- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04542577
PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D (PROTONTO)
June 21, 2024 updated by: Aesculap AG
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Koblenz, Germany, 56073
- Katholisches Klinikum Koblenz
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Kremmen, Germany, 16766
- Sana Kliniken Sommerfeld
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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)
Time Frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
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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.
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preoperatively, at 3 months postoperatively and at 12 months postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Pain (VAS)
Time Frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
|
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"
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preoperatively, at 3 months postoperatively and at 12 months postoperatively
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Change of Quality of Life (EQ-5D)
Time Frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
|
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.
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preoperatively, at 3 months postoperatively and at 12 months postoperatively
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Bone fusion
Time Frame: 12 Months postoperatively
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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.
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12 Months postoperatively
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Side effects
Time Frame: up to 12 months postoperatively
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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.
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up to 12 months postoperatively
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 23, 2020
Primary Completion (Actual)
January 9, 2023
Study Completion (Estimated)
August 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)
June 24, 2024
Last Update Submitted That Met QC Criteria
June 21, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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