Intervertebral Disc DiseaseNCT02931279
PASS OCT® Post-market Clinical Follow-up
An observational study of Intervertebral Disc Disease and Spondylolisthesis, run by Medicrea International at 1 site in France.
Trial summary
Prospective, multicenter non comparative and observational study (post-market clinical follow-up). Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017. The inclusion period will be 12 months and the follow-up 24 months Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intervertebral Disc Disease, Spondylolisthesis, Spinal Stenosis
- What is being tested?
- PASS OCT® Spinal System
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Jan 2022
- 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: Patient who need immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital, cervical and/or upper thoracic spine (Occiput-T3).
Who may be able to join
- Patient with
- degenerative disc disease or,
- spondylolisthesis, or
- spinal stenosis, or
- trauma, or
- atlanto-axial fractures with instability or
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- cervical tumors.
- Patient operated with PASS OCT®
- Patient > 18 years
- Patient affiliated to health care insurance (social security in France)
- Patient able to complete a self-administered questionnaire
- Patient able to understand the protocol and the planning visit
- Patient able to sign an informed consent form
Who cannot join
- Patient unable or unwilling to sign an informed consent form
- Patient unable to complete a self-administered questionnaire
- Pregnant patient or intending to get pregnant within the next 3 years
- Patient judged as non-compliant by the investigator or not able to come back for follow-up visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of the Cervical Posterior Fixation System PASS OCT®
Prospective, multicenter non comparative and observational study (post-market clinical follow-up).
Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.
The inclusion period will be 12 months and the follow-up 24 months
Read the detailed description
The primary endpoint is to evaluate the safety of the PASS OCT® system.
The secondary endpoints are to analyze the efficacy of the system with several point of view:
- The quality of fusion and the time of fusion through X rays
- the pain with VAS
- the quality of life thanks to questionnaires: NDI (Neck Disability Index) and JOA for myelopathy
- the daily of the patient: return to work, sport
- the surgeon satisfaction.
- Conditions
- Intervertebral Disc Disease, Spondylolisthesis, Spinal Stenosis, Spinal Neoplasms, Spinal Fractures
- Being tested
- PASS OCT® Spinal System
- Medical subject headings
- Intervertebral disc disease, Spondylolisthesis, Spinal Stenosis, Spinal Neoplasms, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PASS OCT® Spinal SystemDevice
Posterior osteosynthesis of the cervical and upper thoracic spine
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
To quantify and describe adverse events
Measured: 12 months postoperatively
Secondary outcomes (4)
Fusion
Radiological assessment of bony fusion
Measured: 1-6 months, 12 months, 24 months postoperatively
Disability
To assess disability using NDI score
Measured: 1-6 months, 12 months, 24 months postoperatively
Quality of life
To assess quality of life through mJOA scoring system
Measured: 1-6 months, 12 months, 24 months postoperatively
Pain
To assess pain using visual analogue scale
Measured: 1-6 months, 12 months, 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2022
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DiseaseStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medicrea International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephane Fuentes, MD, Principal investigator, Hopital la Timone, Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931279
- Sponsor's protocol ID
- 1701
- Status last verified
- Nov 2023
- First submitted
- 27 Jun 2016
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of the Cervical Posterior Fixation System PASS OCT®
- ClinicalTrials.gov ID
- NCT02931279
- Acronym / sponsor ID
- 1701
- Conditions
- Intervertebral Disc Disease, Spondylolisthesis, Spinal Stenosis, Spinal Neoplasms, Spinal Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medicrea InternationalIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2022 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 13 Oct 2016 (estimated)
- 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, multicenter non comparative and observational study (post-market clinical follow-up).
Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.
The inclusion period will be 12 months and the follow-up 24 months
Detailed description
The primary endpoint is to evaluate the safety of the PASS OCT® system.
The secondary endpoints are to analyze the efficacy of the system with several point of view:
- The quality of fusion and the time of fusion through X rays
- the pain with VAS
- the quality of life thanks to questionnaires: NDI (Neck Disability Index) and JOA for myelopathy
- the daily of the patient: return to work, sport
- the surgeon satisfaction.
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
- Patient who need immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital, cervical and/or upper thoracic spine (Occiput-T3).
Key inclusion criteria (13 listed)
- Patient with
- Patient operated with PASS OCT®
- Patient > 18 years
- Patient affiliated to health care insurance (social security in France)
- Patient able to complete a self-administered questionnaire
Key exclusion criteria (4 listed)
- Patient unable or unwilling to sign an informed consent form
- Patient unable to complete a self-administered questionnaire
- Pregnant patient or intending to get pregnant within the next 3 years
- Patient judged as non-compliant by the investigator or not able to come back for follow-up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PASS OCT® Spinal SystemPosterior osteosynthesis of the cervical and upper thoracic spine | Device | – |
Primary outcome
Adverse events
Time frame: 12 months postoperatively
To quantify and describe adverse events
4 secondary outcomes
Fusion
Time frame: 1-6 months, 12 months, 24 months postoperatively
Disability
Time frame: 1-6 months, 12 months, 24 months postoperatively
Quality of life
Time frame: 1-6 months, 12 months, 24 months postoperatively
Pain
Time frame: 1-6 months, 12 months, 24 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 27 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Stephane Fuentes, MD principal investigator
Hopital la Timone, Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervertebral Disc Disease and Spondylolisthesis, run by Medicrea International at 1 site in France.
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 13 inclusion and 4 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 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Adverse events (time frame: 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 27 Nov 2023.