Degenerative Disc DiseaseMySpine MCNCT05844358
Cortical Bone Trajectory With Patient Guide
An observational study of Degenerative Disc Disease, run by Medacta International SA at 2 sites in Belgium.
Trial summary
The use of patient specific guides with proper preoperative planning, following a cortical bone trajectory technique, should guarantee a successful surgery and benefit of less invasive technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- MySpine MC
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 2 sitesBelgium
- Study dates
- 26 Jun 2019to 7 Sep 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: A consecutive ongoing recruitment through study members in daily clinical practice will take place. The 102 patients planned for this survey will be recruited by the Investigators meeting all the inclusion/exclusion criteria. Subjects, among those whose clinical condition makes them eligible for a spinal stabilization, will be invited to participate to the study. Enrolment will take place over a period of 24 months, until the forecasted number of 102 patients has entered into the survey.
Who may be able to join
- those affected by degenerative disc disease needing a surgical treatment one/two levels with posterior approach to screw fixation
- those who need a surgical procedure of lumbar spine stabilization according to Medacta device instruction for use from level L2 to level S1
- those who signed consent form to participate to the study
- Normal healthy patients or with mild systematic disease identified as patients with ASA score 1 or 2
- Patients with BMI ≤ 35 kg/m2
- non responsive or unsufficient resposive to non -invasive treatment such as analgesics
Who cannot join
- Patients affected by lytic lystesis and degenerative lystesis with grade≥2 will be excluded
- Patients <18 years
- Patient who is pregnant or intends to become pregnant during the study
- Known substance or alcohol abuse
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: PROSPECTIVE MULTICENTRIC CLINICAL STUDY TO ASSESS SAFETY OF A CORTICAL BONE TRAJECTORY SCREW INSERTION TECHNIQUE WITH THE USE OF PATIENT SPECIFIC DRILL GUIDES
The use of patient specific guides with proper preoperative planning, following a cortical bone trajectory technique, should guarantee a successful surgery and benefit of less invasive technique.
This study intends to measure the safety and efficacity of MySpine MC patient-specific guide system, when used according to its general indication of use and following the surgical technique suggested by the manufacturer
Read the detailed description
Adult patients affected by degenerative disc disease, meeting all inclusion/exclusion criteria, will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit. They will be provided with an information letter and, in case of acceptance to participate to the study, asked to sign a consent form.
After enrolment, each patient will be monitored for 13 months. Data concerning demography, preoperative clinical conditions, surgical details including device implanted and complications occurred, postoperative clinical and/or radiological assessments (as per standard routine at 5 weeks, 3, 7 and 13 months) will be prospectively collected. The level of bone fusion will be evaluated with a postoperative CT scan at 7 ±2 months follow-up
- Conditions
- Degenerative Disc Disease
- Being tested
- MySpine MC
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MySpine MCDevice
Spinal stabilization throught the support of patient specific guide, MySpine MC according to cortical bone trajectory technique
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone fusion
Percentage of subjects get bone fusion at index level will be calculated
Measured: 6 months
Secondary outcomes (4)
Pain perception
A visual analog scale will be filled to assess leg and back pain
Measured: preop, 5 weeks, 3months, 6 months, 12 months
Functional status
ODI index questionnaire for assessing functional status and quality-of-life impairment in patients with low back pain or spinal cord disease and injury in research and clinical settings will be filled
Measured: preop, 5 weeks, 3months, 6 months, 12 months
Quality of life
Euroqol 5D questionnaire will be collected to assess quality of life
Measured: preop, 5 weeks, 3months, 6 months, 12 months
Safety device
collection of adverse event
Measured: preop, 5 weeks, 3months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start26 Jun 2019
- Primary completion2 Mar 2022
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geert Mahieu, Dr, Principal investigator, AZ Monica HospitalPatricia Verstraete, Dr, Principal investigator, AZ Sint-Elisabeth Turnhout
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844358
- Sponsor's protocol ID
- P05.007.05
- Acronym
- MySpine MC
- Status last verified
- Apr 2023
- First submitted
- 25 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- 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
- PROSPECTIVE MULTICENTRIC CLINICAL STUDY TO ASSESS SAFETY OF A CORTICAL BONE TRAJECTORY SCREW INSERTION TECHNIQUE WITH THE USE OF PATIENT SPECIFIC DRILL GUIDES
- ClinicalTrials.gov ID
- NCT05844358
- Acronym / sponsor ID
- MySpine MC / P05.007.05
- Conditions
- Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 6 May 2023 (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.
The use of patient specific guides with proper preoperative planning, following a cortical bone trajectory technique, should guarantee a successful surgery and benefit of less invasive technique.
This study intends to measure the safety and efficacity of MySpine MC patient-specific guide system, when used according to its general indication of use and following the surgical technique suggested by the manufacturer
Detailed description
Adult patients affected by degenerative disc disease, meeting all inclusion/exclusion criteria, will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit. They will be provided with an information letter and, in case of acceptance to participate to the study, asked to sign a consent form.
After enrolment, each patient will be monitored for 13 months. Data concerning demography, preoperative clinical conditions, surgical details including device implanted and complications occurred, postoperative clinical and/or radiological assessments (as per standard routine at 5 weeks, 3, 7 and 13 months) will be prospectively collected. The level of bone fusion will be evaluated with a postoperative CT scan at 7 ±2 months follow-up
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
- A consecutive ongoing recruitment through study members in daily clinical practice will take place. The 102 patients planned for this survey will be recruited by the Investigators meeting all the inclusion/exclusion criteria. Subjects, among those whose clinical condition makes them eligible for a spinal stabilization, will be invited to participate to the study. Enrolment will take place over a period of 24 months, until the forecasted number of 102 patients has entered into the survey.
Key inclusion criteria (6 listed)
- those affected by degenerative disc disease needing a surgical treatment one/two levels with posterior approach to screw fixation
- those who need a surgical procedure of lumbar spine stabilization according to Medacta device instruction for use from level L2 to level S1
- those who signed consent form to participate to the study
- Normal healthy patients or with mild systematic disease identified as patients with ASA score 1 or 2
- Patients with BMI ≤ 35 kg/m2
Key exclusion criteria (4 listed)
- Patients affected by lytic lystesis and degenerative lystesis with grade≥2 will be excluded
- Patients <18 years
- Patient who is pregnant or intends to become pregnant during the study
- Known substance or alcohol abuse
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 |
|---|---|---|
| MySpine MCSpinal stabilization throught the support of patient specific guide, MySpine MC according to cortical bone trajectory technique | Device | – |
Primary outcome
Bone fusion
Time frame: 6 months
Percentage of subjects get bone fusion at index level will be calculated
4 secondary outcomes
Pain perception
Time frame: preop, 5 weeks, 3months, 6 months, 12 months
Functional status
Time frame: preop, 5 weeks, 3months, 6 months, 12 months
Quality of life
Time frame: preop, 5 weeks, 3months, 6 months, 12 months
Safety device
Time frame: preop, 5 weeks, 3months, 6 months, 12 months
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 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.
Geert Mahieu, Dr principal investigator
AZ Monica Hospital
Patricia Verstraete, Dr principal investigator
AZ Sint-Elisabeth Turnhout
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 Disc Disease, run by Medacta International SA at 2 sites in Belgium.
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 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 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 2 sites in Belgium. 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?
Bone fusion (time frame: 6 months). 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.