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

Spondylolisthesis Clinical Trial

— PROTONTO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04542577
• Other study ID #: AAG-O-H-2003
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Degenerative Instability
• Post-discectomy Syndrome
• Post-traumatic Instabilities
• Spondylolisthesis

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