PMCF Study on the Safety and Performance of CESPACE 3D

Browse trials for

• Spondylolisthesis 237

Keywords

• Cervical Vertebrae;
• Spondylolisthesis;
• Treatment Outcome;
• Interbody Fusion

Spondylolisthesis

237 studies on the registry are indexed under Spondylolisthesis; 47 are open to participants now.

This study's enrollment of 101 is below the median of 121 across 80 observational studies indexed under Spondylolisthesis.

Lead sponsor

Aesculap AG is the lead sponsor of 104 studies on the registry; 20 are open to participants now.

Study population

Primary outcomes

1. 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

1. 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

2. 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

3. 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.

   Time frame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively

4. development of radiological outcome

   if provided in the clinical standard; e.g. fusion, implant subsidence, implant migration)

   Time frame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively

5. Rate of AE/SAEs

   Rate of AE/SAEs during the postoperative course

   Time frame: preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively

6. 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)

   Time frame: at one follow-up- assessment after a minimum of one year postoperatively