Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures
1 other identifier
interventional
200
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 27, 2014
CompletedFirst Posted
Study publicly available on registry
March 3, 2014
CompletedMarch 3, 2014
February 1, 2014
3.2 years
February 27, 2014
February 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
re-operation rate
time between intervention and one year after
Secondary Outcomes (1)
Screw-Cut Out
time between intervention and one year after
Other Outcomes (1)
Mobility assessment
time between hospitalization and one year after intervention
Study Arms (2)
Gamma Nail 3
ACTIVE COMPARATORGamma Nail 3 Stryker.
PFNA
ACTIVE COMPARATORPFNA Antirotation Synthes
Interventions
Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by Gamma Nail 3.
Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by PFNA.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Trauma, Medical University of Vienna
Vienna, Austria, 1090, Austria
Related 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 Joint Surg Am. 2010 Apr;92(4):792-8. doi: 10.2106/JBJS.I.00508.
PMID: 20360500RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harald K. Widhalm, M.D.
Department of Trauma, Medical University of Vienna, Austria
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
February 27, 2014
First Posted
March 3, 2014
Study Start
October 1, 2007
Primary Completion
December 1, 2010
Study Completion
May 1, 2012
Last Updated
March 3, 2014
Record last verified: 2014-02