Back to resultsPFN-A Augmentation for Intertrochanteric Femoral Fractures
Primary Purpose
Intertrochanteric Fracture
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cement augmentation
PFN-A Nail
Sponsored by
About this trial
This is an interventional treatment trial for Intertrochanteric Fracture focused on measuring Augmentation, PET-CT, Positron Emission Tomography, Fluorine-18
Eligibility Criteria
Inclusion Criteria:
- Intertrochanteric Hip Fracture AO (Arbeitsgemeinschaft für Osteosynthesefragen) 31-A1 or AO 31-A2
- Healthy contralateral hip
- ASA (American Society of Anesthesiologists) Physical Status Class I or II
Exclusion Criteria:
- Dementia
Sites / Locations
- Uppsala University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Nail
Augmented Nail
Arm Description
Hip fracture surgery with a PFN-A Nail (Proximal Femoral Nail Augmentation).
Hip fracture surgery with a PFN-A Nail with Cement augmentation with TraumaCemV+
Outcomes
Primary Outcome Measures
Viability of the femoral head as assessed by fluoride uptake using PET-CT
The primary endpoint is the level of fluoride uptake (standardized uptake values: SUVs) representing bone metabolism. PET-CT enables us to quantify this tridimensionally.
Secondary Outcome Measures
Viability of the femoral head as assessed by fluoride uptake using PET-CT
Viability of the femoral head as assessed by fluoride uptake using PET-CT
Harris Hip Score
Harris Hip Score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03000972
Brief Title
PFN-A Augmentation for Intertrochanteric Femoral Fractures
Official Title
PFN-A Intramedullary Nail and Intertrochanteric Hip Fracture. Augmentation of the Femoral Head Assessed by PET-CT (Positron Emission Tomography - Computed Tomography)- a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the potential negative effect of cement augmentation in the femoral head on viability of the head. Half of the participants will have the standard intramedullary nail (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail plus cement augmentation.
Detailed Description
Cement augmentation is believed to increase the bone implant interface and therefore decrease the risk of implant cut-out of the femoral head. The cement used in previous studies has produced heat and thermal necrosis on bone cells. The cement used in this study (TraumaCemV+) is manufactured specially for this implant and for the augmentation of this implant. TraumaCemV sets under low temperature (40 degrees Celsius) and we do not anticipate any heat necrosis. The volume effect of the cement could theoretically also damage the blood flow in the femoral head. There have been no negative effects in big series of patients operated with this technique.
The aim of this study is to quantify the viability of the femoral head with the use PET-CT (Positron Emission Tomography with simultaneous Computed Tomography) including a radioactive isotope (Fluorine-18) and the use of threedimensional computed tomography.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intertrochanteric Fracture
Keywords
Augmentation, PET-CT, Positron Emission Tomography, Fluorine-18
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Nail
Arm Type
Active Comparator
Arm Description
Hip fracture surgery with a PFN-A Nail (Proximal Femoral Nail Augmentation).
Arm Title
Augmented Nail
Arm Type
Experimental
Arm Description
Hip fracture surgery with a PFN-A Nail with Cement augmentation with TraumaCemV+
Intervention Type
Procedure
Intervention Name(s)
Cement augmentation
Intervention Type
Procedure
Intervention Name(s)
PFN-A Nail
Primary Outcome Measure Information:
Title
Viability of the femoral head as assessed by fluoride uptake using PET-CT
Description
The primary endpoint is the level of fluoride uptake (standardized uptake values: SUVs) representing bone metabolism. PET-CT enables us to quantify this tridimensionally.
Time Frame
4 months postoperatively
Secondary Outcome Measure Information:
Title
Viability of the femoral head as assessed by fluoride uptake using PET-CT
Time Frame
Within 1 week postoperatively
Title
Viability of the femoral head as assessed by fluoride uptake using PET-CT
Time Frame
1 year postoperatively
Title
Harris Hip Score
Time Frame
4 months
Title
Harris Hip Score
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Intertrochanteric Hip Fracture AO (Arbeitsgemeinschaft für Osteosynthesefragen) 31-A1 or AO 31-A2
Healthy contralateral hip
ASA (American Society of Anesthesiologists) Physical Status Class I or II
Exclusion Criteria:
Dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olof Wolf, MD PhD
Organizational Affiliation
Uppsala University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
State/Province
Uppsala Lan
ZIP/Postal Code
75185
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PFN-A Augmentation for Intertrochanteric Femoral Fractures
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