Spine Registry University Hospital of Cologne- Department... | NCT05486494

Studies
Spine Registry University Hospital of Cologne- Department of Orthopedics

NCT05486494

Sponsor

University of Cologne

Status

Completed

Last Update Posted

Aug 3, 2022Actual

Enrollment

355Actual

Phase

Not provided

Conditions

Outcome, Fatal
Spondylodiscitis
Vertebral Osteomyelitis

Interventions

Treatment (non- surgical/surgical)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2008Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Aug 1, 2022

First Submission Date that Met QC Criteria

Aug 1, 2022

First Posted Date

Aug 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2022

Last Update Posted Date

Aug 3, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

355Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treatment (non- surgical/surgical)	Other	Treatment Outcome based on different aspects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of Life Data after surgery	Definition of Thresholds	2008- 2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Spine disease

Exclusion Criteria:

younger than 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ayla Yagdiran, M.D.	University of Cologne	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

none of the data are shared

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015299	Discitis
D012008	Recurrence

Ancestor Terms

ID	Term
D013166	Spondylitis
D001850	Bone Diseases, Infectious
D007239	Infections
D001847	Bone Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013812	Therapeutics
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided