Spine FractureNCT07847320
Controlled Reduction of AO Spine B3 Fractures in Ankylosing Spinal Disorders Using an Inflatable Positioning Device: Technical Note and Retrospective Single-centre Case Series
An observational study of Spine Fracture and Osteoporosis, run by Diakonie-Klinikum Stuttgart.
Trial summary
Retrospective observational Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Fracture, Osteoporosis, Spondylitis, Ankylosing
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 20 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 ankylozing spondylitis and B3 spine fractures
Who may be able to join
- Patients were eligible if they were aged 18 years or older
- Had a documented diagnosis of ankylosing spondylitis
- Had an imaging-confirmed AO Spine B3 fracture,
- Underwent posterior instrumented stabilization.
Who cannot join
- Patients managed non-operatively
- Patients with spondylodiscitis, primary or metastatic neoplasia, or congenital spinal anomalies were excluded.
- Patients with insufficient data for the predefined variables or without follow-up to the primary endpoint were excluded
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Controlled Reduction of Thoracolumbar AO Spine B3 Fractures in Ankylosing Spinal Disorders Using an Inflatable Positioning Device: Technical Note and Retrospective Single-centre Case Series
Retrospective observational
Read the detailed description
Retrospective observational study of B3 spine fractures
- Conditions
- Spine Fracture, Osteoporosis, Spondylitis, Ankylosing
- Keywords
- B3 fractures, spine fractures
- Medical subject headings
- Spinal Fractures, Osteoporosis, Spondylitis, Ankylosing
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Clavien-Dindo classification for complications
Measured: 12 months
Secondary outcomes (1)
Hardware related complications
Complications like screw losening, screw fracture, etc
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion20 Sep 2026
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spine 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonie-Klinikum Stuttgart
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847320
- Sponsor's protocol ID
- IRB_03_2026 and IRB_005_2026
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kohler FC, Schenk P, Bechstedt-Schimske M, Ullrich BW, Klauke F, Hofmann GO, Mendel T. Open versus minimally invasive fixation of thoracic and lumbar spine fractures in patients with ankylosing spinal diseases. Eur J Trauma Emerg Surg. 2022 Jun;48(3):2297-2307. doi: 10.1007/s00068-021-01756-3. Epub 2021 Aug 6.
PubMed 34357408Westerveld LA, van Bemmel JC, Dhert WJ, Oner FC, Verlaan JJ. Clinical outcome after traumatic spinal fractures in patients with ankylosing spinal disorders compared with control patients. Spine J. 2014 May 1;14(5):729-40. doi: 10.1016/j.spinee.2013.06.038. Epub 2013 Aug 27.
PubMed 23992936
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Reduction of Thoracolumbar AO Spine B3 Fractures in Ankylosing Spinal Disorders Using an Inflatable Positioning Device: Technical Note and Retrospective Single-centre Case Series
- ClinicalTrials.gov ID
- NCT07847320
- Acronym / sponsor ID
- IRB_03_2026 and IRB_005_2026
- Conditions
- Spine Fracture, Osteoporosis, Spondylitis, Ankylosing
- Keywords
- B3 fractures, spine fractures
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Diakonie-Klinikum StuttgartUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 20 Sep 2026 (actual)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 29 Sep 2026 (actual)
- 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.
Retrospective observational
Detailed description
Retrospective observational study of B3 spine fractures
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ankylozing spondylitis and B3 spine fractures
Key inclusion criteria (4 listed)
- Patients were eligible if they were aged 18 years or older
- Had a documented diagnosis of ankylosing spondylitis
- Had an imaging-confirmed AO Spine B3 fracture,
- Underwent posterior instrumented stabilization.
Key exclusion criteria (3 listed)
- Patients managed non-operatively
- Patients with spondylodiscitis, primary or metastatic neoplasia, or congenital spinal anomalies were excluded.
- Patients with insufficient data for the predefined variables or without follow-up to the primary endpoint were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complications
Time frame: 12 months
Clavien-Dindo classification for complications
1 secondary outcome
Hardware related complications
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 34357408Kohler FC, Schenk P, Bechstedt-Schimske M, Ullrich BW, Klauke F, Hofmann GO, Mendel T. Open versus minimally invasive fixation of thoracic and lumbar spine fractures in patients with ankylosing spinal diseases. Eur J Trauma Emerg Surg. 2022 Jun;48(3):2297-2307. doi: 10.1007/s00068-021-01756-3. Epub 2021 Aug 6.
- Background: PubMed 23992936Westerveld LA, van Bemmel JC, Dhert WJ, Oner FC, Verlaan JJ. Clinical outcome after traumatic spinal fractures in patients with ankylosing spinal disorders compared with control patients. Spine J. 2014 May 1;14(5):729-40. doi: 10.1016/j.spinee.2013.06.038. Epub 2013 Aug 27.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Fracture and Osteoporosis, run by Diakonie-Klinikum Stuttgart.
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 3 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edgar Santos, PD. Dr. med (+4917661510746, edgar.santos@diak-stuttgart.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: 12 months). 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 NCT07847320, which also lists 2 linked publications.
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 29 Sep 2026.