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Pertrochanteric Fracture Fixation In Elderly Adults Using Proximal Femoral Nail Anti-rotation (HERACLES) With a T-shaped Parallel Blade: A New Design (Heracles PFN)

Primary Purpose

Pertrochanteric Fracture, Intertrochanteric Fractures, Pertrochanteric Fracture of Femur, Closed

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Proximal femoral nail with straight parallel blade
Sponsored by
Ilocos Training and Regional Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pertrochanteric Fracture focused on measuring Pertrochanteric fracture, Intertrochanteric fracture, subtrochanteric extension, Proximal femoral nail, Proximal locking screw, Distal locking screw

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients who sustained stable pertrochanteric fracture (AO31A.1)
  2. Patients who sustained unstable pertrochanteric fracture (AO31A.2 or AO31A.)

Exclusion Criteria:

  1. Patients who are bedridden
  2. Patients with a neurologic/psychiatric disorder (previous or present)
  3. Patients with severe dementia/Alzheimer's disease
  4. Patient with a history of hip dislocation (whether reduced or unreduced)
  5. Patient who underwent previous operation on the hip
  6. Patient with amputation of one or both legs
  7. Patient with segmental fractures involving the ipsilateral femoral shaft/metaphysis
  8. Patient with pathologic fractures, e.g. secondary to metastatic bone disease/ metabolic bone disease
  9. Patient presenting with an infection
  10. Patient who sustained multiple injuries from other body systems

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PFN straight parallel blade

    Arm Description

    All patients with pertrochanteric fracture that is eligible will undergo PFNA with straight parallel blade.

    Outcomes

    Primary Outcome Measures

    Time to Clinical Union
    Weeks until Union Clinical Union - fracture site becomes stable and pain-free
    Time to full weightbearing
    weeks until full weight bearing without pain

    Secondary Outcome Measures

    Quality and Maintenance of Reduction
    Acceptable reduction was defined as: Range of neck angle between 5° varus and 20° valgus. <20 deg angulation on lateral No fragment greater than 4 mm displaced Reduction is defined as good (3/3), adequate (2/3) and poor (0-1/3)
    Tip-Apex Distance
    expressed in millimetres, is the sum of the distance from the tip of the blade to the apex of the femoral head on both AP and lateral radiographic views
    Blood Loss
    Blood loss during the procedure in milliliters
    Fluoroscopy time
    Total time of exposure during the procedure starting from identification of starting point to insertion of distal locking screw
    Mobility scale
    Mobility scoring modified for use in patients who sustained a hip fracture (Bowers and Parker 2016). 1 is best and 10 is worst. Never uses any walking aid, no restriction in walking distance Never uses any walking aid, can walk less than one kilometer Occasionally uses a walking aid Normally uses one walking stick or needs to hold on to furniture Normally uses two sticks or crutches Mobilizes with a frame alone, without the need for assistance Mobilizes with a frame and the assistance of one other person Mobilizes with a frame and the assistance of two people Bed-to-chair, or wheelchair-bound Bedbound most or all of the day.
    Social dependence scale
    Modified to apply for hip fractures; includes determination of independence to ADLs and advanced ADLs (Bowers and Parker 2016) 1 is best and 8 is worst Completely independent Minimal assistance Moderate assistance Regular assistance Dependent Severely dependent Fully dependent Patient temporarily resident in hospital
    Pain scale
    Pain scale adapted for hip fractures (Bowers and Parker 2016) 1 is best and 8 is worst 0. Unable to answer No pain at all in the hip Occasional and slight pain Some pain when starting to walk, no rest pain. None or minimal pain at rest, some pain with activities Regular pain with activities which limits walking distance. Frequent rest pain and pain at night. Pain on walking. Constant pain presents around the hip. Constant and severe pain in the hip requires regular strong analgesia such as opiates.
    Radiographic Union Score for the Hip
    is a validated outcome instrument designed to improve intra and interobserver reliability when describing the radiographic healing of proximal femur fractures Based on grading of the anterior cortex, posterior cortex, lateral cortex and medial cortex bridging - No cortical bridging - Some cortical bridging - Complete Cortical Bridging In addition, disappearance of the fracture line in the anterior cortex, posterior cortex, medial cortex, lateral cortex - Fully visible fracture line - Some evidence of the fracture line - No evidence of fracture line Add all component scores to get the total score
    Radiation load
    Amount of radiation during the procedure as measured by a Dosimeter

