PMCF Study on the Safety and Performance of CESPACE 3D

Completed

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

• Registration Number: NCT04477447
• Lead Sponsor: Aesculap AG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-17
• Study First Posted: 2020-07-20
• Study Start: 2020-09-21
• Primary Completion: 2023-06-13
• Study Completion: 2024-04-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of Neck Specific Disability measured by Neck Disability Index (NDI)	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 Outcome Measures

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

Trial Locations

Locations (2)

Katholisches Klinikum Koblenz; 🇩🇪 Koblenz, Germany

Sana Kliniken Sommerfeld; 🇩🇪 Kremmen, Germany