PMCF Study on the Safety and Performance of CESPACE 3D

N/ACompletedNCT04477447

Aesculap AG101 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

101

Conditions

Degenerative Instability Spondylolisthesis Post-discectomy Syndrome Post-traumatic Instabilities

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Katholisches Klinikum Koblenz

Koblenz, Germany

Sana Kliniken Sommerfeld

Kremmen, Germany

Outcomes

Primary Outcomes

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.

Time frame: preoperative, 12 months postoperative

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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