Degenerative InstabilityCATALINANCT04477447
PMCF Study on the Safety and Performance of CESPACE 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 CeSPACE 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
- 101 participants
- Where
- 2 sitesGermany
- Study dates
- 21 Sep 2020to 16 Apr 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: adult patients
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 CESPACE 3D - A Prospective Study on Total Indications
Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not interventional, multicenter)
- Conditions
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instabilities
- Keywords
- Cervical Vertebrae;, Spondylolisthesis;, Treatment Outcome;, Interbody Fusion
- Medical subject headings
- Spondylolisthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Neck Specific Disability measured by Neck Disability Index (NDI)
The NDI is designed to measure neck-specific disability. The questionnaire has 10 items to measure patient-reported disability secondary to neck pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation and patients rate their status from 0 (best) to 5 (worst imaginable). Individual item responses are summed to a total score, where 0 points indicate no activity limitations and 50 points indicate complete activity limitation.
Measured: preoperative, 12 months postoperative
Secondary outcomes (6)
JOA score
The Japanese Orthopaedic Association (JOA) score is a widely used tool to assess the severity of clinical symptoms in patients with cervical compressive myelopathy. Motor function (Upper extremity/Lower extremity); Sensory (Upper extremity/lower extremity/trunk); Bladder function. The Score reaches a maximum of 17 and a Minimum of 0 points.
Measured: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
Pain (VAS)
The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain ever with a frowning face image.
Measured: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
development of EQ-5D-5L
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. 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 and at one follow-up- assessment after a minimum of one year postoperatively
development of radiological outcome
if provided in the clinical standard; e.g. fusion, implant subsidence, implant migration)
Measured: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
Rate of AE/SAEs
Rate of AE/SAEs during the postoperative course
Measured: preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively
Patient Satisfaction with Treatment Outcome
Patient satisfaction with Outcome of surgery documented in two aspects: is the Patient satisfied (four Point scale: very satisfied, satisfied, unsatisfied, very unsatisfied) and would the Patient like to undergo surgery again (yes, no, not willing to say)
Measured: at one follow-up- assessment after a minimum of one year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start21 Sep 2020
- Primary completion13 Jun 2023
- Study completion16 Apr 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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Nikolaus Kroppenstedt, Dr. med., Principal investigator, Abteilung für Wirbelsäulenchirurgie Sana Kliniken SommerfeldFrancis Kilian, Dr. med., Principal investigator, Katholisches Klinikum Koblenz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477447
- Sponsor's protocol ID
- AAG-O-H-2004
- Acronym
- CATALINA
- Status last verified
- Dec 2024
- First submitted
- 10 Jul 2020
- Last updated
- 19 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 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 CESPACE 3D - A Prospective Study on Total Indications
- ClinicalTrials.gov ID
- NCT04477447
- Acronym / sponsor ID
- CATALINA / AAG-O-H-2004
- Conditions
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instabilities
- Keywords
- Cervical Vertebrae;, Spondylolisthesis;, Treatment Outcome;, Interbody Fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 20 Jul 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 CeSPACE 3D patients in selected centers (not interventional, multicenter)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
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 Neck Specific Disability measured by Neck Disability Index (NDI)
Time frame: preoperative, 12 months postoperative
The NDI is designed to measure neck-specific disability. The questionnaire has 10 items to measure patient-reported disability secondary to neck pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation and patients rate their status from 0 (best) to 5 (worst imaginable). Individual item responses are summed to a total score, where 0 points indicate no activity limitations and 50 points indicate complete activity limitation.
6 secondary outcomes
JOA score
Time frame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
Pain (VAS)
Time frame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
development of EQ-5D-5L
Time frame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
development of radiological outcome
Time frame: preoperatively and at one follow-up- assessment after a minimum of one year postoperatively
Rate of AE/SAEs
Time frame: preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively
Patient Satisfaction with Treatment Outcome
Time frame: at one follow-up- assessment after a minimum of one year 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 19 Dec 2024.
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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.
Stefan Nikolaus Kroppenstedt, Dr. med. principal investigator
Abteilung für Wirbelsäulenchirurgie Sana Kliniken Sommerfeld
Francis Kilian, Dr. med. principal investigator
Katholisches Klinikum Koblenz
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 19 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 Neck Specific Disability measured by Neck Disability Index (NDI) (time frame: preoperative, 12 months postoperative). 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 19 Dec 2024.