- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07847320
Controlled Reduction of AO Spine B3 Fractures in Ankylosing Spinal Disorders Using an Inflatable Positioning Device: Technical Note and Retrospective Single-centre Case Series
September 23, 2026 updated by: Diakonie-Klinikum Stuttgart
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
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Retrospective observational study of B3 spine fractures
Study Type
Observational
Enrollment (Estimated)
23
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Edgar Santos, PD. Dr. med
- Phone Number: +4917661510746
- Email: edgar.santos@diak-stuttgart.de
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with ankylozing spondylitis and B3 spine fractures
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: CASE_ONLY
- Time Perspectives: RETROSPECTIVE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complications
Time Frame: 12 months
|
Clavien-Dindo classification for complications |
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hardware related complications
Time Frame: 12 months
|
Complications like screw losening, screw fracture, etc |
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Westerveld 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 20, 2026
Primary Completion (Actual)
September 20, 2026
Study Completion (Estimated)
September 20, 2026
Study Registration Dates
First Submitted
September 23, 2026
First Submitted That Met QC Criteria
September 23, 2026
First Posted (Actual)
September 29, 2026
Study Record Updates
Last Update Posted (Actual)
September 29, 2026
Last Update Submitted That Met QC Criteria
September 23, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Axial Spondyloarthritis
- Bone Diseases
- Musculoskeletal Diseases
- Wounds and Injuries
- Arthritis
- Joint Diseases
- Metabolic Diseases
- Spinal Diseases
- Spondylarthropathies
- Ankylosis
- Fractures, Bone
- Bone Diseases, Metabolic
- Spondylarthritis
- Spondylitis
- Back Injuries
- Spinal Injuries
- Nutritional and Metabolic Diseases
- Spondylitis, Ankylosing
- Osteoporosis
- Spinal Fractures
Other Study ID Numbers
- IRB_03_2026 and IRB_005_2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.