NCT03911180

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

April 11, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

April 6, 2019

Last Update Submit

April 9, 2019

Conditions

Pertrochanteric FractureIntertrochanteric FracturesPertrochanteric Fracture of Femur, ClosedPertrochanteric Fracture of Femur, Open

Keywords

Pertrochanteric fractureIntertrochanteric fracturesubtrochanteric extensionProximal femoral nailProximal locking screwDistal locking screw

Outcome Measures

Primary Outcomes (2)

  • Time to Clinical Union

    Weeks until Union Clinical Union - fracture site becomes stable and pain-free

    2 months to 4 months

  • Time to full weightbearing

    weeks until full weight bearing without pain

    4-6 months

Secondary Outcomes (9)

  • Quality and Maintenance of Reduction

    up to 2 years

  • Tip-Apex Distance

    up to 2 years

  • Blood Loss

    Taken immediately postop

  • Fluoroscopy time

    Intraoperative measurement

  • Mobility scale

    up to 2 years

  • +4 more secondary outcomes

Other Outcomes (2)

  • Complications

    Intraoperative to postoperative up to 2 years

  • Technical difficulties

    Intraoperative

Study Arms (1)

PFN straight parallel blade

EXPERIMENTAL

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

Device: Proximal femoral nail with straight parallel blade

Interventions

Proximal femoral nail with straight parallel bladeDEVICE

Petrochanteric fixation with Heracles proximal femoral nail

Also known as: Heracles proximal femoral nail
PFN straight parallel blade

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 29256945BACKGROUND

  • 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.

    PMID: 25840887BACKGROUND

  • 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.

    PMID: 17332094BACKGROUND

  • 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.

    PMID: 25458060BACKGROUND

  • 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.

    PMID: 16496147BACKGROUND

  • 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.

    PMID: 24751607BACKGROUND

  • 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.

    PMID: 29649099BACKGROUND

  • 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.

    PMID: 12095718BACKGROUND

  • 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.

    PMID: 10505125BACKGROUND

  • 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.

    PMID: 21818023BACKGROUND

  • 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.

    PMID: 22079147BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Central Study Contacts

Lou Mervyn A. Tec, MD

CONTACT

+639158467650loumervyntec@gmail.com

Gualberto Basco, MD

CONTACT

+639173078467gtbasco12md2004@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Resident Year Level IV

Study Record Dates

First Submitted

April 6, 2019

First Posted

April 11, 2019

Study Start

May 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2022

Last Updated

April 11, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share