Pertrochanteric Fractures of FemurFR TFNANCT02305121
Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™)
An observational study of Pertrochanteric Fractures of Femur and Intertrochanteric Fractures of the Femur, run by AO Clinical Investigation and Publishing Documentation at 2 sites in 2 countries.
Trial summary
The aim of this project is the prospective data collection of a new device used for trochanteric fractures of the femur. It should be answered how the newly developed implant called Trochanteric Fixation Nailing with anti-rotation feature (TFNA) is performing clinically and radiological in terms of intra- and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pertrochanteric Fractures of Femur, Intertrochanteric Fractures of the Femur
- What is being tested?
- TFNA
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2015to Nov 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with per- or intertrochanteric fractures of the femur, fracture of the trochanteric area with diaphyseal extension or combined fractures of the trochanteric area and the femoral shaft.
Who may be able to join
- Age 18 years and older
- Pertrochanteric femoral fracture (31-A1 and 31-A2), intertrochanteric fracture (31-A3), fracture of the trochanteric area (31-A1/A2/A3) with diaphyseal extension or combined fracture of the trochanteric area and the femoral shaft (32-A/B/C) treated with the TFNA system according to the technique guide
- Ability to understand the content of the patient information / informed consent form
- Willingness and ability to participate in the registry according to the registry plan (RP)
- Signed and dated IRB/EC-approved written informed consent or assent from a family member
Who cannot join
- Additional acute fracture
- Any not medically managed severe systemic disease
- Recent history of substance abuse (i.e., recreational drugs, alcohol) that would preclude reliable assessment
- Pregnancy or women planning to conceive within the registry period
- Prisoner
- Participation in any other medical device or medicinal product registry within the previous month that could influence the results of the present registry
- Intraoperative decision to use implants other than the devices under investigation
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™) - TFNA System in Patients With Proximal Inter-, Per- or Subtrochanteric Fractures
The aim of this project is the prospective data collection of a new device used for trochanteric fractures of the femur. It should be answered how the newly developed implant called Trochanteric Fixation Nailing with anti-rotation feature (TFNA) is performing clinically and radiological in terms of intra- and postoperative complications.
Read the detailed description
In comparison to previous implants, the TFNA has been improved substantially. Therefore the purpose of this focused registry is to investigate how the newly developed implant called Trochanteric Fixation Nailing with anti-rotation feature (TFNA) is performing clinically and radiologically in terms of surgical technique, intra- and postoperative complications and short term outcome.
All investigated procedures are part of the standard of care treatment. Only the parker mobility score is study-specific. All patients included are followed up from the time point of enrollment until three months after surgery.
- Being tested
- TFNA
- Keywords
- Trochanteric fracture, Nail, Fracture reduction, Antirotation, trochanteric area with diaphyseal extension, trochanteric area with femoral shaft
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TFNADevice
All investigated procedures are part of the standard of care treatment. Only the parker mobility score is study-specific. All patients included are followed up from the time point of enrollment until three months after surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of mechanical and surgical complications defined as the number of
- cut out and cut through
- secondary displacement of parts of the implant
- breakage of the implant
- iatrogenic fractures
- surgical revisions
- acute deep infection
Measured: up to 3 months
Secondary outcomes (4)
OR time
(in min)
Measured: Intraoperative
Fracture classification Classification
according to AO/OTA Fracture and Dislocation
Measured: Baseline
Parker Mobility Score
Evaluation of the mobility
Measured: up to 3 months
Quality of reduction and implant placement
Based on radiographic analysis with focus on the position of the nail tip relative to the femoral canal and the migration of the head neck element
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pertrochanteric Fractures of FemurStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Blauth, Professor, Principal investigator, Medical University Innsbruck, Department of Trauma Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305121
- Sponsor's protocol ID
- FR TFNA
- Acronym
- FR TFNA
- Status last verified
- Aug 2020
- First submitted
- 22 Nov 2014
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™) - TFNA System in Patients With Proximal Inter-, Per- or Subtrochanteric Fractures
- ClinicalTrials.gov ID
- NCT02305121
- Acronym / sponsor ID
- FR TFNA / FR TFNA
- Keywords
- Trochanteric fracture, Nail, Fracture reduction, Antirotation, trochanteric area with diaphyseal extension, trochanteric area with femoral shaft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 2 Dec 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.
The aim of this project is the prospective data collection of a new device used for trochanteric fractures of the femur. It should be answered how the newly developed implant called Trochanteric Fixation Nailing with anti-rotation feature (TFNA) is performing clinically and radiological in terms of intra- and postoperative complications.
Detailed description
In comparison to previous implants, the TFNA has been improved substantially. Therefore the purpose of this focused registry is to investigate how the newly developed implant called Trochanteric Fixation Nailing with anti-rotation feature (TFNA) is performing clinically and radiologically in terms of surgical technique, intra- and postoperative complications and short term outcome.
All investigated procedures are part of the standard of care treatment. Only the parker mobility score is study-specific. All patients included are followed up from the time point of enrollment until three months after surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with per- or intertrochanteric fractures of the femur, fracture of the trochanteric area with diaphyseal extension or combined fractures of the trochanteric area and the femoral shaft.
Key inclusion criteria (5 listed)
- Age 18 years and older
- Pertrochanteric femoral fracture (31-A1 and 31-A2), intertrochanteric fracture (31-A3), fracture of the trochanteric area (31-A1/A2/A3) with diaphyseal extension or combined fracture of the trochanteric area and the femoral shaft (32-A/B/C) treated with the TFNA system according to the technique guide
- Ability to understand the content of the patient information / informed consent form
- Willingness and ability to participate in the registry according to the registry plan (RP)
- Signed and dated IRB/EC-approved written informed consent or assent from a family member
Key exclusion criteria (7 listed)
- Additional acute fracture
- Any not medically managed severe systemic disease
- Recent history of substance abuse (i.e., recreational drugs, alcohol) that would preclude reliable assessment
- Pregnancy or women planning to conceive within the registry period
- Prisoner
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 |
|---|---|---|
| TFNAAll investigated procedures are part of the standard of care treatment. Only the parker mobility score is study-specific. All patients included are followed up from the time point of enrollment until three months after surgery | Device | – |
Primary outcome
The rate of mechanical and surgical complications defined as the number of
Time frame: up to 3 months
* cut out and cut through * secondary displacement of parts of the implant * breakage of the implant * iatrogenic fractures * surgical revisions * acute deep infection
4 secondary outcomes
OR time
Time frame: Intraoperative
Fracture classification Classification
Time frame: Baseline
Parker Mobility Score
Time frame: up to 3 months
Quality of reduction and implant placement
Time frame: up to 3 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 12 Aug 2020.
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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.
Michael Blauth, Professor principal investigator
Medical University Innsbruck, Department of Trauma Surgery
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertrochanteric Fractures of Femur and Intertrochanteric Fractures of the Femur, run by AO Clinical Investigation and Publishing Documentation at 2 sites in 2 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 5 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 12 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 2 sites in Austria, Switzerland. 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?
The rate of mechanical and surgical complications defined as the number of (time frame: up to 3 months). 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 12 Aug 2020.