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

Trochanteric Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873548
• Other study ID #: PFNA_Asia
• Status: Completed
• Start date: November 2007
• Est. completion date: March 2012

Study information

• Verified date: January 2013
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Trochanteric Fractures

Intervention

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

Locations

Country	Name	City	State
Japan	Toyama Municipal Hospital	Toyama

Sponsors (2)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation	Synthes Inc.

Country where clinical trial is conducted

Japan, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

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