PMCF Study on the Safety and Performance of CESPACE 3D (CATALINA)

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

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

Study Overview

• Status: Recruiting
• Conditions: Spondylolisthesis; Degenerative Instability; Post-discectomy Syndrome; Post-traumatic Instabilities

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Stefan Maenz, Dr.; Phone Number: +49-7461-95-0; Email: stefan.maenz@aesculap.de

Study Locations

• Germany
  • Koblenz, Germany, 56073
    • Not yet recruiting
    • Katholisches Klinikum Koblenz
    • Contact: Francis Kilian, Dr. med.
    • Contact: Bernhard Bruchmann, Dr.
  • Kremmen, Germany, 16766
    • Recruiting
    • Sana Kliniken Sommerfeld
    • Principal Investigator: Stefan Nikolaus Kroppenstedt, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adult patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Neck Specific Disability 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.	preoperative, 12 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
JOA score	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.	preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
Pain (VAS)	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.	preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
development of 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.	preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
development of radiological outcome	if provided in the clinical standard; e.g. fusion, implant subsidence, implant migration)	preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
Rate of AE/SAEs	Rate of AE/SAEs during the postoperative course	preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively
Patient Satisfaction with Treatment Outcome	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)	at one follow-up- assessment after a minimum of one year postoperatively

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Stefan Nikolaus Kroppenstedt, Dr. med., Abteilung für Wirbelsäulenchirurgie Sana Kliniken Sommerfeld; Principal Investigator: Francis Kilian, Dr. med., Katholisches Klinikum Koblenz

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Interbody Fusion; Cervical Vertebrae;; Spondylolisthesis;; Treatment Outcome
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: AAG-O-H-2004