Quintex® Follow-up After One Year Minimum (Quintex)

July 28, 2020 updated by: Aesculap AG

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

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

Study Overview

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Koblenz, Germany, 56073
        • Katholisches Klinikum Koblenz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Results measured by Neck Disability Index (NDI)
Time Frame: One retrospective visit, between one and approx. five years post-op.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck and arm pain
Time Frame: One retrospective visit, between one and approx. five years post-op.
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.
Patient satisfaction
Time Frame: One retrospective visit, between one and approx. five years post-op.

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.
Quality of life measured by EQ-5D-5L
Time Frame: One retrospective visit, between one and approx. five years post-op.
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.
Dysphagia assessment
Time Frame: One retrospective visit, between one and approx. five years post-op.
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.
Complications
Time Frame: One retrospective visit, between one and approx. five years post-op.
Adverse Events and Serious Adverse Events, reoperations and revisions rates
One retrospective visit, between one and approx. five years post-op.
Postoperative Need for Pain medication
Time Frame: One retrospective visit, between one and approx. five years post-op.
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.
Radiological outcome from standard x-rays
Time Frame: One retrospective visit, between one and approx. five years post-op.
Radiologically: Fusion status, plate position, pot. migration of screws and plate, radiolucent lines
One retrospective visit, between one and approx. five years post-op.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2019

Primary Completion (Actual)

February 18, 2020

Study Completion (Actual)

February 18, 2020

Study Registration Dates

First Submitted

July 24, 2020

First Submitted That Met QC Criteria

July 24, 2020

First Posted (Actual)

July 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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