Hip FracturesPhase 4NCT01473082
Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation
A Phase 4 study testing PFNA Augmentation (Synthes) and PFNA (Synthes) in people with Hip Fractures and Closed Fracture of Hip, run by AO Clinical Investigation and Publishing Documentation at 9 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate whether patients with trochanteric fractures being treated with a Proximal Femoral Nail Antirotation (PFNA) and augmentation can better be mobilized than patients without augmentation. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Hip Fractures, Closed Fracture of Hip
- What is being tested?
- PFNA Augmentation (Synthes) and PFNA (Synthes)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 9 sitesin 6 countries
- Study dates
- Feb 2012to Jan 2016
- Phase
- Phase 4
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 75 years and older
- Closed unstable trochanteric fracture: AO 31 - A2 and A3
- Low energy trauma (e.g.fall from standing height)
- Definitive fracture fixation within 72 hrs. after admission
- Indication for PFNA fixation (with or without augmentation)
- Ability to walk independently (walking aids are allowed) prior to injury
- Signed written informed consent and agreement to attend the planned FUs
- Able to understand and read country national language at an elementary level
Who cannot join
- Pathologic fracture
- Polytrauma
- Any additional fracture
- Open fracture
- Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
- Active malignancy defined as history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and symptoms for at least five years
Show all 19Show fewer
- ASA class V and VI
- Any implant at the same hip
- Hemiplegia
- Patients with legal guardian
- Patients who have participated in any other device or drug related clinical trial that could influence the results of the present study within the previous month
- Fractures and injuries opening into the articulation and vascular structure
- Infection
- Patients with clotting disorders
- Patients with severe cardiac and / or pulmonary insufficiency
- Patients with known hypersensitivity or allergy to any of the components of Traumacem V+ cement (Polymethyl methacrylate / acrylate, zirconium dioxide, hydroxyapatite,benzoyl peroxide, methyl methacrylate,hydroquinone, N,N-dimethyl-p-toluidine)
- Perforation of the femoral head into the joint with the guide wire used for the PFNA blade
- Risk of potential leakage into the joint identified by using contrast fluid (PFNA Augmentation group only)
- Intraoperative decision to use implants other than PFNA
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Germany3 sites
BGU Tübingen
Tübingen, 72076
University of Ulm
Ulm, 89075
Sophien und Hufeland Klinikum GmbH
Weimar, 99425
Switzerland2 sites
Cantonal Hospital Lucerne
Lucerne, 6000
City Hospital Waid
Zurich, 8037
About this study
Official title: Comparison of Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation for the Treatment of Closed Unstable Trochanteric Fractures - A Randomized-controlled Trial
The purpose of this study is to evaluate whether patients with trochanteric fractures being treated with a Proximal Femoral Nail Antirotation (PFNA) and augmentation can better be mobilized than patients without augmentation.
Read the detailed description
To avoid the pain-causing relative movement between implant and bone, surgical techniques and devices allowing augmentation of the femoral head have recently been developed. Biomechanical studies showed that augmentation leads to a better axial stability and pull-out strength. In clinical practice, this might facilitate early mobilization and full weight-bearing with less pain. The purpose of this study is therefore to evaluate whether patients with trochanteric fractures being treated with a PFNA and augmentation can better be mobilized than patients without augmentation. In particular, it will be measured whether patients with a PFNA Augmentation can walk faster than the non-augmented patients, measured with the Timed up and Go test.
- Conditions
- Hip Fractures, Closed Fracture of Hip
- Being tested
- PFNA Augmentation (Synthes), PFNA (Synthes)
- 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 Augmentation (Synthes)Device
Also called PFNA Augmentation (Synthes) length 240 mm, PFNA Augmentation (Synthes) small length 200 mm, PFNA Augmentation (Synthes) xs length 170 mm, PFNA Augmentation (Synthes) long lengths 300-420 mm
Proximal Femoral Nail Antirotation (PFNA) Augmentation (with Traumacem V+)
PFNA (Synthes)Device
Also called PFNA length 240 mm, PFNA small length 200 mm, PFNA xs length 170 mm, PFNA long lengths 300-420 mm
Proximal Femoral Nail Antirotation (PFNA)
| Study group | Role | What they receive |
|---|---|---|
| PFNA | Active comparator | Proximal Femoral Nail Antirotation (PFNA Synthes) Receives: Device: PFNA (Synthes) |
| PFNA Augmentation | Active comparator | Proximal Femoral Nail Antirotation PFNA Augmentation (Synthes) with Traumacem V+ Synthes Receives: Device: PFNA Augmentation (Synthes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility measured with the "timed up & go"-test during hospital stay.
The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seat position is reached again. Patient-perceived pain and exertion will be assessed after the test.
Measured: 5 to 7 days postoperative
Secondary outcomes (14)
Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only).
Measured: Intraoperative
Pain
Pain, measured with the Numerical Rating Scale (NRS) and use of pain medication postoperative.
Measured: one year
Duration of hospital stay
Measured: one year
Walking ability
Parker Mobility Score
Measured: one year
Return to pre-fracture residential status
Measured: one year
Timed up & go-test at follow-ups
The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seat position is reached again.