    Full Information

    First Posted
    April 6, 2019
    Last Updated
    April 9, 2019
    Sponsor
    Ilocos Training and Regional Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03911180
    Brief Title
    Pertrochanteric Fracture Fixation In Elderly Adults Using Proximal Femoral Nail Anti-rotation (HERACLES) With a T-shaped Parallel Blade: A New Design
    Acronym
    Heracles PFN
    Official Title
    Pertrochanteric Fracture Fixation In Elderly Adults Using Proximal Femoral Nail Anti-rotation (HERACLES) With a T-shaped Parallel Blade: A New Design
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2019 (Anticipated)
    Primary Completion Date
    May 1, 2020 (Anticipated)
    Study Completion Date
    May 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ilocos Training and Regional Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a prospective case series of elderly adult patients sustaining pertrochanteric fractures who will be treated by a proximal femoral nail with a non-helical (straight) blade. This study seeks to observe and evaluate the outcomes, advantages and complication rates in using the HERACLES PFN with a non-helical (T-shaped parallel) blade.
    Detailed Description
    The trochanteric area is defined by AO as the area bordered by the tip of the greater trochanter, extracapsular portion of the femoral neck extending to a line parallel to the inferior most border of the lesser trochanter. Pertrochanteric fracture is a fracture is of the trochanteric area which is usually reducible. Unstable pertrochanteric fracture is defined as AO-31A2 or AO-31A3. Instability arises from the degree of comminution, the presence, and comminution of the posteromedial fragment and lastly, lateral wall involvement The ideal implant for fixation of this kind of fractures is still under debate, but intramedullary implants are preferred than extramedullary implants in these unstable fractures. On the other hand, unique fracture configurations predispose to instability such as reverse obliquity fractures and fractures extending to the subtrochanteric area. Proximal femoral locking plate as used in unstable pertrochanteric fracture has a high complication rate. In one study in 2014, there is up to 41.4% failure rate due to the proud plate, screw malposition, too rigid construct when used as a bridge plate. Intramedullary implants specifically cephalomedullary nails has been the mainstay of treatment in unstable pertrochanteric fractures primarily because of the short moment arm and load-sharing properties. It employs relative stability and can be applied in a minimally invasive manner. In 1997, the AO/ASIF group developed the proximal femoral nail. The proximal femoral nail has two proximal screws that traverse the neck to the femoral head. The inferior screw is the load-bearing screw, and the superior screw is the anti-rotation screw. Good to excellent results were observed using this implant compared to previous implant designs, but complications still exist. These complications are related to the position of the two screws. There is difficulty attaining the ideal placement of proximal locking screws. As a result, the early medial cutout of one screw and lateral migration of the second screw occurs which is the so-called Z-effect. To address these disadvantages, the AO/ASIF group in 2004 developed a new implant design wherein the two proximal locking screws are replaced by a single helical blade. This improvement in design maximizes bone purchase and bone contact in cancellous bone hereby improving cutout rates. Even with the new PFNA implant is not exempted from complications. Zhou and Chang in 2012 identified 12 cases of helical blade protrusion in 6 papers. Biomechanically, the helical blade migrates axially through the porotic bone in the geriatric population. The new design of the blade includes a T-shaped anchor for stable fixation in osteoporotic bone. The nail also features a flat lateral design with a smooth radius transition from proximal to distal portion of the nail compared to the bulky profile of conventional nail resulting in easier insertion. Locking mechanism inherent to the nail and blade limits gliding and rotation of the blade. One of the advantages of the system is the use of a radiolucent arm with targeting options for an anti-rotation pin and determination of the superior most aspect of the femoral head for reference. This case-series introduces a modification in implant design of the PFNA and aims to observe outcomes, advantages, and complications related to its use.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pertrochanteric Fracture, Intertrochanteric Fractures, Pertrochanteric Fracture of Femur, Closed, Pertrochanteric Fracture of Femur, Open
    Keywords
    Pertrochanteric fracture, Intertrochanteric fracture, subtrochanteric extension, Proximal femoral nail, Proximal locking screw, Distal locking screw

