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CompletedNCT05486494Updated Aug 3, 2022

Spine Registry University Hospital of Cologne- Department of Orthopedics

An observational study in Outcome, Fatal, Spondylodiscitis and Vertebral Osteomyelitis, sponsored by University of Cologne. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-03.

Sponsored by University of Cologne · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
355
Ages
18 Years and older
Sex
All
01

Study 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 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).

02

Conditions studied

  • Outcome, Fatal
  • Spondylodiscitis
  • Vertebral Osteomyelitis

Keywords

  • Quality of Life, Treatment Failure, Relapse, Spondylodiscitis, Vertebral Osteomyelitis
03

In context

Discitis

24 studies on the registry are indexed under Discitis; 5 are open to participants now.

This study's enrollment of 355 is above the median of 104 across 16 observational studies indexed under Discitis.

Browse Discitis studies →

Lead sponsor

University of Cologne is the lead sponsor of 203 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Within all patients spondylodiscitis/ vertebral osteomyelitis patients were analyzed in detail.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Spine disease

Exclusion criteria

Exclusion Criteria:

  • younger than 18 years
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
355 participants (actual)
Target follow-up
2 Years
Patient registry
Yes

Interventions

  • OtherTreatment (non- surgical/surgical)

    Treatment Outcome based on different aspects

06

What researchers measure

Primary outcomes

  1. Quality of Life Data after surgery

    Definition of Thresholds

    Time frame: 2008- 2020

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — none of the data are shared

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2008 to primary completion in Dec 2020, 155 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2022
First posted
Aug 3, 2022
StartActual
Jan 1, 2008
Primary completionActual
Dec 31, 2020
CompletionActual
Dec 31, 2020
Last update
Aug 3, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05486494
Responsible party
Ayla Yagdiran (Senior Consultant, University of Cologne) — Principal investigator
First posted
Aug 3, 2022
Start date
Jan 1, 2008
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Aug 3, 2022

Study contacts

Ayla Yagdiran, M.D.
principal investigator · University of Cologne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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