Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures

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

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).

Study Overview

• Status: Completed
• Conditions: Fractures
• Intervention / Treatment: Device: Gamma Nail 3; Device: PFNA

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Trauma, Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gamma Nail 3; Gamma Nail 3 Stryker.	Device: Gamma Nail 3; Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by Gamma Nail 3.; Other Names: Gamma Nail 3 Stryker
Active Comparator: PFNA; PFNA Antirotation Synthes	Device: PFNA; Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by PFNA.; Other Names: PFNA Antirotation Synthes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
re-operation rate	time between intervention and one year after

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobility assessment	Mobility assessment includes scoring of pre-operative level of mobility and mobility after intervention	time between hospitalization and one year after intervention

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Harald K. Widhalm, M.D., Department of Trauma, Medical University of Vienna, Austria

Publications and helpful links

General Publications

• Barton TM, Gleeson R, Topliss C, Greenwood R, Harries WJ, Chesser TJ. A comparison of the long gamma nail with the sliding hip screw for the treatment of AO/OTA 31-A2 fractures of the proximal part of the femur: a prospective randomized trial. J Bone Joint Surg Am. 2010 Apr;92(4):792-8. doi: 10.2106/JBJS.I.00508.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: February 27, 2014
• First Submitted That Met QC Criteria: February 28, 2014
• First Posted (Estimate): March 3, 2014

Study Record Updates

• Last Update Posted (Estimate): March 3, 2014
• Last Update Submitted That Met QC Criteria: February 28, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: pertrochanteric fractures; re-operation rate; GammaNail; PFNA; Tip-Apex-Distance; Parkers-Ratio
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 2007406