Thoracic FractureFRIFIXNCT01810094
Minimally Invasive Reduction and Fixation of Thoracolumbar Fractures
An observational study of Thoracic Fracture and Lumbar Fracture, run by Aesculap AG at 4 sites in Germany.
Trial summary
Spinal injuries, such as vertebral fractures, often result in a significant instability of the spine and lead to acute or delayed neurological deficits. Depending on the type of injury there are various methods available to stabilize the spine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Fracture, Lumbar Fracture
- What is being tested?
- Fracture Fixation
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 4 sitesGermany
- Study dates
- Feb 2013to Nov 2016
- 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: adult patients
Who may be able to join
- Minimum age of the patients of 18 years
- Indication for operative treatment of fractures of the thoracic or lumbar spine
- Singular A3.1-3 fractures according to the AO classification system
- Declaration of consent in participation in this study and willingness to the treatment according to the study protocol
- Physical and mental ability to meet the clinical and radiological follow-up plan
Who cannot join
- Additional severe trauma, that makes survey of the patient difficult or impossible influence the results of the fracture treatment significantly
- Additional trauma or fractures of the spine
- Other serious conditions complicating participation in the study
- Systemic or local infections
- Pregnancy or planned pregnancy
- Neurological deficits
Show all 11Show fewer
- Severe blood coagulation disorders diagnosed preoperatively
- Intake of preoperatively anticoagulants
- Osteoporosis
- Bone metabolism disorders
- Laminectomy necessary during surgery results in exclusion of the patient either
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Vinzenz-Pallotti-Hospital
Bergisch Gladbach, 51429
Universitätsklinik Bonn, Abteilung für Unfallchirurgie
Bonn, 53127
Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinik Köln
Cologne, 50924
Abteilung für Orthopädie und Unfallchirurgie, Krankenhaus Wermelskirchen
Wermelskirchen, 42929
About this study
Official title: Prospective Observational Study of Minimally Invasive Fixation of Thoracolumbar Fractures With the Fracture Fixation System S4, Performed With the Fracture Reduction Instrumentation FRI (FRIFIX)
Spinal injuries, such as vertebral fractures, often result in a significant instability of the spine and lead to acute or delayed neurological deficits. Depending on the type of injury there are various methods available to stabilize the spine. The proposed study should clarify whether the combined reduction and fixation with a minimally invasive approach can actually be done with the same precision as in a conventional approach. The primary endpoint of this investigation is the monosegmental anterior wedge angle (AWA), and its maintenance over the first 6 postoperative weeks. It is the aim of the study to gather key radiological, clinical and subjective patient outcome parameters for its patient population that will allow to compare the results to a historical group of patients. The study design is non-interventional, prospective, open,and multicentric.
- Conditions
- Thoracic Fracture, Lumbar Fracture
- Being tested
- Fracture Fixation
- Keywords
- thoracolumbar fracture, fixation, fixateur interne, minimal invasive, percutaneous
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fracture FixationDevice
Thoracolumbar Fracture Fixation
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive Approach | Patients with a thoracolumbar Fracture A3.1 to A 3.3 treated by fracture fixation by a minimally invasive approach Receives: Device: Fracture Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior wedge angle (AWA)
Measured: 6 weeks
Secondary outcomes (8)
Blood loss of the patient during surgery to stabilize the spine fracture
Measured: intraoperative
OP duration
Measured: intraoperative
Adverse events
Measured: Intraop and Postop
VAS Spine Score
Measured: 3 days and 6 weeks
VAS pain score
Measured: 3 days and 6 weeks
accompanying pain medication (or "self medication")
Measured: 6 weeks
patient satisfaction with operational results
The patient is asked the question whether he is satisfied with the results of the operation, he has the choice between six answers: very satisfied, satisfied, partly satisfied, unsatisfied, no comment
Measured: 6 weeks
Hospital length of stay
Measured: discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionOct 2014
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic FractureStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans Goost, MD, Principal investigator, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810094
- Sponsor's protocol ID
- AAG-O-H-0910
- Acronym
- FRIFIX
- Status last verified
- Jan 2017
- First submitted
- 26 Feb 2013
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Minimally Invasive Fixation of Thoracolumbar Fractures With the Fracture Fixation System S4, Performed With the Fracture Reduction Instrumentation FRI (FRIFIX)
- ClinicalTrials.gov ID
- NCT01810094
- Acronym / sponsor ID
- FRIFIX / AAG-O-H-0910
- Conditions
- Thoracic Fracture, Lumbar Fracture
- Keywords
- thoracolumbar fracture, fixation, fixateur interne, minimal invasive, percutaneous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2013 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 13 Mar 2013 (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.
Spinal injuries, such as vertebral fractures, often result in a significant instability of the spine and lead to acute or delayed neurological deficits. Depending on the type of injury there are various methods available to stabilize the spine. The proposed study should clarify whether the combined reduction and fixation with a minimally invasive approach can actually be done with the same precision as in a conventional approach. The primary endpoint of this investigation is the monosegmental anterior wedge angle (AWA), and its maintenance over the first 6 postoperative weeks. It is the aim of the study to gather key radiological, clinical and subjective patient outcome parameters for its patient population that will allow to compare the results to a historical group of patients. The study design is non-interventional, prospective, open,and multicentric.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive Approach | – | Device: Fracture FixationPatients with a thoracolumbar Fracture A3.1 to A 3.3 treated by fracture fixation by a minimally invasive approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (5 listed)
- Minimum age of the patients of 18 years
- Indication for operative treatment of fractures of the thoracic or lumbar spine
- Singular A3.1-3 fractures according to the AO classification system
- Declaration of consent in participation in this study and willingness to the treatment according to the study protocol
- Physical and mental ability to meet the clinical and radiological follow-up plan
Key exclusion criteria (11 listed)
- Additional severe trauma, that makes survey of the patient difficult or impossible influence the results of the fracture treatment significantly
- Additional trauma or fractures of the spine
- Other serious conditions complicating participation in the study
- Systemic or local infections
- Pregnancy or planned pregnancy
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 |
|---|---|---|
| Fracture FixationThoracolumbar Fracture Fixation | Device | Minimally invasive Approach |
Primary outcome
Anterior wedge angle (AWA)
Time frame: 6 weeks
8 secondary outcomes
Blood loss of the patient during surgery to stabilize the spine fracture
Time frame: intraoperative
OP duration
Time frame: intraoperative
Adverse events
Time frame: Intraop and Postop
VAS Spine Score
Time frame: 3 days and 6 weeks
VAS pain score
Time frame: 3 days and 6 weeks
accompanying pain medication (or "self medication")
Time frame: 6 weeks
patient satisfaction with operational results
Time frame: 6 weeks
Hospital length of stay
Time frame: discharge
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 26 Jan 2017.
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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.
Hans Goost, MD principal investigator
University Hospital, Bonn
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Fracture and Lumbar Fracture, run by Aesculap AG at 4 sites in Germany.
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 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 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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?
Anterior wedge angle (AWA) (time frame: 6 weeks). 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 26 Jan 2017.