Quintex® Follow-up After One Year Minimum
Quintex
Prospective Follow-up Study of the Aesculap Quintex® Anterior Cervical Plating System After a Minimum of One Year
1 other identifier
observational
60
1 country
1
Brief Summary
Prospective study, not randomised, non-interventional, monocentric, investigating an intended patient cohort of 60 patients already operated on the cervical spine due to degenerative disc disease of the cervical spine down to the first thoracolumbar VBR (C2-T1), who received a Quintex plate for stabilisation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2020
CompletedFirst Submitted
Initial submission to the registry
July 24, 2020
CompletedFirst Posted
Study publicly available on registry
July 28, 2020
CompletedApril 9, 2024
April 1, 2024
3 months
July 24, 2020
April 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Results 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.
One retrospective visit, between one and approx. five years post-op.
Secondary Outcomes (7)
Neck and arm pain
One retrospective visit, between one and approx. five years post-op.
Patient satisfaction
One retrospective visit, between one and approx. five years post-op.
Quality of life measured by EQ-5D-5L
One retrospective visit, between one and approx. five years post-op.
Dysphagia assessment
One retrospective visit, between one and approx. five years post-op.
Complications
One retrospective visit, between one and approx. five years post-op.
- +2 more secondary outcomes
Eligibility Criteria
adult patients
You may qualify if:
- \- all patients who received a Quintex® Anterior Cervical Plate since 2014 until approx. end 2018 (minimum Follow-up is one year) in the study center
You may not qualify if:
- Patient informed consent not signed
- Patients living outside a radius of 80 km around the study center
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aesculap AGlead
Study Sites (1)
Katholisches Klinikum Koblenz
Koblenz, 56073, Germany
Related Publications (1)
Bruchmann B, Kilian F. Follow-up of a new titanium cervical plate for fusion of the cervical spine. Orthop Rev (Pavia). 2023 Oct 12;15:84651. doi: 10.52965/001c.84651. eCollection 2023.
PMID: 37842541RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2020
First Posted
July 28, 2020
Study Start
November 11, 2019
Primary Completion
February 18, 2020
Study Completion
February 18, 2020
Last Updated
April 9, 2024
Record last verified: 2024-04