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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04477447
Other study ID # AAG-O-H-2004
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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