Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures

Not Applicable

Completed

• Conditions: Fractures
• Interventions: Device: Gamma Nail 3; Device: PFNA

• Registration Number: NCT02074969
• Lead Sponsor: Medical University of Vienna

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2010-12
• Study Completion: 2012-05
• Status Verified: 2014-02
• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-02-28
• Last Update Submitted: 2014-02-28
• Study First Posted: 2014-03-03
• Last Update Posted: 2014-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gamma Nail 3	Gamma Nail 3	Gamma Nail 3 Stryker.
PFNA	PFNA	PFNA Antirotation Synthes

Primary Outcome Measures

Name	Time	Method
re-operation rate	time between intervention and one year after

Secondary Outcome Measures

Name	Time	Method
Screw-Cut Out	time between intervention and one year after	evaluation of sliding movements of the hip screw in the sense of a cut-out

Trial Locations

Locations (1)

Department of Trauma, Medical University of Vienna; 🇦🇹 Vienna, Austria