Clinical trial NCT00873548: Treatment of Unstable Trochanteric Fractures With the Proximal Femoral Nail - Antirotation (PFNA)-Asia
Official title: Treatment of Unstable Trochanteric Fractures With the Proximal Femoral Nail - Antirotation Asia - A Prospective Multicenter Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trochanteric Fractures
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: Synthes Inc.
First posted: 2009-04-01
Enrollment: 245
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute trochanteric fractures at surgery/ orthopedic departments

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.

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 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

Primary outcomes:
measure: Bone/fracture- or implant/surgery-related fracture fixation complication events
timeFrame: 6 and 12 weeks, 6 and 12 months
Secondary outcomes:
measure: Mismatch
timeFrame: Perioperatively
measure: Soft tissue/wound -related or general complications
timeFrame: 6 and 12 weeks, 6 and 12 months
measure: Health-related quality of life assessed by the generic SF-36-instrument and EQ-5D
timeFrame: Baseline, 6 and 12 months
measure: Walking ability (Parker mobility score)
timeFrame: Baseline, 6 and 12 months
measure: Range of motion (ROM)
timeFrame: 6 and 12 weeks, 6 and 12 months
measure: Mortality
timeFrame: 6 and 12 weeks, 6 and 12 months
measure: Surgery details and postoperative treatment
timeFrame: till 12 weeks after surgery
measure: Length of hospital stay
timeFrame: till 12 weeks after surgery
measure: Capacity to return to pre-residential status
timeFrame: 12 weeks
measure: Bone consolidation and anatomical restoration
timeFrame: 6 and 12 weeks, 6 and 12 months
Other outcomes:
Locations:
city: Toyama
country: Japan
facility: Toyama Municipal Hospital
Study officials:
affiliation: Toyama Municipal Hospital
name: Takeshi Sawaguchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s0020-1383(03)00287-0.
citation: 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.
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.
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. doi: 10.1016/s0020-1383(99)00091-1.