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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05486494
Other study ID # 09-182
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2008
Est. completion date December 31, 2020

Study information

Verified date August 2022
Source University of Cologne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 355
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Spine disease Exclusion Criteria: - younger than 18 years

Study Design


Intervention

Other:
Treatment (non- surgical/surgical)
Treatment Outcome based on different aspects

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Cologne

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life Data after surgery Definition of Thresholds 2008- 2020
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