Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures
Primary Purpose
Fractures
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Gamma Nail 3
PFNA
Sponsored by
About this trial
This is an interventional treatment trial for Fractures focused on measuring re-operation rate, pertrochanteric fractures, GammaNail, PFNA, Tip-Apex-Distance, Parkers-Ratio
Eligibility Criteria
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
Sites / Locations
- Department of Trauma, Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Gamma Nail 3
PFNA
Arm Description
Gamma Nail 3 Stryker.
PFNA Antirotation Synthes
Outcomes
Primary Outcome Measures
re-operation rate
Secondary Outcome Measures
Screw-Cut Out
evaluation of sliding movements of the hip screw in the sense of a cut-out
Full Information
NCT ID
NCT02074969
First Posted
February 27, 2014
Last Updated
February 28, 2014
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT02074969
Brief Title
Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures
Official Title
Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures - Epidemiological Data and Rates of Complications
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures
Keywords
re-operation rate, pertrochanteric fractures, GammaNail, PFNA, Tip-Apex-Distance, Parkers-Ratio
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gamma Nail 3
Arm Type
Active Comparator
Arm Description
Gamma Nail 3 Stryker.
Arm Title
PFNA
Arm Type
Active Comparator
Arm Description
PFNA Antirotation Synthes
Intervention Type
Device
Intervention Name(s)
Gamma Nail 3
Other Intervention Name(s)
Gamma Nail 3 Stryker
Intervention Description
Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by Gamma Nail 3.
Intervention Type
Device
Intervention Name(s)
PFNA
Other Intervention Name(s)
PFNA Antirotation Synthes
Intervention Description
Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by PFNA.
Primary Outcome Measure Information:
Title
re-operation rate
Time Frame
time between intervention and one year after
Secondary Outcome Measure Information:
Title
Screw-Cut Out
Description
evaluation of sliding movements of the hip screw in the sense of a cut-out
Time Frame
time between intervention and one year after
Other Pre-specified Outcome Measures:
Title
Mobility assessment
Description
Mobility assessment includes scoring of pre-operative level of mobility and mobility after intervention
Time Frame
time between hospitalization and one year after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harald K. Widhalm, M.D.
Organizational Affiliation
Department of Trauma, Medical University of Vienna, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Trauma, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
20360500
Citation
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.
Results Reference
result
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Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures
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