fractures Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Trauma, Medical University of Vienna

Vienna, Austria, 1090

About this study

This trial is a prospective randomized controlled study including the treatment of AO/OTA 31-A2 fractures in 200 patients with 2 different surgical devices. 100 patients are treated with a Gamma Nail 3 (GN3) (Stryker) the other 100 patients with a Proximal Femoral Nail Antirotation (PFNA) (Synthes).

All surgeries are performed by trauma surgeons at a Level 1 University Hospital. One hundred patients are randomized to the gamma nail and 100 are randomized to the proximal femoral nail for treatment fixation. A 1:1 randomization is performed using sealed envelopes (200 in total), which are opened by the surgeon immediately before the operation.

Patients missing an informed consent form, incomplete chart, or showing a pathologic fracture are getting excluded from final comparisons.

Patients anthropometric data as well as pre-injury mobility assessments, and ASA will be documented. Furthermore the time from admission to going to surgery, surgery length, length of stay and mobility assessment at dischargement are recorded.

After surgery the stay in the hospital is documented precisely and patients are scheduled for next appointments 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery.

Postoperative X-rays are measured precisely to determine the Tip-Apex Distance (TAD), the Parkers-Ratio, the Singh-Score and the Neck-Shaft-Angle of the injured and contralateral side. Rates of complications as cut-out and reoperation-rates are evaluated. All intra-operative complications are noted and included in the chart.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • AO/OTA 31-A2 fractures
  • age between 18 - 100 years
  • Signed written informed consent and agreement to attend the planned FUs
  • Able to understand and read country national language at an elementary level

Exclusion criteria

  • missing informed consent form
  • pathological fracture
  • incomplete patient record
  • death within one month of intervention (surgery)
  • prior surgery to the hip
  • polytrauma
  • any additional fracture
  • any implant at the same hip
  • infection

Treatment and study plan

Gamma Nail 3

Device

Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by Gamma Nail 3.

Other names: Gamma Nail 3 Stryker

PFNA

Device

Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by PFNA.

Other names: PFNA Antirotation Synthes

Primary outcomes

  1. re-operation rate

    Time frame: time between intervention and one year after

Secondary outcomes

  1. Screw-Cut Out

    Time frame: time between intervention and one year after

    evaluation of sliding movements of the hip screw in the sense of a cut-out

Other outcomes

  1. Mobility assessment

    Time frame: time between hospitalization and one year after intervention

    Mobility assessment includes scoring of pre-operative level of mobility and mobility after intervention

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures - Epidemiological Data and Rates of Complications

Important dates

Study start
2007
Primary completion
2010
Study completion
2012
First posted
Mar 3, 2014
Registry last updated
Mar 3, 2014

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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