Unstable Trochanteric FracturesPhase 4PROGAINT-ESNCT00736684
Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures
A Phase 4 study testing Proximal Femoral Nail AntirotationTM (PFNA) and Gamma Nail 3TM (Gamma3) in people with Unstable Trochanteric Fractures, run by AO Clinical Investigation and Publishing Documentation at 6 sites in Spain.
Trial summary
The purpose of this study is to compare rates of any fracture fixation complication and revision rates after intramedullary fixation of unstable trochanteric fractures between the Proximal Femoral Nail Antirotation™ (PFNA)(Investigational Group) and Gamma Nail 3™ (Gamma3) (Control Group). Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unstable Trochanteric Fractures
- What is being tested?
- Proximal Femoral Nail AntirotationTM (PFNA) and Gamma Nail 3TM (Gamma3)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 6 sitesSpain
- Study dates
- Nov 2007to Sep 2010
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 55 years and more
- Patients with isolated, unstable, closed or type 1 open trochanteric fractures, classified as AO 31-A2 or AO 31-A3
- Definitive primary fracture treatment with PFNA or Gamma3 (defined inTable 1) within three days after the index event
- Signed written informed consent (by the subjects or legal guardian) and agreement to attend the planned follow-ups
Who cannot join
- Pathologic fracture of any other cause than osteoporosis
- Patients or legal guardian refusing to sign the informed consent form
- Multiple trauma
- Type 2 and 3 open fractures
- Drug or alcohol abuse
- Wound and/or bone healing disorders of any other cause than diabetes mellitus or smoking
Show all 11Show fewer
- Active malignancy
- Expected life expectancy ≤ 3 months
- Inability to walk independently prior to injury event (use of one stick is allowed. Not meeting inclusion criteria are bedridden, wheel-chair ridden and walker dependent subjects)
- Neurological and psychiatric disorders that would preclude reliable assessment (eg,, Parkinson disease, Multiple sclerosis, severe depression)
- Rheumatoid arthritis
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Clinic
Barcelona, Catalonia, 08036
Hospital Gregorio Marañon
Madrid, Madrid, 28007
Hospital Puerta de Hierro
Madrid, Madrid, 28035
H.U. Virgen de la Arrixaca
Murcia, 30071
Hospital Donostia
San Sebastián, 20014
Hospital Universitario "Marqués de Valdecilla"
Santander, Cantabria, 39008
About this study
Official title: Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures - a Multicenter Randomized Controlled Trial
The purpose of this study is to compare rates of any fracture fixation complication and revision rates after intramedullary fixation of unstable trochanteric fractures between the Proximal Femoral Nail Antirotation™ (PFNA)(Investigational Group) and Gamma Nail 3™ (Gamma3) (Control Group).
Read the detailed description
Intramedullary nailing of unstable per- and subtrochanteric femoral fractures is a standard procedure in trauma and orthopaedic surgery. Unstable fractures treated with intramedullary nailing carry the risk of fracture fixation complications. The PFNA (Synthes) has evolved from the original PFN design, featuring a novel antirotation screw. Apart from the prevention of excess rotational forces, this supporting element may enhance the overall stability of the construct, thus potentially reducing fracture fixation complications. Empirical information about the fracture fixation complication rates of the PFNA device is not available. The primary objective of this study is to compare the 1-year fracture fixation rates between the PFNA and Gamma Nail 3™ (Stryker). Secondary objectives of the study are to compare differences in functional outcomes, quality of life outcomes, safety, radiological outcomes, handling and perceived effectiveness between the devices.
- Conditions
- Unstable Trochanteric Fractures
- Being tested
- Proximal Femoral Nail AntirotationTM (PFNA), Gamma Nail 3TM (Gamma3)
- Keywords
- Femoral fractures [MeSH], hip fractures [MeSH], trochanteric fractures (femoral neck fractures [MeSH]), intramedullary nailing (fracture fixation, intramedullary [MeSH]), complex femoral fractures, femoral nail, surgical treatment (surgical procedures, operative [MeSH]), complications
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal Femoral Nail AntirotationTM (PFNA)Device
intramedullary nailing
Gamma Nail 3TM (Gamma3)Device
intramedullary nailing
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Proximal Femoral Nail AntirotationTM (PFNA) Receives: Device: Proximal Femoral Nail AntirotationTM (PFNA) |
| 2 | Other | Gamma Nail 3TM (Gamma3) Receives: Device: Gamma Nail 3TM (Gamma3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any fracture fixation complication.
