PMCF Study on the Safety and Performance of CESPACE 3D

Spondylolisthesis Clinical Trial

— CATALINA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04477447
• Other study ID #: AAG-O-H-2004
• Status: Recruiting
• Start date: September 21, 2020
• Est. completion date: June 2024

Study information

• Verified date: January 2023
• Source: Aesculap AG
• Contact: Stefan Maenz, Dr.
• Phone: +49-7461-95-0
• Email: stefan.maenz[@]aesculap.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Instability
• Post-discectomy Syndrome
• Post-traumatic Instabilities
• Spondylolisthesis

Locations

Country	Name	City	State
Germany	Katholisches Klinikum Koblenz	Koblenz
Germany	Sana Kliniken Sommerfeld	Kremmen

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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