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
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
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
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
NCT ID
NCT03911180
First Posted
April 6, 2019
Last Updated
April 9, 2019
Sponsor
Ilocos Training and Regional Medical Center
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
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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
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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
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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
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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
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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
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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
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PubMed Identifier
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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
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PubMed Identifier
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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
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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
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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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