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

Aesculap AG2 sites in 1 country101 target enrollmentSeptember 21, 2020

ConditionsDegenerative Instability Spondylolisthesis Post-discectomy Syndrome Post-traumatic Instabilities

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Degenerative Instability
Sponsor: Aesculap AG
Enrollment: 101
Locations: 2
Primary Endpoint: Change of Neck Specific Disability measured by Neck Disability Index (NDI)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 21, 2020

End Date

April 16, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Aesculap AG

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

JOA score(preoperatively and at one follow-up- assessment after a minimum of one year postoperatively)
Pain (VAS)(preoperatively and at one follow-up- assessment after a minimum of one year postoperatively)
development of EQ-5D-5L(preoperatively and at one follow-up- assessment after a minimum of one year postoperatively)
development of radiological outcome(preoperatively and at one follow-up- assessment after a minimum of one year postoperatively)
Rate of AE/SAEs(preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively)
Patient Satisfaction with Treatment Outcome(at one follow-up- assessment after a minimum of one year postoperatively)