Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

Hip Fractures Clinical Trial

Official title:

Comparison of Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation for the Treatment of Closed Unstable Trochanteric Fractures - A Randomized-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473082
• Other study ID #: PFNA augmented
• Status: Completed
• Phase: Phase 4
• Start date: February 2012
• Est. completion date: January 2016

Study information

• Verified date: July 2018
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether patients with trochanteric fractures being treated with a Proximal Femoral Nail Antirotation (PFNA) and augmentation can better be mobilized than patients without augmentation.

Description:

To avoid the pain-causing relative movement between implant and bone, surgical techniques and devices allowing augmentation of the femoral head have recently been developed. Biomechanical studies showed that augmentation leads to a better axial stability and pull-out strength. In clinical practice, this might facilitate early mobilization and full weight-bearing with less pain. The purpose of this study is therefore to evaluate whether patients with trochanteric fractures being treated with a PFNA and augmentation can better be mobilized than patients without augmentation. In particular, it will be measured whether patients with a PFNA Augmentation can walk faster than the non-augmented patients, measured with the Timed up and Go test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Age 75 years and older

• Closed unstable trochanteric fracture: AO 31 - A2 and A3

• Low energy trauma (e.g.fall from standing height)

• Definitive fracture fixation within 72 hrs. after admission

• Indication for PFNA fixation (with or without augmentation)

• Ability to walk independently (walking aids are allowed) prior to injury

• Signed written informed consent and agreement to attend the planned FUs

• Able to understand and read country national language at an elementary level

Exclusion Criteria:

• Pathologic fracture

• Polytrauma

• Any additional fracture

• Open fracture

• Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment

• Active malignancy defined as history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and symptoms for at least five years

• ASA class V and VI

• Any implant at the same hip

• Hemiplegia

• Patients with legal guardian

• Patients who have participated in any other device or drug related clinical trial that could influence the results of the present study within the previous month

• Fractures and injuries opening into the articulation and vascular structure

• Infection

• Patients with clotting disorders

• Patients with severe cardiac and / or pulmonary insufficiency

• Patients with known hypersensitivity or allergy to any of the components of Traumacem V+ cement (Polymethyl methacrylate / acrylate, zirconium dioxide, hydroxyapatite,benzoyl peroxide, methyl methacrylate,hydroquinone, N,N-dimethyl-p-toluidine)

• Perforation of the femoral head into the joint with the guide wire used for the PFNA blade

• Risk of potential leakage into the joint identified by using contrast fluid (PFNA Augmentation group only)

• Intraoperative decision to use implants other than PFNA

Related Conditions & MeSH terms

• Closed Fracture of Hip
• Fractures, Bone
• Fractures, Closed
• Hip Fractures

Intervention

Device:
• PFNA Augmentation (Synthes)
Proximal Femoral Nail Antirotation (PFNA) Augmentation (with Traumacem V+)
• PFNA (Synthes)
Proximal Femoral Nail Antirotation (PFNA)

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck	Innsbruck
Belgium	KUL Univ. Ziekenhuizen Leuven	Leuven
Germany	BGU Tübingen	Tübingen
Germany	University of Ulm	Ulm
Germany	Sophien und Hufeland Klinikum GmbH	Weimar
Israel	Hadassah Medical Organization	Jerusalem
Norway	Sykehuset i Vestfold HF Tønsberg	Tønsberg
Switzerland	Cantonal Hospital Lucerne	Lucerne
Switzerland	City Hospital Waid	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Israel,  Norway,  Switzerland, 

References & Publications (1)

Kammerlander C, Hem ES, Klopfer T, Gebhard F, Sermon A, Dietrich M, Bach O, Weil Y, Babst R, Blauth M. Cement augmentation of the Proximal Femoral Nail Antirotation (PFNA) - A multicentre randomized controlled trial. Injury. 2018 Aug;49(8):1436-1444. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobility measured with the "timed up & go"-test during hospital stay.	The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seat position is reached again. Patient-perceived pain and exertion will be assessed after the test.	5 to 7 days postoperative
Secondary	Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only).		Intraoperative
Secondary	Pain	Pain, measured with the Numerical Rating Scale (NRS) and use of pain medication postoperative.	one year
Secondary	Duration of hospital stay		one year
Secondary	Walking ability	Parker Mobility Score	one year
Secondary	Return to pre-fracture residential status		one year
Secondary	Timed up & go-test at follow-ups	The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seat position is reached again.	one year
Secondary	Quality of life	EuroQol-5D	one year
Secondary	Local adverse events and revision rate	Implant / surgery, bone / fracture, soft tissue of the musculoskeletal system, wound related adverse events	one year
Secondary	Systemic adverse events		one year
Secondary	Implant migration	Measured at the CT in a subgroup only	one year
Secondary	Mortality		one year
Secondary	Fracture risk prior to injury	Measured with the Fracture Risk Assessment Tool (FRAX)	1 week prior to operation
Secondary	Functional independence	Measured with the Barthel Index	1 week prior to operation
Secondary	Comorbidity	Charlson Comorbidiy Index	1 week prior to operation