Degenerative InstabilityPROTONTONCT04542577
PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D
An observational study of Degenerative Instability and Spondylolisthesis, run by Aesculap AG at 2 sites in Germany.
Trial summary
Prospective, pure data collection of all PROSPACE 3D, PROSPACE 3D Oblique, TSPACE 3D patients in selected centers (not interventional, multicenter Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome
- How many people
- 208 participants
- Where
- 2 sitesGermany
- Study dates
- 23 Sep 2020to 25 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patient is not willing or able to participate at the follow-up examination
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Katholisches Klinikum Koblenz
Koblenz, 56073
Sana Kliniken Sommerfeld
Kremmen, 16766
About this study
Official title: 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
Read the 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
- Conditions
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instabilities
- Keywords
- Lumbar interbody Fusion, Intervertebral Implant
- Medical subject headings
- Spondylolisthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: preoperatively, at 3 months postoperatively and at 12 months postoperatively
Secondary outcomes (4)
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"
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start23 Sep 2020
- Primary completion9 Jan 2023
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative InstabilityStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542577
- Sponsor's protocol ID
- AAG-O-H-2003
- Acronym
- PROTONTO
- Status last verified
- Dec 2024
- First submitted
- 2 Sep 2020
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D - A Prospective Study on Total Indications
- ClinicalTrials.gov ID
- NCT04542577
- Acronym / sponsor ID
- PROTONTO / AAG-O-H-2003
- Conditions
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instabilities
- Keywords
- Lumbar interbody Fusion, Intervertebral Implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, pure data collection of all PROSPACE 3D, PROSPACE 3D Oblique, TSPACE 3D patients in selected centers (not interventional, multicenter
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patient is not willing or able to participate at the follow-up examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of Spinal Disability measured by Oswestry Disability Index (ODI)
Time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
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.
4 secondary outcomes
Change of Pain (VAS)
Time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
Change of Quality of Life (EQ-5D)
Time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
Bone fusion
Time frame: 12 Months postoperatively
Side effects
Time frame: up to 12 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
Related trials for Degenerative Instability
RecruitingPhase 1/2
Stimulation-based Therapy to Improve Balance in DCM
Degenerative Cervical Myelopathy
RecruitingObservational study
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
Spine Fracture, Degenerative Disc Disease
Recruiting
Clinical Outcomes Study of the Nexel Total Elbow
Elbow Joint Destruction, Post-traumatic Lesions
Not yet recruitingObservational study
Role of Intraoperative Computed Tomography in Assessment of Spine Instability in Lumbar Degenerative Disease
Degenerative Lumbar Spine Diseases, Lumbar Spinal Instability
Recruiting
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Lumbar Spine Degeneration, Lumbar Spine Instability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Instability and Spondylolisthesis, run by Aesculap AG at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Spinal Disability measured by Oswestry Disability Index (ODI) (time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.