Outcome, FatalNCT05486494
Spine Registry University Hospital of Cologne- Department of Orthopedics
An observational study of Outcome, Fatal and Spondylodiscitis, run by University of Cologne.
Trial summary
Between January 2008 and December 2020 all patients with spine diseases were registered prospectively in the former European Spine Tango registry and later german DWG registry at the department of orthopedics and trauma at the university of cologne. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Outcome, Fatal, Spondylodiscitis, Vertebral Osteomyelitis
- What is being tested?
- Treatment (non- surgical/surgical)
- How many people
- 355 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 31 Dec 2020
- How long will I take part?
- 2 Years
- 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: Within all patients spondylodiscitis/ vertebral osteomyelitis patients were analyzed in detail.
Who may be able to join
- Spine disease
Who cannot join
- younger than 18 years
About this study
Official title: Former Spine Tango Registry Now DWG Registry
Between January 2008 and December 2020 all patients with spine diseases were registered prospectively in the former European Spine Tango registry and later german DWG registry at the department of orthopedics and trauma at the university of cologne.
Read the detailed description
The following data were prospectively collected after enrollment: age, sex, body mass index (BMI), length of hospital stay, affected spine segment, previous surgical procedures on the spine, conservative or operative treatment including type of surgical treatment and American Society of Anesthesiologists (ASA) Physical Status Classification System.
In addition the following quality of life scores were collected: Oswestry Disability Score (ODI), Core Outcome Measures Index(COMI), Short Form- 36 (SF- 36) and Euroqol- 5D (EQ- 5D).
- Conditions
- Outcome, Fatal, Spondylodiscitis, Vertebral Osteomyelitis
- Being tested
- Treatment (non- surgical/surgical)
- Keywords
- Quality of Life, Treatment Failure, Relapse, Spondylodiscitis, Vertebral Osteomyelitis
- Medical subject headings
- Discitis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment (non- surgical/surgical)Other
Treatment Outcome based on different aspects
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Data after surgery
Definition of Thresholds
Measured: 2008- 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Jan 2008
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outcome, FatalStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 355 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayla Yagdiran, University of Cologne
- Investigators
- Ayla Yagdiran, M.D., Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486494
- Sponsor's protocol ID
- 09-182
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: none of the data are shared
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Former Spine Tango Registry Now DWG Registry
- ClinicalTrials.gov ID
- NCT05486494
- Acronym / sponsor ID
- 09-182
- Conditions
- Outcome, Fatal, Spondylodiscitis, Vertebral Osteomyelitis
- Keywords
- Quality of Life, Treatment Failure, Relapse, Spondylodiscitis, Vertebral Osteomyelitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 3 Aug 2022 (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.
Between January 2008 and December 2020 all patients with spine diseases were registered prospectively in the former European Spine Tango registry and later german DWG registry at the department of orthopedics and trauma at the university of cologne.
Detailed description
The following data were prospectively collected after enrollment: age, sex, body mass index (BMI), length of hospital stay, affected spine segment, previous surgical procedures on the spine, conservative or operative treatment including type of surgical treatment and American Society of Anesthesiologists (ASA) Physical Status Classification System.
In addition the following quality of life scores were collected: Oswestry Disability Score (ODI), Core Outcome Measures Index(COMI), Short Form- 36 (SF- 36) and Euroqol- 5D (EQ- 5D).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Within all patients spondylodiscitis/ vertebral osteomyelitis patients were analyzed in detail.
Key inclusion criteria (1 listed)
- Spine disease
Key exclusion criteria (1 listed)
- younger than 18 years
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 |
|---|---|---|
| Treatment (non- surgical/surgical)Treatment Outcome based on different aspects | Other | – |
Primary outcome
Quality of Life Data after surgery
Time frame: 2008- 2020
Definition of Thresholds
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 3 Aug 2022.
- Individual participant dataSharing planned: No. none of the data are shared
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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.
Ayla Yagdiran, M.D. principal investigator
University of Cologne
Questions about this trial
What is this clinical trial studying?
An observational study of Outcome, Fatal and Spondylodiscitis, run by University of Cologne.
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 1 inclusion and 1 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 3 Aug 2022. 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?
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?
Quality of Life Data after surgery (time frame: 2008- 2020). 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 3 Aug 2022.