Quintex® Follow-up After One Year Minimum

Aesculap AG60 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Katholisches Klinikum Koblenz

Koblenz, Germany

Outcomes

Primary Outcomes

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.

Time frame: One retrospective visit, between one and approx. five years post-op.

Secondary Outcomes

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.

Time frame: One retrospective visit, between one and approx. five years post-op.

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)

Time frame: One retrospective visit, between one and approx. five years post-op.

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.

Data from ClinicalTrials.gov

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