NCT00873548

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 22, 2021

Status Verified

January 1, 2013

Enrollment Period

4.1 years

First QC Date

March 31, 2009

Last Update Submit

July 21, 2021

Conditions

Trochanteric Fractures

Outcome Measures

Primary Outcomes (1)

  • Bone/fracture- or implant/surgery-related fracture fixation complication events

    6 and 12 weeks, 6 and 12 months

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (1)

PFNA_Asia treated

Device: PFNA-Asia

Interventions

PFNA-AsiaDEVICE

The operation is performed under regional or general anesthesia and involves the following main steps: 1. Positioning of the patient 2. Definition of the CCD-angle 3. Fracture reduction 4. Determination of the nail diameter 5. Incision 6. Insertion of the device

PFNA_Asia treated

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute trochanteric fractures at surgery/ orthopedic departments

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toyama Municipal Hospital

Toyama, 939-8511, Japan

Location

Related Publications (4)

  • 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.

    PMID: 14736471BACKGROUND

  • 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.

    PMID: 7942154BACKGROUND

  • 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.

    PMID: 18582887BACKGROUND

  • 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

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Takeshi Sawaguchi, MD

    Toyama Municipal Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 1, 2009

Study Start

November 1, 2007

Primary Completion

December 1, 2011

Study Completion

March 1, 2012

Last Updated

July 22, 2021

Record last verified: 2013-01

Locations

JP(1)