Treatment of Unstable Trochanteric Fractures With the Proximal Femoral Nail - Antirotation (PFNA)-Asia

Treatment of Unstable Trochanteric Fractures With the Proximal Femoral Nail - Antirotation Asia - A Prospective Multicenter Case Series

The primary objective of this prospective multicenter study is to assess any fracture fixation complication and revision rates during the clinical use of the Proximal Femoral Nail Antirotation Asia (PFNA Asia) for the treatment of unstable trochanteric fractures.

Study Overview

• Status: Completed
• Conditions: Trochanteric Fractures
• Intervention / Treatment: Device: PFNA-Asia

Detailed Description

From several studies, e.g. on hip prostheses, it is known that the Asian population has other geometric proportions than Caucasians, e.g. Japanese woman have shorter femoral necks, smaller femoral neck angles and a more anterior bowing of the shaft than white Americans. This was one of the reasons for the development of a new PFNA Asia with adapted sizes and geometry. No controlled clinical data are available whether the rate of mismatch and mismatch-related complications could be reduced.

• Study Type: Observational
• Enrollment (Actual): 245

Contacts and Locations

Study Locations

• Japan
  • Toyama, Japan, 939-8511
    • Toyama Municipal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute trochanteric fractures at surgery/ orthopedic departments

Description

Inclusion Criteria:

• Age 65 years and older
• Patients with isolated, unstable, closed trochanteric fractures, classified as AO 31-A2 or AO 31-A3
• Definitive primary fracture treatment with PFNA Asia within 7 days sustaining the fracture (conversion from an external fixator to the PFNA Asia as an emergency procedure within the first week after the accident is allowed)
• Signed written informed consent (by the subjects or legal guardian) and agreement to attend the planned follow-ups
• Willing and able to comply with the post-operative management program
• Able to understand and read country national language at an elementary level

Exclusion Criteria:

• Pathologic fracture
• Patients or legal guardian refusing to sign the informed consent form
• Patients with previous implants on the fractured hip and femur
• Drug or alcohol abuse
• Active malignancy
• ASA class V and VI
• Patients who are bed-ridden or wheel-chair ridden prior to injury event
• Neurological disorders and psychiatric disorders that would preclude reliable assessment (e.g., Parkinson disease, Multiple sclerosis, severe depression)
• Patients who have participated in any other device or drug related clinical trial within the previous month

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PFNA_Asia treated	Device: PFNA-Asia; The operation is performed under regional or general anesthesia and involves the following main steps: Positioning of the patient; Definition of the CCD-angle; Fracture reduction; Determination of the nail diameter; Incision; Insertion of the device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bone/fracture- or implant/surgery-related fracture fixation complication events	6 and 12 weeks, 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Mismatch	Perioperatively
Soft tissue/wound -related or general complications	6 and 12 weeks, 6 and 12 months
Health-related quality of life assessed by the generic SF-36-instrument and EQ-5D	Baseline, 6 and 12 months
Walking ability (Parker mobility score)	Baseline, 6 and 12 months
Range of motion (ROM)	6 and 12 weeks, 6 and 12 months
Mortality	6 and 12 weeks, 6 and 12 months
Surgery details and postoperative treatment	till 12 weeks after surgery
Length of hospital stay	till 12 weeks after surgery
Capacity to return to pre-residential status	12 weeks
Bone consolidation and anatomical restoration	6 and 12 weeks, 6 and 12 months

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Collaborators: Synthes Inc.
• Investigators: Principal Investigator: Takeshi Sawaguchi, MD, Toyama Municipal Hospital

Publications and helpful links

General Publications

• 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.
• Schipper IB, Marti RK, van der Werken C. Unstable trochanteric femoral fractures: extramedullary or intramedullary fixation. Review of literature. Injury. 2004 Feb;35(2):142-51. doi: 10.1016/s0020-1383(03)00287-0.
• Nakamura T, Turner CH, Yoshikawa T, Slemenda CW, Peacock M, Burr DB, Mizuno Y, Orimo H, Ouchi Y, Johnston CC Jr. Do variations in hip geometry explain differences in hip fracture risk between Japanese and white Americans? J Bone Miner Res. 1994 Jul;9(7):1071-6. doi: 10.1002/jbmr.5650090715.
• Simmermacher RK, Ljungqvist J, Bail H, Hockertz T, Vochteloo AJ, Ochs U, Werken Cv; AO - PFNA studygroup. The new proximal femoral nail antirotation (PFNA) in daily practice: results of a multicentre clinical study. Injury. 2008 Aug;39(8):932-9. doi: 10.1016/j.injury.2008.02.005. Epub 2008 Jun 25.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: March 31, 2009
• First Submitted That Met QC Criteria: March 31, 2009
• First Posted (Estimate): April 1, 2009

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: PFNA_Asia