Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Synthes Inc.
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00873548
First received: March 31, 2009
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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 Intervention
Trochanteric Fractures
Device: PFNA-Asia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Bone/fracture- or implant/surgery-related fracture fixation complication events [ Time Frame: 6 and 12 weeks, 6 and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mismatch [ Time Frame: Perioperatively ] [ Designated as safety issue: Yes ]
  • Soft tissue/wound -related or general complications [ Time Frame: 6 and 12 weeks, 6 and 12 months ] [ Designated as safety issue: No ]
  • Health-related quality of life assessed by the generic SF-36-instrument and EQ-5D [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • Walking ability (Parker mobility score) [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • Range of motion (ROM) [ Time Frame: 6 and 12 weeks, 6 and 12 months ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 6 and 12 weeks, 6 and 12 months ] [ Designated as safety issue: No ]
  • Surgery details and postoperative treatment [ Time Frame: till 12 weeks after surgery ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: till 12 weeks after surgery ] [ Designated as safety issue: No ]
  • Capacity to return to pre-residential status [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Bone consolidation and anatomical restoration [ Time Frame: 6 and 12 weeks, 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 245
Study Start Date: November 2007
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with acute trochanteric fractures at surgery/ orthopedic departments

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873548

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