Quintex® Follow-up After One Year Minimum

Completed

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

• Registration Number: NCT04489394
• Lead Sponsor: Aesculap AG

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-11
• Primary Completion: 2020-02-18
• Study Completion: 2020-02-18
• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Results measured by Neck Disability Index (NDI)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Katholisches Klinikum Koblenz; 🇩🇪 Koblenz, Germany