Degenerative Disc DiseaseMC vs STDNCT05846477
MySpine MC Versus MySpine Standard
An observational study of Degenerative Disc Disease and Osteochondrosis, run by Medacta International SA at 1 site in Switzerland.
Trial summary
This research project compares the clinical performance of the cortical bone trajectory CBT insertion technique with the current clinical Gold standard, the Pedicle screw insertion technique. Both techniques are performed by aid of MySpine patient-specific guide systems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Osteochondrosis, Spondylolysis Lumbar
- What is being tested?
- MySpine
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Feb 2021to 28 Feb 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: Patients listed for lumbar intervertebral body fusion meeting all inclusion/exclusion criteria, will be proposed to take part to the current comparative research project during their pre-operative visit (consecutive ongoing recruitment through project leader in daily clinical practice). They will be provided with an information letter and, in case of acceptance to participate to the research project, asked to sign a consent form in order to further use of personal and clinical data collected during standard practice visit. The patient will be assigned to the research project group according to two consecutive series (First serie: MySpine MC and second serie: MySpine STD).
Who may be able to join
- patients affected by degenerative disc disease, osteochondrosis and grade I spondylolisthesis needing a one/two level surgical treatment with posterior approach and screw fixation
- those who need a surgical procedure of lumbar spine stabilization from level L1 to level L5.
- patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery
- Healthy patients or patients with mild or severe systemic disease identified as patients with ASA score 1, 2 or 3.
- Patients with BMI ≤ 35 kg/m2
- non responsive or insufficient response to conservative treatment.
Who cannot join
- Patients presenting contraindications as defined by Medacta instruction for use
- Patients affected by lytic spondylolisthesis and degenerative spondylolisthesis with grade≥2 will be excluded
- Patients <18 years
- Patients who are pregnant or intend to become pregnant during the study
- Known substance or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Schulthess Klinik
Zurich
François Porchet, Dr, +41 79 385 72 10, francois.porchet@kws.ch
About this study
Official title: Prospective Comparative Monocentric Research Project Study to Compare Cortical Bone Trajectory Screw Insertion Technique With Pedicle Screw Insertion Technique by Use of Patient Specific Drill Guides
This research project compares the clinical performance of the cortical bone trajectory CBT insertion technique with the current clinical Gold standard, the Pedicle screw insertion technique. Both techniques are performed by aid of MySpine patient-specific guide systems.
Read the detailed description
Adult subjects, among those whose clinical condition makes them eligible for a spinal stabilization and meeting the inclusion/exclusion criteria, will be invited to participate to the research project and ask to sign a consent in order to further use of personal and clinical data collected during standard practice visit.
The primary objective of the research project is to compare clinical outcomes, in terms of assessing the main outcomes of importance to patients with back problems (pain, function, symptom-specific well-being, quality of life, disability), of spine surgery with cortical bone trajectory screw placement technique respect the traditional pedicle screw placement technique. Preoperative data and collected during visit as per standard routine at 6 weeks, 3, 6 and 12 months postop will be recoreded and assessed for the purpose of this research project.
- Being tested
- MySpine
- Medical subject headings
- Intervertebral Disc Degeneration, Osteochondrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MySpineDevice
patient specific guide for screw positioning
| Study group | Role | What they receive |
|---|---|---|
| MySpine MC | spinal stabilization via cortical bone trajectory with the support of patient specific guide (MySpine MC technology) Receives: Device: MySpine | |
| MySpine STD | spinal stabilization via standard pedicle screw positioning with the support of patient specific guide (MySpine std technology) Receives: Device: MySpine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spine surgical patient outcome changing in the time respect the preoperative
Change in Core Outcome Measures Index (COMI) for the assessment of people affected by degenerative lumbar disease in daily practice
Measured: baseline, 6 weeks, 3 months, 6 months, 12 months
Secondary outcomes (4)
Spine Disability 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.
he index enquires about functional limitations in various activities of daily living with the index score ranging from 1 (best) to 100 (worst). Among others, pain intensity, personal hygiene, walking, sleeping, social life, sexual life (optional) and travel are assessed by the patient. Each section has six possible responses, which are scored from 0 to 5.
