Spine Registry University Hospital of Cologne- Department of Orthopedics

• Sponsor: University of Cologne (Other)
• Overall Status: Completed
• CT.gov ID: NCT05486494
• Collaborator: (none)
• Enrollment: 355
• Actual Duration (Months): 156

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Outcome, Fatal; Spondylodiscitis; Vertebral Osteomyelitis	Other: Treatment (non- surgical/surgical)

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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 355 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Former Spine Tango Registry Now DWG Registry
• Actual Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Outcome Measures

Primary Outcome Measures

1. Quality of Life Data after surgery [2008- 2020]

   Definition of Thresholds

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Spine disease

Exclusion Criteria:

• younger than 18 years

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Cologne

Investigators

• Principal Investigator: Ayla Yagdiran, M.D., University of Cologne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ayla Yagdiran, Senior Consultant, University of Cologne
• ClinicalTrials.gov Identifier: NCT05486494
• Other Study ID Numbers: 09-182
• First Posted: Aug 3, 2022
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ayla Yagdiran, Senior Consultant, University of Cologne: Quality of Life, Treatment Failure, Relapse, Spondylodiscitis, Vertebral Osteomyelitis
• Additional relevant MeSH terms: Osteomyelitis; Discitis

Study Results

No Results Posted as of Aug 3, 2022