Spinal FracturesNCT02931266
PASS MIS® Post-market Clinical Follow-up
An observational study of Spinal Fractures, run by Medicrea International at 1 site in France.
Trial summary
Prospective, multicenter non comparative and observational study (post-market clinical follow-up). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Fractures
- What is being tested?
- PASS MIS®
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Jan 2018
- 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 suffering from thoraco-lumbar spinal fracture and receiving a posterior osteosynthesis through a mini-invasive approach
Who may be able to join
- Patient which need to be operated to treat a fracture at the lumbar and/or thoracic spine with the PASS MIS® device from MEDICREA®
- Patient > 18years
- Patient with a mature skeleton
- Patient able to understand the protocol and the planning visit
- Patient able to complete a self-administered questionnaire
- Patient who have signed the informed consent form
Who cannot join
- Patient presenting other medical indication than thoracolumbar fracture
- Patient unable or who refuse to sign an informed consent form
- Patient unable to complete a self-administered questionnaire
- Patient judged as non-compliant by the investigator or not able to come back for follow-up visits
- Patient who need to receive or who received an open procedure
- Patient who has been not implanted with the PASS MIS® system
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- Pregnant women or intending to get pregnant within the next 2 years after the surgery
- Patient with contra-indications to do radiographies
- Local infectious state
- Allergy or intolerance to the materials, suspected or known
- Any contra-indications present in the notice of the product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of the PASS MIS® System in the Treatment of Spinal Thoracolumbar Fractures
Prospective, multicenter non comparative and observational study (post-market clinical follow-up).
Read the detailed description
Patients operated with PASS MIS® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.
The inclusion period will be 12 months and the follow-up 24 months
- Conditions
- Spinal Fractures
- Being tested
- PASS MIS®
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PASS MIS®Device
Posterior mini-invasive osteosynthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal stability
To evaluate though X-rays, the efficacy of the device to promote the stability of the instrumented segments.
Measured: 12 months postoperatively
Spinal fusion
Radiological assessment of bony fusion
Measured: 12 months postoperatively
Secondary outcomes (4)
Adverse events
To quantify and describe adverse events
Measured: During surgery, 1-6 months, 12 months, 24 months postoperatively
Disability
To assess patients' disability through ODI questionnaire
Measured: 1-6 months, 12 months, 24 months postoperatively
Patient satisfaction index
To assess patient satisfaction after surgery using a questionnaire
Measured: 1-6 months, 12 months, 24 months postoperatively
Pain
To assess patient's 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 startSep 2016
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: Lack of inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FracturesStudies 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
- 5 participants (actual)
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
- NCT02931266
- Sponsor's protocol ID
- 1102
- Status last verified
- May 2023
- First submitted
- 27 Jun 2016
- Last updated
- 6 May 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 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of the PASS MIS® System in the Treatment of Spinal Thoracolumbar Fractures
- ClinicalTrials.gov ID
- NCT02931266
- Acronym / sponsor ID
- 1102
- Conditions
- Spinal Fractures
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of inclusions
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medicrea InternationalIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (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).
Detailed description
Patients operated with PASS MIS® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.
The inclusion period will be 12 months and the follow-up 24 months
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 suffering from thoraco-lumbar spinal fracture and receiving a posterior osteosynthesis through a mini-invasive approach
Key inclusion criteria (6 listed)
- Patient which need to be operated to treat a fracture at the lumbar and/or thoracic spine with the PASS MIS® device from MEDICREA®
- Patient > 18years
- Patient with a mature skeleton
- Patient able to understand the protocol and the planning visit
- Patient able to complete a self-administered questionnaire
Key exclusion criteria (11 listed)
- Patient presenting other medical indication than thoracolumbar fracture
- Patient unable or who refuse to sign an informed consent form
- Patient unable to complete a self-administered questionnaire
- Patient judged as non-compliant by the investigator or not able to come back for follow-up visits
- Patient who need to receive or who received an open procedure
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 MIS®Posterior mini-invasive osteosynthesis | Device | – |
Primary outcome
Spinal stability
Time frame: 12 months postoperatively
To evaluate though X-rays, the efficacy of the device to promote the stability of the instrumented segments.
Spinal fusion
Time frame: 12 months postoperatively
Radiological assessment of bony fusion
4 secondary outcomes
Adverse events
Time frame: During surgery, 1-6 months, 12 months, 24 months postoperatively
Disability
Time frame: 1-6 months, 12 months, 24 months postoperatively
Patient satisfaction index
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 was stopped early (reason given: Lack of inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 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 Spinal Fractures, 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 6 May 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 was stopped early (reason given: Lack of inclusions). Results are not available in the source record.
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?
Spinal stability (time frame: 12 months postoperatively). The study lists 2 primary outcomes in all. 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 6 May 2023.