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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04542577
Other study ID # AAG-O-H-2003
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 23, 2020
Est. completion date February 2024

Study information

Verified date April 2023
Source Aesculap AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 208
Est. completion date February 2024
Est. primary completion date January 9, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Germany Katholisches Klinikum Koblenz Koblenz
Germany Sana Kliniken Sommerfeld Kremmen

Sponsors (1)

Lead Sponsor Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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