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

NCT ID: NCT03911180

Last Updated: 2019-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2022-05-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PFN straight parallel blade

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

Group Type: EXPERIMENTAL

Proximal femoral nail with straight parallel blade

Intervention Type: DEVICE

Petrochanteric fixation with Heracles proximal femoral nail

Interventions

Proximal femoral nail with straight parallel blade

Petrochanteric fixation with Heracles proximal femoral nail

Intervention Type: DEVICE

Other Intervention Names

Heracles proximal femoral nail

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ilocos Training and Regional Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Lou Mervyn Tec

Orthopedic Resident Year Level IV

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Lou Mervyn A. Tec, MD

Role: CONTACT

loumervyntec@gmail.com

+639158467650

Gualberto Basco, MD

Role: CONTACT

gtbasco12md2004@yahoo.com

+639173078467

References

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.

Reference Type: BACKGROUND

PMID: 29256945 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25840887 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17332094 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25458060 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16496147 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24751607 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29649099 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12095718 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10505125 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21818023 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22079147 (View on PubMed)

Other Identifiers

ITRMCOrthoCS0001

Identifier Type: -

Identifier Source: org_study_id