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PFN straight parallel blade
    Arm Type
    Experimental
    Arm Description
    All patients with pertrochanteric fracture that is eligible will undergo PFNA with straight parallel blade.
    Intervention Type
    Device
    Intervention Name(s)
    Proximal femoral nail with straight parallel blade
    Other Intervention Name(s)
    Heracles proximal femoral nail
    Intervention Description
    Petrochanteric fixation with Heracles proximal femoral nail
    Primary Outcome Measure Information:
    Title
    Time to Clinical Union
    Description
    Weeks until Union Clinical Union - fracture site becomes stable and pain-free
    Time Frame
    2 months to 4 months
    Title
    Time to full weightbearing
    Description
    weeks until full weight bearing without pain
    Time Frame
    4-6 months
    Secondary Outcome Measure Information:
    Title
    Quality and Maintenance of Reduction
    Description
    Acceptable reduction was defined as: Range of neck angle between 5° varus and 20° valgus. <20 deg angulation on lateral No fragment greater than 4 mm displaced Reduction is defined as good (3/3), adequate (2/3) and poor (0-1/3)
    Time Frame
    up to 2 years
    Title
    Tip-Apex Distance
    Description
    expressed in millimetres, is the sum of the distance from the tip of the blade to the apex of the femoral head on both AP and lateral radiographic views
    Time Frame
    up to 2 years
    Title
    Blood Loss
    Description
    Blood loss during the procedure in milliliters
    Time Frame
    Taken immediately postop
    Title
    Fluoroscopy time
    Description
    Total time of exposure during the procedure starting from identification of starting point to insertion of distal locking screw
    Time Frame
    Intraoperative measurement
    Title
    Mobility scale
    Description
    Mobility scoring modified for use in patients who sustained a hip fracture (Bowers and Parker 2016). 1 is best and 10 is worst. Never uses any walking aid, no restriction in walking distance Never uses any walking aid, can walk less than one kilometer Occasionally uses a walking aid Normally uses one walking stick or needs to hold on to furniture Normally uses two sticks or crutches Mobilizes with a frame alone, without the need for assistance Mobilizes with a frame and the assistance of one other person Mobilizes with a frame and the assistance of two people Bed-to-chair, or wheelchair-bound Bedbound most or all of the day.
    Time Frame
    up to 2 years
    Title
    Social dependence scale
    Description
    Modified to apply for hip fractures; includes determination of independence to ADLs and advanced ADLs (Bowers and Parker 2016) 1 is best and 8 is worst Completely independent Minimal assistance Moderate assistance Regular assistance Dependent Severely dependent Fully dependent Patient temporarily resident in hospital
    Time Frame
    up to 2 years
    Title
    Pain scale
    Description
    Pain scale adapted for hip fractures (Bowers and Parker 2016) 1 is best and 8 is worst 0. Unable to answer No pain at all in the hip Occasional and slight pain Some pain when starting to walk, no rest pain. None or minimal pain at rest, some pain with activities Regular pain with activities which limits walking distance. Frequent rest pain and pain at night. Pain on walking. Constant pain presents around the hip. Constant and severe pain in the hip requires regular strong analgesia such as opiates.
    Time Frame
    Postop up to 2 years
    Title
    Radiographic Union Score for the Hip
    Description
    is a validated outcome instrument designed to improve intra and interobserver reliability when describing the radiographic healing of proximal femur fractures Based on grading of the anterior cortex, posterior cortex, lateral cortex and medial cortex bridging - No cortical bridging - Some cortical bridging - Complete Cortical Bridging In addition, disappearance of the fracture line in the anterior cortex, posterior cortex, medial cortex, lateral cortex - Fully visible fracture line - Some evidence of the fracture line - No evidence of fracture line Add all component scores to get the total score
    Time Frame
    up to 2 years
    Title
    Radiation load
    Description
    Amount of radiation during the procedure as measured by a Dosimeter
    Time Frame
    Intraoperative measurement
    Other Pre-specified Outcome Measures:
    Title
    Complications
    Description
    Intraoperative and Postoperative complications. Will describe presence of complications and description of the specific complications. Intraoperative complications involve redisplacement, iatrogenic fracture and comminution, broken implants (drill bit); These include Infection (superficial or deep); Osteomyelitis; Nonunion; Implant failure; Varus collapse and Others Complications will be described in detail to ascertain its causality and recommend how it could have been prevented.
    Time Frame
    Intraoperative to postoperative up to 2 years
    Title
    Technical difficulties
    Description