Measured: baseline, 6 weeks, 3 months, 6 months, 12 months
Pain perception
A visual analog scale (from no pain "0" to severe pain "10") to evaluate low back pain
Measured: baseline, 6 weeks, 3 months, 6 months, 12 months
Bone fusion
A postoperative CT scan will be performed to asses bone fusion at index level defining the presence of bridging bone.
Measured: baseline, 12 months
Incidence of adverse event Device-related
Colleciton of all adverse event for all study duration
Measured: baseline, 6 weeks, 3 months, 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 start4 Feb 2021
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- François Porchet, Dr, Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846477
- Sponsor's protocol ID
- P05.007.06
- Acronym
- MC vs STD
- Status last verified
- May 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
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 Comparative Monocentric Research Project Study to Compare Cortical Bone Trajectory Screw Insertion Technique With Pedicle Screw Insertion Technique by Use of Patient Specific Drill Guides
- ClinicalTrials.gov ID
- NCT05846477
- Acronym / sponsor ID
- MC vs STD / P05.007.06
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- 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.
This research project compares the clinical performance of the cortical bone trajectory CBT insertion technique with the current clinical Gold standard, the Pedicle screw insertion technique. Both techniques are performed by aid of MySpine patient-specific guide systems.
Detailed description
Adult subjects, among those whose clinical condition makes them eligible for a spinal stabilization and meeting the inclusion/exclusion criteria, will be invited to participate to the research project and ask to sign a consent in order to further use of personal and clinical data collected during standard practice visit.
The primary objective of the research project is to compare clinical outcomes, in terms of assessing the main outcomes of importance to patients with back problems (pain, function, symptom-specific well-being, quality of life, disability), of spine surgery with cortical bone trajectory screw placement technique respect the traditional pedicle screw placement technique. Preoperative data and collected during visit as per standard routine at 6 weeks, 3, 6 and 12 months postop will be recoreded and assessed for the purpose of this research project.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MySpine MC | – | Device: MySpinespinal stabilization via cortical bone trajectory with the support of patient specific guide (MySpine MC technology) |
| MySpine STD | – | Device: MySpinespinal stabilization via standard pedicle screw positioning with the support of patient specific guide (MySpine std technology) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients listed for lumbar intervertebral body fusion meeting all inclusion/exclusion criteria, will be proposed to take part to the current comparative research project during their pre-operative visit (consecutive ongoing recruitment through project leader in daily clinical practice). They will be provided with an information letter and, in case of acceptance to participate to the research project, asked to sign a consent form in order to further use of personal and clinical data collected during standard practice visit. The patient will be assigned to the research project group according to two consecutive series (First serie: MySpine MC and second serie: MySpine STD).
Key inclusion criteria (6 listed)
- patients affected by degenerative disc disease, osteochondrosis and grade I spondylolisthesis needing a one/two level surgical treatment with posterior approach and screw fixation
- those who need a surgical procedure of lumbar spine stabilization from level L1 to level L5.
- patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery
- Healthy patients or patients with mild or severe systemic disease identified as patients with ASA score 1, 2 or 3.
- Patients with BMI ≤ 35 kg/m2
Key exclusion criteria (5 listed)
- Patients presenting contraindications as defined by Medacta instruction for use
- Patients affected by lytic spondylolisthesis and degenerative spondylolisthesis with grade≥2 will be excluded
- Patients <18 years
- Patients who are pregnant or intend 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 |
|---|---|---|
| MySpinepatient specific guide for screw positioning | Device | MySpine MC, MySpine STD |
Primary outcome
Spine surgical patient outcome changing in the time respect the preoperative
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months
Change in Core Outcome Measures Index (COMI) for the assessment of people affected by degenerative lumbar disease in daily practice
4 secondary outcomes
Spine Disability index
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months
Pain perception
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months
Bone fusion
Time frame: baseline, 12 months
Incidence of adverse event Device-related
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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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.
François Porchet, Dr principal investigator
Schulthess Klinik
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 Degenerative Disc Disease and Osteochondrosis, run by Medacta International SA at 1 site in Switzerland.
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 5 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: status not confirmed, 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisa Bonacina, PhD (+41 91 696 60 60, bonacina@medacta.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spine surgical patient outcome changing in the time respect the preoperative (time frame: baseline, 6 weeks, 3 months, 6 months, 12 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.