PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D

Study Overview
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Brief Summary
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Prospective, pure data collection of all PROSPACE 3D, PROSPACE 3D Oblique, TSPACE 3D patients in selected centers (not interventional, multicenter

Detailed Description
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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

Official Title
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Multicenter PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D - A Prospective Study on Total Indications

Conditions
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Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instabilities

Participation Criteria
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Eligibility Criteria
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Inclusion: 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: - Patient is not willing or able to participate at the follow-up examination

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Spinal Disability measured by Oswestry Disability Index (ODI) | 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. | preoperatively, at 3 months postoperatively and at 12 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pain (VAS) | Pain will be assessed by the patient using the Visual Analogue Scale (VAS) which state 0 at one end representing no pain and 100 at the opposite end representing maximal/worst pain | preoperatively, at 3 months postoperatively and at 12 months postoperatively | 
| Change of Quality of Life (EQ-5D) | The score is self-completion by the patient and will therefore be used in German. The Quality of Life Score EQ-5D is a standardized 5-dimension 5-level measure of the health status and is developed by the EuroQol Group in order to have a simple and generic measure for clinical and economic assessment. 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, at 3 months postoperatively and at 12 months postoperatively | 
| Bone fusion | After IBF surgery fusion of the treated segment is aspired. Thus, the implant design shall allow on-/ingrowth to/into the material. The fusion status can be determined from radiographs (static or dynamic). Bony fusion can be characterized quantitatively by the fusion rate. | 12 Months postoperatively | 
| Side effects | Occurrence of complications potentially associated with the implanted devices can never be fully excluded during spinal surgery. In order to monitor potential complication and to identify so far unknown complications AEs and SAEs deemed related to the investigational device are recorded. | up to 12 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar interbody Fusion, Intervertebral Implant