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Completed

NCT Number: NCT00873548

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Toyama Municipal Hospital

Toyama, 939-8511, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PFNA-Asia

Device

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

Primary outcomes

  1. Bone/fracture- or implant/surgery-related fracture fixation complication events

    Time frame: 6 and 12 weeks, 6 and 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Collaborators

  • Synthes Inc.

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Apr 1, 2009
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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