Measured: One year
Secondary outcomes (1)
Bone union/fusion as evaluated by CT-scanning, health-related quality of life, disease-specific functional scoring, activities of daily living, mortality, radiological parameters, surgery details and surgeons' evaluation of handling and effectiveness.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unstable 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Collaborators
- Synthes Inc.
- Investigators
- Beate P. Hanson, MD, Study director, AO Clinical Investigation and Documentation, Davos, SwitzerlandJavier Vaquero Martin, MD, Principal investigator, Hospital Gregorio Marañon, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736684
- Sponsor's protocol ID
- PROGAINT-ES-08
- Acronym
- PROGAINT-ES
- Status last verified
- Feb 2011
- First submitted
- 15 Aug 2008
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures - a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00736684
- Acronym / sponsor ID
- PROGAINT-ES / PROGAINT-ES-08
- Conditions
- Unstable Trochanteric Fractures
- Keywords
- Femoral fractures [MeSH], hip fractures [MeSH], trochanteric fractures (femoral neck fractures [MeSH]), intramedullary nailing (fracture fixation, intramedullary [MeSH]), complex femoral fractures, femoral nail, surgical treatment (surgical procedures, operative [MeSH]), complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Collaborators
- Synthes Inc.
- Study start
- Nov 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 18 Aug 2008 (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 compare rates of any fracture fixation complication and revision rates after intramedullary fixation of unstable trochanteric fractures between the Proximal Femoral Nail Antirotation™ (PFNA)(Investigational Group) and Gamma Nail 3™ (Gamma3) (Control Group).
Detailed description
Intramedullary nailing of unstable per- and subtrochanteric femoral fractures is a standard procedure in trauma and orthopaedic surgery. Unstable fractures treated with intramedullary nailing carry the risk of fracture fixation complications. The PFNA (Synthes) has evolved from the original PFN design, featuring a novel antirotation screw. Apart from the prevention of excess rotational forces, this supporting element may enhance the overall stability of the construct, thus potentially reducing fracture fixation complications. Empirical information about the fracture fixation complication rates of the PFNA device is not available. The primary objective of this study is to compare the 1-year fracture fixation rates between the PFNA and Gamma Nail 3™ (Stryker). Secondary objectives of the study are to compare differences in functional outcomes, quality of life outcomes, safety, radiological outcomes, handling and perceived effectiveness between the devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Proximal Femoral Nail AntirotationTM (PFNA)Proximal Femoral Nail AntirotationTM (PFNA) |
| 2 | Other | Device: Gamma Nail 3TM (Gamma3)Gamma Nail 3TM (Gamma3) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 55 years and more
- Patients with isolated, unstable, closed or type 1 open trochanteric fractures, classified as AO 31-A2 or AO 31-A3
- Definitive primary fracture treatment with PFNA or Gamma3 (defined inTable 1) within three days after the index event
- Signed written informed consent (by the subjects or legal guardian) and agreement to attend the planned follow-ups
Key exclusion criteria (11 listed)
- Pathologic fracture of any other cause than osteoporosis
- Patients or legal guardian refusing to sign the informed consent form
- Multiple trauma
- Type 2 and 3 open fractures
- Drug or alcohol abuse
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 |
|---|---|---|
| Proximal Femoral Nail AntirotationTM (PFNA)intramedullary nailing | Device | 1 |
| Gamma Nail 3TM (Gamma3)intramedullary nailing | Device | 2 |
Primary outcome
Any fracture fixation complication.
Time frame: One year
1 secondary outcome
Bone union/fusion as evaluated by CT-scanning, health-related quality of life, disease-specific functional scoring, activities of daily living, mortality, radiological parameters, surgery details and surgeons' evaluation of handling and effectiveness.
Time frame: One year
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 11 Feb 2011.
Related trials for Unstable Trochanteric Fractures
Recruiting
Intramedullary Nail Versus Hip Arthroplasty in Unstable Trochanteric Hip Fractures
Hip Injuries and Disorders, Hip Fractures
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.
Beate P. Hanson, MD study director
AO Clinical Investigation and Documentation, Davos, Switzerland
Javier Vaquero Martin, MD principal investigator
Hospital Gregorio Marañon, Madrid, Spain
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Proximal Femoral Nail AntirotationTM (PFNA) and Gamma Nail 3TM (Gamma3) in people with Unstable Trochanteric Fractures, run by AO Clinical Investigation and Publishing Documentation at 6 sites in Spain.
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 4 inclusion and 11 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 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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?
Any fracture fixation complication. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2011.