Multicenter PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D - A Prospective Study on Total Indications
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Degenerative Instability
- Sponsor
- Aesculap AG
- Enrollment
- 208
- Locations
- 2
- Primary Endpoint
- Change of Spinal Disability measured by Oswestry Disability Index (ODI)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Prospective, pure data collection of all PROSPACE 3D, PROSPACE 3D Oblique, TSPACE 3D patients in selected centers (not interventional, multicenter
Detailed Description
The study collects a data set for each patient receiving a PROSPACE 3D, PROSPACE 3D Oblique, or TSPACE 3D implant. It is intended to collect data preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively containing * Basic medical history * Type of surgical procedure * Treated segments * Implant characteristics (including additional implants for anterior/posterior stabilization) * Scores: ODI, Pain (VAS), EQ-5D * Patient satisfaction
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change of Spinal Disability measured by Oswestry Disability Index (ODI)
Time Frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
The Oswestry Disability Index (ODI) is designed to measure back-specific disability. The questionnaire has 10 items concerning pain and activities of daily living including pain, personal care, lifting, Walking, sitting, standing, sleeping, sex life, social life and travelling. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Secondary Outcomes
- Side effects(up to 12 months postoperatively)
- Change of Quality of Life (EQ-5D)(preoperatively, at 3 months postoperatively and at 12 months postoperatively)
- Change of Pain (VAS)(preoperatively, at 3 months postoperatively and at 12 months postoperatively)
- Bone fusion(12 Months postoperatively)