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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Spondylolisthesis; Degenerative Instability; Post-discectomy Syndrome; Post-traumatic Instabilities

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

• Study Type: Observational
• Enrollment (Actual): 208

Contacts and Locations

• Study Contact: Name: Stefan Maenz, Dr.; Phone Number: +49-7461-95-0; Email: stefan.maenz@aesculap.de

Study Locations

• Germany
  • Koblenz, Germany, 56073
    • Katholisches Klinikum Koblenz
  • Kremmen, Germany, 16766
    • Sana Kliniken Sommerfeld

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All Patients undergoing PROSPACE 3D, PROSPACE 3D OBLIQUE or TSPACE 3D surgery in the participating Hospitals meeting the inclusion criteria are included in the study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aesculap AG

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Actual): January 9, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Lumbar interbody Fusion; Intervertebral Implant
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: AAG-O-H-2003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No