Unstable Proximal Femoral FracturePFN-ANCT02038686
Treatment of Unstable 31.A2 and 31.A3 Trochanteric Fractures. Randomised Comparison of the Proximal Femoral Nail PFN-A Short and the PFN-A Long.
A study testing PFN-A in people with Unstable Proximal Femoral Fracture, run by Ferran Fillat Gomà at 1 site in Spain.
Trial summary
1. Introduction: Controversy exists with regard to whether to treat AO/OTA (Orthopaedic Trauma Association) 32.A2 - 32-A3 fractures of the proximal part of the femur with an intramedullary short PFN-A or long PFN-A. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Unstable Proximal Femoral Fracture
- What is being tested?
- PFN-A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Jan 2017
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 60 years old above.
- Patients with trochanteric fracture 31.A2 and 31.A3 AO classification for long bones
- Patients that accept to participate on the study under consent
Who cannot join
- Metaphyseal fractures with extension more than 3 cm in reference to lesser trochanter calibrated and analyzed with PreOPlan registered application.
- Combination of fractures in the proximal femur.
- Pathological fractures.
- Diaphyseal femoral fractures.
- Rejection of surgery by the patient.
- Contraindications to the use of either implants studied.
- Patients who do not wish to participate in this study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Parc Taulí de Sabadell
Sabadell, Barcelona, 08208
About this study
- Introduction: Controversy exists with regard to whether to treat AO/OTA (Orthopaedic Trauma Association) 32.A2 - 32-A3 fractures of the proximal part of the femur with an intramedullary short PFN-A or long PFN-A. A prospective, randomized, controlled trial is performed to compare the outcome treatment of these unstable fractures of the proximal part of the femur with either a short PFN-A (170-240mm) or long PFN-A (300-420mm).
- Objectives and Hypothesis The hypothesis is that the Short PFN-A would have fewer complications than Long PFN-A Main Objective: Is defined as Total number of complications between PFN-A short and PFN-A long. Outcome measures were subdivided into preoperative, perioperative and post-operative. Follow up data at four weeks, three months and one year. Secondary objectives: Complete and uneventful radiological and clinical healing of the fracture. Revision operations (related to the failure of primary treatment) and mortality. Baseline characteristics were documented pre-operatively: Outcome measures were subdivided into intra-operative, post-operative and follow up data at four weeks, three months and one year.
- Methodology: One hundred and eighty eight patients presenting with an AO/OTA 31-A2 and 31-A3 fracture of the proximal part of the femur will be randomized, at the time of the admission, to fixation with use either a short PFN-A or a long PFN-A.
- Conditions
- Unstable Proximal Femoral Fracture
- Being tested
- PFN-A
- Keywords
- Hip fracture, Unstable (31A2 and 31A3), Proximal femoral nail
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFN-ADevice
Also called Proximal femoral nail Synthes
| Study group | Role | What they receive |
|---|---|---|
| Standard PFN-A | Active comparator | Patients with unstable proximal femoral fractures treated with PFN-A short nail (170-240mm) Receives: Device: PFN-A |
| Long PFN-A | Active comparator | Patients with unstable proximal femoral fractures treated with PFN-A long nail (300-420mm) Receives: Device: PFN-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of complications between PFN-A short and PFN-A long
follow-up data is recruited at 4 weeks, 3 months and one
Measured: One year
Secondary outcomes (1)
Complete and uneventful radiological and clinical healing of the fracture and mortality
follow-up data is recruited at 4 weeks, 3 months and one year.
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 posted16 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unstable Proximal Femoral FractureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferran Fillat Gomà
- Sponsor type
- University, hospital or other
- Collaborators
- Parc Taulí Hospital Universitari
- Responsible party
- Sponsor-investigator, Ferran Fillat Gomà, Corporacion Parc Tauli
- Investigators
- Ferran Fillat-Gomà, MD, Principal investigator, Hospital Universitario Parc Tauli de SabadellJoan Murias-Álvarez, MD, Study director, Hospital Universitario Parc Tauli de Sabadell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038686
- Sponsor's protocol ID
- CSPTCOT2013/01
- Acronym
- PFN-A
- Status last verified
- Feb 2017
- First submitted
- 15 Jan 2014
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Unstable 31.A2 and 31.A3 Trochanteric Fractures. Randomised Comparison of the Proximal Femoral Nail PFN-A Short and the PFN-A Long.
- ClinicalTrials.gov ID
- NCT02038686
- Acronym / sponsor ID
- PFN-A / CSPTCOT2013/01
- Conditions
- Unstable Proximal Femoral Fracture
- Keywords
- Hip fracture, Unstable (31A2 and 31A3), Proximal femoral nail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Ferran Fillat GomàUniversity, hospital or other
- Collaborators
- Parc Taulí Hospital Universitari
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 16 Jan 2014 (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.
- Introduction: Controversy exists with regard to whether to treat AO/OTA (Orthopaedic Trauma Association) 32.A2 - 32-A3 fractures of the proximal part of the femur with an intramedullary short PFN-A or long PFN-A. A prospective, randomized, controlled trial is performed to compare the outcome treatment of these unstable fractures of the proximal part of the femur with either a short PFN-A (170-240mm) or long PFN-A (300-420mm).
- Objectives and Hypothesis The hypothesis is that the Short PFN-A would have fewer complications than Long PFN-A Main Objective: Is defined as Total number of complications between PFN-A short and PFN-A long. Outcome measures were subdivided into preoperative, perioperative and post-operative. Follow up data at four weeks, three months and one year. Secondary objectives: Complete and uneventful radiological and clinical healing of the fracture. Revision operations (related to the failure of primary treatment) and mortality. Baseline characteristics were documented pre-operatively: Outcome measures were subdivided into intra-operative, post-operative and follow up data at four weeks, three months and one year.
- Methodology: One hundred and eighty eight patients presenting with an AO/OTA 31-A2 and 31-A3 fracture of the proximal part of the femur will be randomized, at the time of the admission, to fixation with use either a short PFN-A or a long PFN-A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard PFN-A | Active comparator | Device: PFN-APatients with unstable proximal femoral fractures treated with PFN-A short nail (170-240mm) |
| Long PFN-A | Active comparator | Device: PFN-APatients with unstable proximal femoral fractures treated with PFN-A long nail (300-420mm) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 60 years old above.
- Patients with trochanteric fracture 31.A2 and 31.A3 AO classification for long bones
- Patients that accept to participate on the study under consent
Key exclusion criteria (7 listed)
- Metaphyseal fractures with extension more than 3 cm in reference to lesser trochanter calibrated and analyzed with PreOPlan registered application.
- Combination of fractures in the proximal femur.
- Pathological fractures.
- Diaphyseal femoral fractures.
- Rejection of surgery by the patient.
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 |
|---|---|---|
| PFN-AAlso: Proximal femoral nail Synthes | Device | Long PFN-A, Standard PFN-A |
Primary outcome
Total number of complications between PFN-A short and PFN-A long
Time frame: One year
follow-up data is recruited at 4 weeks, 3 months and one
1 secondary outcome
Complete and uneventful radiological and clinical healing of the fracture and mortality
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 2 Feb 2017.
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.
Ferran Fillat-Gomà, MD principal investigator
Hospital Universitario Parc Tauli de Sabadell
Joan Murias-Álvarez, MD study director
Hospital Universitario Parc Tauli de Sabadell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFN-A in people with Unstable Proximal Femoral Fracture, run by Ferran Fillat Gomà at 1 site 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 3 inclusion and 7 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 2 Feb 2017. 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 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.
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?
Total number of complications between PFN-A short and PFN-A long (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 2 Feb 2017.