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Completed

NCT Number: NCT04489394

Quintex® Follow-up After One Year Minimum

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

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Cervical Spondylosis Deformity of Spine Instability; Back Intervertebral Disc Degeneration Musculoskeletal Diseases Pseudoarthrosis of Spine Spinal Diseases Spinal Stenosis Spondylolisthesis Spondylolysis Spondylosis Trauma Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Katholisches Klinikum Koblenz

Koblenz, 56073, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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

  5. Complications

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

    Adverse Events and Serious Adverse Events, reoperations and revisions rates

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

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

Acronym: Quintex

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 28, 2020
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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