search
Back to results

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
Princess Alexandra Hospital, Brisbane, Australia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Fractured Neck of Femur

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 10, 2017
    Last Updated
    February 26, 2019
    Sponsor
    Princess Alexandra Hospital, Brisbane, Australia
    search

    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

    We'll reach out to this number within 24 hrs