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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00873548
Recruitment Status : Completed
First Posted : April 1, 2009
Last Update Posted : January 25, 2013
Synthes Inc.
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

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.

Condition or disease Intervention/treatment
Trochanteric Fractures 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
Actual Enrollment : 245 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Treatment of Unstable Trochanteric Fractures With the Proximal Femoral Nail - Antirotation Asia - A Prospective Multicenter Case Series
Study Start Date : November 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

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:

  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

Primary Outcome Measures :
  1. Bone/fracture- or implant/surgery-related fracture fixation complication events [ Time Frame: 6 and 12 weeks, 6 and 12 months ]

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

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute trochanteric fractures at surgery/ orthopedic departments

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00873548

Toyama Municipal Hospital
Toyama, Japan, 939-8511
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Synthes Inc.
Principal Investigator: Takeshi Sawaguchi, MD Toyama Municipal Hospital