PMCF Study on the Safety and Performance of CESPACE 3D
CATALINA
Multicenter PMCF Study on the Safety and Performance of CESPACE 3D - A Prospective Study on Total Indications
1 other identifier
observational
101
1 country
2
Brief Summary
Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not interventional, multicenter)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2020
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2020
CompletedFirst Posted
Study publicly available on registry
July 20, 2020
CompletedStudy Start
First participant enrolled
September 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2024
CompletedDecember 19, 2024
December 1, 2024
2.7 years
July 10, 2020
December 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of Neck Specific Disability measured by Neck Disability Index (NDI)
The NDI is designed to measure neck-specific disability. The questionnaire has 10 items to measure patient-reported disability secondary to neck pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation and patients rate their status from 0 (best) to 5 (worst imaginable). Individual item responses are summed to a total score, where 0 points indicate no activity limitations and 50 points indicate complete activity limitation.
preoperative, 12 months postoperative
Secondary Outcomes (6)
JOA score
preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
Pain (VAS)
preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
development of EQ-5D-5L
preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
development of radiological outcome
preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
Rate of AE/SAEs
preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively
- +1 more secondary outcomes
Eligibility Criteria
adult patients
You may qualify if:
- Patient is minimum 18 years old
- Written informed consent for the documentation of clinical and radiological results
- Patient's indication according to IFU
- Patient is not pregnant
You may not qualify if:
- Patient is not willing or able to participate at the follow-up examination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aesculap AGlead
Study Sites (2)
Katholisches Klinikum Koblenz
Koblenz, 56073, Germany
Sana Kliniken Sommerfeld
Kremmen, 16766, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Nikolaus Kroppenstedt, Dr. med.
Abteilung für Wirbelsäulenchirurgie Sana Kliniken Sommerfeld
- PRINCIPAL INVESTIGATOR
Francis Kilian, Dr. med.
Katholisches Klinikum Koblenz
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2020
First Posted
July 20, 2020
Study Start
September 21, 2020
Primary Completion
June 13, 2023
Study Completion
April 16, 2024
Last Updated
December 19, 2024
Record last verified: 2024-12