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

Aesculap AG208 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

208

Conditions

Degenerative Instability Spondylolisthesis Post-discectomy Syndrome Post-traumatic Instabilities

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Katholisches Klinikum Koblenz

Koblenz, Germany

Sana Kliniken Sommerfeld

Kremmen, Germany

Outcomes

Primary Outcomes

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.

Time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively

Secondary Outcomes

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"

Time frame: 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.

Time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively

Bone fusion

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.