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Completed

NCT Number: NCT04477447

PMCF Study on the Safety and Performance of CESPACE 3D

Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not interventional, multicenter)

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Key information

Conditions

Degenerative Instability Bone Diseases Musculoskeletal Diseases Post-discectomy Syndrome Post-traumatic Instabilities Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Katholisches Klinikum Koblenz, Koblenz, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is minimum 18 years old
  • Written informed consent for the documentation of clinical and radiological results
  • Patient's indication according to IFU
  • Patient is not pregnant

Exclusion criteria

  • Patient is not willing or able to participate at the follow-up examination

Treatment and study plan

Primary outcomes

  1. Change of Neck Specific Disability measured by Neck Disability Index (NDI)

    Time frame: preoperative, 12 months postoperative

    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. JOA score

    Time frame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively

    The Japanese Orthopaedic Association (JOA) score is a widely used tool to assess the severity of clinical symptoms in patients with cervical compressive myelopathy. Motor function (Upper extremity/Lower extremity); Sensory (Upper extremity/lower extremity/trunk); Bladder function. The Score reaches a maximum of 17 and a Minimum of 0 points.

  2. Pain (VAS)

    Time frame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively

    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.

  3. development of EQ-5D-5L

    Time frame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively

    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. development of radiological outcome

    Time frame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively

    if provided in the clinical standard; e.g. fusion, implant subsidence, implant migration)

  5. Rate of AE/SAEs

    Time frame: preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively

    Rate of AE/SAEs during the postoperative course

  6. Patient Satisfaction with Treatment Outcome

    Time frame: at one follow-up- assessment after a minimum of one year postoperatively

    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)

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

Multicenter PMCF Study on the Safety and Performance of CESPACE 3D - A Prospective Study on Total Indications

Acronym: CATALINA

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jul 20, 2020
Registry last updated
Dec 19, 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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