Quintex® Follow-up After One Year Minimum

Trauma Clinical Trial

— Quintex  

Official title:

Prospective Follow-up Study of the Aesculap Quintex® Anterior Cervical Plating System After a Minimum of One Year

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04489394
• Other study ID #: AAG-O-H-1901
• Status: Completed
• Start date: November 11, 2019
• Est. completion date: February 18, 2020

Study information

• Verified date: April 2024
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 18, 2020
• Est. primary completion date: February 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient informed consent not signed
• Patients living outside a radius of 80 km around the study center

Related Conditions & MeSH terms

• Cervical Spondylosis
• Deformity of Spine
• Degenerative Disc Disease
• Instability; Back
• Intervertebral Disc Degeneration
• Pseudarthrosis
• Pseudoarthrosis of Spine
• Spinal Stenosis
• Spondylolisthesis
• Spondylosis
• Trauma

Locations

Country	Name	City	State
Germany	Katholisches Klinikum Koblenz	Koblenz

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neck and arm pain	Visual analogue scale for pain: The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain ever with a frowning face image.	One retrospective visit, between one and approx. five years post-op.
Secondary	Patient satisfaction	Patient satisfaction with Outcome of surgery documented in two aspects: is the Patient satisfied (four Point scale: very satisfied, satisfied, unsatisfied, very unsatisfied) and would the Patient like to undergo surgery again (yes, no, not willing to say)	One retrospective visit, between one and approx. five years post-op.
Secondary	Quality of life measured by EQ-5D-5L	The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/ depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	One retrospective visit, between one and approx. five years post-op.
Secondary	Dysphagia assessment	Bazaz score: The Bazaz Dysphagia Score is one criterion used to define dysphagia; it classifies dysphagia as severe, moderate, mild, or none	One retrospective visit, between one and approx. five years post-op.
Secondary	Complications	Adverse Events and Serious Adverse Events, reoperations and revisions rates	One retrospective visit, between one and approx. five years post-op.
Secondary	Postoperative Need for Pain medication	The patient's Need for Pain Medication is measured by the WHO (World Health Organization) analgesic ladder	One retrospective visit, between one and approx. five years post-op.
Secondary	Radiological outcome from standard x-rays	Radiologically: Fusion status, plate position, pot. migration of screws and plate, radiolucent lines	One retrospective visit, between one and approx. five years post-op.