Measured: one year
Quality of life
EuroQol-5D
Measured: one year
Local adverse events and revision rate
Implant / surgery, bone / fracture, soft tissue of the musculoskeletal system, wound related adverse events
Measured: one year
Systemic adverse events
Measured: one year
Implant migration
Measured at the CT in a subgroup only
Measured: one year
Mortality
Measured: one year
Fracture risk prior to injury
Measured with the Fracture Risk Assessment Tool (FRAX)
Measured: 1 week prior to operation
Functional independence
Measured with the Barthel Index
Measured: 1 week prior to operation
Comorbidity
Charlson Comorbidiy Index
Measured: 1 week prior to operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startFeb 2012
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Faeh, Study director, AO Clinical Investigation and Documentation, Davos, SwitzerlandChristian Kammerlander, MD, Principal investigator, Medical University of Innsbruck, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473082
- Sponsor's protocol ID
- PFNA augmented
- Status last verified
- Jul 2018
- First submitted
- 10 Nov 2011
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kammerlander C, Hem ES, Klopfer T, Gebhard F, Sermon A, Dietrich M, Bach O, Weil Y, Babst R, Blauth M. Cement augmentation of the Proximal Femoral Nail Antirotation (PFNA) - A multicentre randomized controlled trial. Injury. 2018 Aug;49(8):1436-1444. doi: 10.1016/j.injury.2018.04.022. Epub 2018 Apr 22.
PubMed 29724590
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation for the Treatment of Closed Unstable Trochanteric Fractures - A Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT01473082
- Acronym / sponsor ID
- PFNA augmented
- Conditions
- Hip Fractures, Closed Fracture of Hip
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 17 Nov 2011 (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 purpose of this study is to evaluate whether patients with trochanteric fractures being treated with a Proximal Femoral Nail Antirotation (PFNA) and augmentation can better be mobilized than patients without augmentation.
Detailed description
To avoid the pain-causing relative movement between implant and bone, surgical techniques and devices allowing augmentation of the femoral head have recently been developed. Biomechanical studies showed that augmentation leads to a better axial stability and pull-out strength. In clinical practice, this might facilitate early mobilization and full weight-bearing with less pain. The purpose of this study is therefore to evaluate whether patients with trochanteric fractures being treated with a PFNA and augmentation can better be mobilized than patients without augmentation. In particular, it will be measured whether patients with a PFNA Augmentation can walk faster than the non-augmented patients, measured with the Timed up and Go test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFNA | Active comparator | Device: PFNA (Synthes)Proximal Femoral Nail Antirotation (PFNA Synthes) |
| PFNA Augmentation | Active comparator | Device: PFNA Augmentation (Synthes)Proximal Femoral Nail Antirotation PFNA Augmentation (Synthes) with Traumacem V+ Synthes |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Age 75 years and older
- Closed unstable trochanteric fracture: AO 31 - A2 and A3
- Low energy trauma (e.g.fall from standing height)
- Definitive fracture fixation within 72 hrs. after admission
- Indication for PFNA fixation (with or without augmentation)
Key exclusion criteria (19 listed)
- Pathologic fracture
- Polytrauma
- Any additional fracture
- Open fracture
- Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
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 Augmentation (Synthes)Also: PFNA Augmentation (Synthes) length 240 mm, PFNA Augmentation (Synthes) small length 200 mm, PFNA Augmentation (Synthes) xs length 170 mm, PFNA Augmentation (Synthes) long lengths 300-420 mmProximal Femoral Nail Antirotation (PFNA) Augmentation (with Traumacem V+) | Device | PFNA Augmentation |
| PFNA (Synthes)Also: PFNA length 240 mm, PFNA small length 200 mm, PFNA xs length 170 mm, PFNA long lengths 300-420 mmProximal Femoral Nail Antirotation (PFNA) | Device | PFNA |
Primary outcome
Mobility measured with the "timed up & go"-test during hospital stay.
Time frame: 5 to 7 days postoperative
The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seat position is reached again. Patient-perceived pain and exertion will be assessed after the test.
14 secondary outcomes
Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only).
Time frame: Intraoperative
Pain
Time frame: one year
Duration of hospital stay
Time frame: one year
Walking ability
Time frame: one year
Return to pre-fracture residential status
Time frame: one year
Timed up & go-test at follow-ups
Time frame: one year
Quality of life
Time frame: one year
Local adverse events and revision rate
Time frame: one year
Systemic adverse events
Time frame: one year
Implant migration
Time frame: one year
Mortality
Time frame: one year
Fracture risk prior to injury
Time frame: 1 week prior to operation
Functional independence
Time frame: 1 week prior to operation
Comorbidity
Time frame: 1 week prior to operation
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 13 Aug 2020.
- Results publication: PubMed 29724590Kammerlander C, Hem ES, Klopfer T, Gebhard F, Sermon A, Dietrich M, Bach O, Weil Y, Babst R, Blauth M. Cement augmentation of the Proximal Femoral Nail Antirotation (PFNA) - A multicentre randomized controlled trial. Injury. 2018 Aug;49(8):1436-1444. doi: 10.1016/j.injury.2018.04.022. Epub 2018 Apr 22.
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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.
Andreas Faeh study director
AO Clinical Investigation and Documentation, Davos, Switzerland
Christian Kammerlander, MD principal investigator
Medical University of Innsbruck, Austria
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PFNA Augmentation (Synthes) and PFNA (Synthes) in people with Hip Fractures and Closed Fracture of Hip, run by AO Clinical Investigation and Publishing Documentation at 9 sites in 6 countries.
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 8 inclusion and 19 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 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Switzerland, Austria, Belgium, Israel and 1 more country. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mobility measured with the "timed up & go"-test during hospital stay. (time frame: 5 to 7 days postoperative). 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 NCT01473082, which also lists 1 linked publication.
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 13 Aug 2020.