10 Year Review of the Experience of the PFNA ,TFNA the Affixus Nail
Primary Purpose
Fractured Neck of Femur
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Intermedullary nail
Sponsored by
About this trial
This is an observational trial for Fractured Neck of Femur
Eligibility Criteria
Inclusion Criteria:
. fractured neck of femur
Exclusion Criteria:
. NOT fractured neck of femur
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Arm Label
Affixus
PFNA
TFNA
Arm Description
To compare Affixus to PFNA and TFNA
To compare PFNA to Affixus and TFNA
To compare TFNA toPFNA and Affixus
Outcomes
Primary Outcome Measures
Reoperation
Taken back to the operating room for reoperation
Secondary Outcome Measures
Failure
Unable to weight bear
Full Information
NCT ID
NCT03493893
First Posted
April 10, 2017
Last Updated
February 26, 2019
Sponsor
Princess Alexandra Hospital, Brisbane, Australia
1. Study Identification
Unique Protocol Identification Number
NCT03493893
Brief Title
10 Year Review of the Experience of the PFNA ,TFNA the Affixus Nail
Official Title
10 Year Review of the Experience of the PFNA ,TFNA the Affixus Nail
Study Type
Observational
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 2006 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Princess Alexandra Hospital, Brisbane, Australia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study was to investigate the clinical effects of design changes from the use of three different IM nail designs in the management of extracapsular hip fractures.
Detailed Description
Intertrochanteric hip fractures are one of the more common orthopaedic presentations, with an approximate incidence in Australia of 230 cases per 100,000 population. The importance of this pathology is well documented being the major fracture-related health care cost and cause of mortality in all sexes over 50 years of age.
Contemporary fixation of the proximal femur is performed utilising a number of implants adopting different concepts and techniques. Cephalomedullary/Intermedullary femoral nails (IM nails) over the last 15 years have gained popularity. IM nails are implanted via a small incision and intermedullary insertion through the greater trochanter, secured by passing a screw or blade through the femoral neck into the femoral head. This nailing technique offers the theoretical benefits of a smaller incision with less tissue dissection and hence reduced blood loss, infection and operating time. As well as a proposed biomechanical advantage due to a shorter lever arm, sharing the load and minimising proximal collapse.
Biomechanical studies of IM nails in the use of extracapsular fractures of the femoral neck have found benefit over existing sliding/compression hip screws (CHS). Advantages have been observed in combined bending and compression performance to failure. As well as postoperative rigidity in unstable subtrochanteric fractures, and load bearing capability. Significantly greater fatigue strength and fatigue life have additionally been shown in cyclic loading assessment and reduced incidence of cut out has been observed, showing benefit over the use of CHS.
Early trials however found a higher rate of operative complications involving IM fixation, including fractures at the tip of the nail or related to distal locking. Following this several studies have compared the clinical outcomes of CHS vs IM nails with varying findings questioning the overall patient benefit, especially in stable fracture patterns. From a review of the past literature the common trend is a longer operative time and higher associated blood loss with CHS, but fewer intraoperative surgical related complications and less fluoroscopic time with the use of nails. IM nail use has shown to offer better post-operative ambulatory function and reduced limb shortening but it appears due to the early complications of this technique numerous variations in implant design have emerged.
Purpose In recent years further development has occurred in nail design in an attempt to reduce the incidence of fixation failure. The aim of this study was to investigate the clinical effects of these design changes from the use of three different IM nail designs in the management of extracapsular hip fractures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractured Neck of Femur
7. Study Design
Enrollment
800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Affixus
Arm Description
To compare Affixus to PFNA and TFNA
Arm Title
PFNA
Arm Description
To compare PFNA to Affixus and TFNA
Arm Title
TFNA
Arm Description
To compare TFNA toPFNA and Affixus
Intervention Type
Device
Intervention Name(s)
Intermedullary nail
Other Intervention Name(s)
Affixus, PFNA, TFNA
Intervention Description
investigate the clinical effects of these design changes from the use of three different IM nail designs in the management of extracapsular hip fractures.
Primary Outcome Measure Information:
Title
Reoperation
Description
Taken back to the operating room for reoperation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Failure
Description
Unable to weight bear
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
. fractured neck of femur
Exclusion Criteria:
. NOT fractured neck of femur
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cameron Cooke
Organizational Affiliation
Princess Alexandra Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
10 Year Review of the Experience of the PFNA ,TFNA the Affixus Nail
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