- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03911180
Pertrochanteric Fracture Fixation In Elderly Adults Using Proximal Femoral Nail Anti-rotation (HERACLES) With a T-shaped Parallel Blade: A New Design (Heracles PFN)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lou Mervyn A. Tec, MD
- Phone Number: +639158467650
- Email: loumervyntec@gmail.com
Study Contact Backup
- Name: Gualberto Basco, MD
- Phone Number: +639173078467
- Email: gtbasco12md2004@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PFN straight parallel blade
All patients with pertrochanteric fracture that is eligible will undergo PFNA with straight parallel blade.
|
Petrochanteric fixation with Heracles proximal femoral nail
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Clinical Union
Time Frame: 2 months to 4 months
|
Weeks until Union Clinical Union - fracture site becomes stable and pain-free |
2 months to 4 months
|
Time to full weightbearing
Time Frame: 4-6 months
|
weeks until full weight bearing without pain
|
4-6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality and Maintenance of Reduction
Time Frame: up to 2 years
|
Acceptable reduction was defined as:
Reduction is defined as good (3/3), adequate (2/3) and poor (0-1/3) |
up to 2 years
|
Tip-Apex Distance
Time Frame: up to 2 years
|
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
|
up to 2 years
|
Blood Loss
Time Frame: Taken immediately postop
|
Blood loss during the procedure in milliliters
|
Taken immediately postop
|
Fluoroscopy time
Time Frame: Intraoperative measurement
|
Total time of exposure during the procedure starting from identification of starting point to insertion of distal locking screw
|
Intraoperative measurement
|
Mobility scale
Time Frame: up to 2 years
|
Mobility scoring modified for use in patients who sustained a hip fracture (Bowers and Parker 2016). 1 is best and 10 is worst.
|
up to 2 years
|
Social dependence scale
Time Frame: up to 2 years
|
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
|
up to 2 years
|
Pain scale
Time Frame: Postop up to 2 years
|
Pain scale adapted for hip fractures (Bowers and Parker 2016) 1 is best and 8 is worst 0. Unable to answer
|
Postop up to 2 years
|
Radiographic Union Score for the Hip
Time Frame: up to 2 years
|
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
In addition, disappearance of the fracture line in the anterior cortex, posterior cortex, medial cortex, lateral cortex
Add all component scores to get the total score |
up to 2 years
|
Radiation load
Time Frame: Intraoperative measurement
|
Amount of radiation during the procedure as measured by a Dosimeter
|
Intraoperative measurement
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications
Time Frame: Intraoperative to postoperative up to 2 years
|
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. |
Intraoperative to postoperative up to 2 years
|
Technical difficulties
Time Frame: Intraoperative
|
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). |
Intraoperative
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITRMCOrthoCS0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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