    Technical difficulties encountered during each component step of the OR These include difficulty in finding the entry point; difficulty inserting the awl; difficulty putting in the guidewire; Wrong entry point; difficulty finding proximal blade insertion and application; difficulty with distal locking screw determination and insertion Any technical difficulty will be described in detail to ascertain the nature and cause of the difficulty (technique dependent vs implant dependent).
    Time Frame
    Intraoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who sustained stable pertrochanteric fracture (AO31A.1) Patients who sustained unstable pertrochanteric fracture (AO31A.2 or AO31A.) Exclusion Criteria: Patients who are bedridden Patients with a neurologic/psychiatric disorder (previous or present) Patients with severe dementia/Alzheimer's disease Patient with a history of hip dislocation (whether reduced or unreduced) Patient who underwent previous operation on the hip Patient with amputation of one or both legs Patient with segmental fractures involving the ipsilateral femoral shaft/metaphysis Patient with pathologic fractures, e.g. secondary to metastatic bone disease/ metabolic bone disease Patient presenting with an infection Patient who sustained multiple injuries from other body systems
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lou Mervyn A. Tec, MD
    Phone
    +639158467650
    Email
    loumervyntec@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gualberto Basco, MD
    Phone
    +639173078467
    Email
    gtbasco12md2004@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29256945
    Citation
    Meinberg EG, Agel J, Roberts CS, Karam MD, Kellam JF. Fracture and Dislocation Classification Compendium-2018. J Orthop Trauma. 2018 Jan;32 Suppl 1:S1-S170. doi: 10.1097/BOT.0000000000001063. No abstract available.
    Results Reference
    background
    PubMed Identifier
    25840887
    Citation
    Chang SM, Zhang YQ, Ma Z, Li Q, Dargel J, Eysel P. Fracture reduction with positive medial cortical support: a key element in stability reconstruction for the unstable pertrochanteric hip fractures. Arch Orthop Trauma Surg. 2015 Jun;135(6):811-8. doi: 10.1007/s00402-015-2206-x. Epub 2015 Apr 4.
    Results Reference
    background
    PubMed Identifier
    17332094
    Citation
    Palm H, Jacobsen S, Sonne-Holm S, Gebuhr P; Hip Fracture Study Group. Integrity of the lateral femoral wall in intertrochanteric hip fractures: an important predictor of a reoperation. J Bone Joint Surg Am. 2007 Mar;89(3):470-5. doi: 10.2106/JBJS.F.00679.
    Results Reference
    background
    PubMed Identifier
    25458060
    Citation
    Sharma G, kumar G N K, Yadav S, Lakhotia D, Singh R, Gamanagatti S, Sharma V. Pertrochanteric fractures (AO/OTA 31-A1 and A2) not amenable to closed reduction: causes of irreducibility. Injury. 2014 Dec;45(12):1950-7. doi: 10.1016/j.injury.2014.10.007.
    Results Reference
    background
    PubMed Identifier
    16496147
    Citation
    Jones HW, Johnston P, Parker M. Are short femoral nails superior to the sliding hip screw? A meta-analysis of 24 studies involving 3,279 fractures. Int Orthop. 2006 Apr;30(2):69-78. doi: 10.1007/s00264-005-0028-0. Epub 2006 Feb 22.
    Results Reference
    background
    PubMed Identifier
    24751607
    Citation
    Johnson B, Stevenson J, Chamma R, Patel A, Rhee SJ, Lever C, Starks I, Roberts PJ. Short-term follow-up of pertrochanteric fractures treated using the proximal femoral locking plate. J Orthop Trauma. 2014 May;28(5):283-7. doi: 10.1097/01.bot.0000435629.86640.6f.
    Results Reference
    background
    PubMed Identifier
    29649099
    Citation
    Radaideh AM, Qudah HA, Audat ZA, Jahmani RA, Yousef IR, Saleh AAA. Functional and Radiological Results of Proximal Femoral Nail Antirotation (PFNA) Osteosynthesis in the Treatment of Unstable Pertrochanteric Fractures. J Clin Med. 2018 Apr 12;7(4):78. doi: 10.3390/jcm7040078.
    Results Reference
    background
    PubMed Identifier
    12095718
    Citation
    Al-yassari G, Langstaff RJ, Jones JW, Al-Lami M. The AO/ASIF proximal femoral nail (PFN) for the treatment of unstable trochanteric femoral fracture. Injury. 2002 Jun;33(5):395-9. doi: 10.1016/s0020-1383(02)00008-6.
    Results Reference
    background
    PubMed Identifier
    10505125
    Citation
    Simmermacher RK, Bosch AM, Van der Werken C. The AO/ASIF-proximal femoral nail (PFN): a new device for the treatment of unstable proximal femoral fractures. Injury. 1999 Jun;30(5):327-32. doi: 10.1016/s0020-1383(99)00091-1.
    Results Reference
    background
    PubMed Identifier
    21818023
    Citation
    Gardenbroek TJ, Segers MJ, Simmermacher RK, Hammacher ER. The proximal femur nail antirotation: an identifiable improvement in the treatment of unstable pertrochanteric fractures? J Trauma. 2011 Jul;71(1):169-74. doi: 10.1097/TA.0b013e3182213c6e.
    Results Reference
    background
    PubMed Identifier
    22079147
    Citation
    Zhou JQ, Chang SM. Failure of PFNA: helical blade perforation and tip-apex distance. Injury. 2012 Jul;43(7):1227-8. doi: 10.1016/j.injury.2011.10.024. Epub 2011 Nov 12. No abstract available.
    Results Reference
    background

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    Pertrochanteric Fracture Fixation In Elderly Adults Using Proximal Femoral Nail Anti-rotation (HERACLES) With a T-shaped Parallel Blade: A New Design

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