Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures

Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02074969
• Other study ID #: 2007406
• Status: Completed
• Phase: N/A
• First received: February 27, 2014
• Last updated: February 28, 2014
• Start date: October 2007
• Est. completion date: May 2012

Study information

• Verified date: February 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures
• Fractures, Bone

Intervention

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

Locations

Country	Name	City	State
Austria	Department of Trauma, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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 Join — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mobility assessment	Mobility assessment includes scoring of pre-operative level of mobility and mobility after intervention	time between hospitalization and one year after intervention	Yes
Primary	re-operation rate		time between intervention and one year after	Yes
Secondary	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	Yes