Trochanteric FracturesNCT00873548
Treatment of Unstable Trochanteric Fractures With the Proximal Femoral Nail - Antirotation (PFNA)-Asia
An observational study of Trochanteric Fractures, run by AO Clinical Investigation and Publishing Documentation at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Trochanteric Fractures
- What is being tested?
- PFNA-Asia
- Type of treatment
- Medical device
- How many people
- 245 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2007to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with acute trochanteric fractures at surgery/ orthopedic departments
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Unstable Trochanteric Fractures With the Proximal Femoral Nail - Antirotation Asia - A Prospective Multicenter Case Series
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.
Read the 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.
- Conditions
- Trochanteric Fractures
- Being tested
- PFNA-Asia
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFNA-AsiaDevice
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
| Study group | Role | What they receive |
|---|---|---|
| PFNA_Asia treated | Not described Receives: Device: PFNA-Asia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone/fracture- or implant/surgery-related fracture fixation complication events
Measured: 6 and 12 weeks, 6 and 12 months
Secondary outcomes (10)
Mismatch
Measured: Perioperatively
Soft tissue/wound -related or general complications
Measured: 6 and 12 weeks, 6 and 12 months
Health-related quality of life assessed by the generic SF-36-instrument and EQ-5D
Measured: Baseline, 6 and 12 months
Walking ability (Parker mobility score)
Measured: Baseline, 6 and 12 months
Range of motion (ROM)
Measured: 6 and 12 weeks, 6 and 12 months
Mortality
Measured: 6 and 12 weeks, 6 and 12 months
Surgery details and postoperative treatment
Measured: till 12 weeks after surgery
Length of hospital stay
Measured: till 12 weeks after surgery
Capacity to return to pre-residential status
Measured: 12 weeks
Bone consolidation and anatomical restoration
Measured: 6 and 12 weeks, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startNov 2007
- Primary completionDec 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Trochanteric FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Collaborators
- Synthes Inc.
- Responsible party
- Sponsor
- Investigators
- Takeshi Sawaguchi, MD, Principal investigator, Toyama Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873548
- Sponsor's protocol ID
- PFNA_Asia
- Status last verified
- Jan 2013
- First submitted
- 31 Mar 2009
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14736471Nakamura 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.
PubMed 7942154Simmermacher 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.
PubMed 18582887Simmermacher 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.
PubMed 10505125
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Unstable Trochanteric Fractures With the Proximal Femoral Nail - Antirotation Asia - A Prospective Multicenter Case Series
- ClinicalTrials.gov ID
- NCT00873548
- Acronym / sponsor ID
- PFNA_Asia
- Conditions
- Trochanteric Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Collaborators
- Synthes Inc.
- Study start
- Nov 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 1 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PFNA_Asia treated | – | Device: PFNA-Asia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with acute trochanteric fractures at surgery/ orthopedic departments
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFNA-AsiaThe 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 | Device | PFNA_Asia treated |
Primary outcome
Bone/fracture- or implant/surgery-related fracture fixation complication events
Time frame: 6 and 12 weeks, 6 and 12 months
10 secondary outcomes
Mismatch
Time frame: Perioperatively
Soft tissue/wound -related or general complications
Time frame: 6 and 12 weeks, 6 and 12 months
Health-related quality of life assessed by the generic SF-36-instrument and EQ-5D
Time frame: Baseline, 6 and 12 months
Walking ability (Parker mobility score)
Time frame: Baseline, 6 and 12 months
Range of motion (ROM)
Time frame: 6 and 12 weeks, 6 and 12 months
Mortality
Time frame: 6 and 12 weeks, 6 and 12 months
Surgery details and postoperative treatment
Time frame: till 12 weeks after surgery
Length of hospital stay
Time frame: till 12 weeks after surgery
Capacity to return to pre-residential status
Time frame: 12 weeks
Bone consolidation and anatomical restoration
Time frame: 6 and 12 weeks, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Background: PubMed 14736471Schipper 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.
- Background: PubMed 7942154Nakamura 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.
- Background: PubMed 18582887Simmermacher 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.
- Background: PubMed 10505125Simmermacher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takeshi Sawaguchi, MD principal investigator
Toyama Municipal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trochanteric Fractures, run by AO Clinical Investigation and Publishing Documentation at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone/fracture- or implant/surgery-related fracture fixation complication events (time frame: 6 and 12 weeks, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00873548, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.