Degenerative Disc DiseaseMUST MINI PMSNCT05821920
A Safety Study on Posterior Pedicle Screw System
An observational study of Degenerative Disc Disease and Trauma Injury, run by Medacta International SA at 1 site in Germany.
Trial summary
The goal of this study is to assess the MUST MINI system safety in patient who will undergo a posterior cervical spine fusion intervention. Patients will be invited to partecipate during preoperative visit and follow the postoperative visits according to the standard practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Trauma Injury, Tumor
- What is being tested?
- MUST MINI system
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jun 2021to 28 Jun 2025
- 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: All patients who will undergo a posterior cervical spine fusion with MUST MINI system and respecting the inclusion criteria will be invited to participate to the study during the preoperative visit
Who may be able to join
- those affected by degenerative disc disease needing a posterior surgical instrumented treatment aimed at segmental fusion,
- those who will undergo posterior fixation due to traumatic lesion or tumor,
- Patients with BMI ≤ 35 kg/m2,
- those who signed the consent form to participate to the study.
Who cannot join
- Patients <18 years,
- Patients who are pregnant or intend to become pregnant during the study.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
München Klinik Bogenhausen
München
Jens Lehmberg, Prof Dr, 089/9270-2021, neurochirugie@muenchen-klinik.de
About this study
Official title: Prospective Multicentric Clinical Study to Assess Safety of MUST MINI Posterior Cervical System.
The goal of this study is to assess the MUST MINI system safety in patient who will undergo a posterior cervical spine fusion intervention. Patients will be invited to partecipate during preoperative visit and follow the postoperative visits according to the standard practice.
Read the detailed description
Patient who will undergo a posterior cervical spine fusion intervention, will be invited during preoperative visit to take part to the study.
The study is an observational multicentric study with an enrolment period of 12 months with the aim to assess the safety of MUST MINI system.
All adverse events will be collected for all study duration, classified as device and not device related. Screw failure rate is calculated considering screw loosening, breakage, lost-reduction events.
Standard radiological investigations are previewed at preoperative visit, before discharge and at 6 weeks and 12 months follow-up after surgery visits; the risk of any further exposure to radiation other than it's routine use in a diagnostic manner within the follow-up period can be excluded.
A final visit at 12 months level index fusion will be evaluated clinically as well as radiographically, with a confirmation CT scan as per standard of care. Screw placement accuracy will be evaluated during this visit.
A functional cervical x-ray is considered also during last follow-up (12 months after surgery) in order to assess cervical spine functionality.
- Conditions
- Degenerative Disc Disease, Trauma Injury, Tumor
- Being tested
- MUST MINI system
- Medical subject headings
- Intervertebral Disc Degeneration, Accidental Injuries, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUST MINI systemDevice
cervical posterior fixation system
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of MUST MINI system safety
collection of adverse event
Measured: 24 months
Secondary outcomes (6)
Clinical outcomes
mJOA questionnaire, a 18-point investigator-administered scale separately addresses motor dysfunction of the upper extremity (MDUE) and motor dysfunction of the lower extremity (MDLE), sensory loss of the upper extremity, and sphincter dysfunction (SD). Severe myelopathy (0-11), moderate myelopathy (12-14), mild myelopahty (15-17).
Measured: preop, 6 weeks, 6 months, 12 months
Clinical outcomes
NDI questionnaire. Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.
0-4points (0-8%) no disability, 5-14points ( 10 - 28%) mild disability, 15-24points (30-48% ) moderate disability, 25-34points (50- 64%) severe disability, 35-50points (70-100%) complete disability
Measured: preop, 6 weeks, 6 months, 12 months
Clinical outcomes
EQ-5D questionnaire consists of two section, descriptive and a visual analog scale to describe the own health status. The score is calculated by assigning a numerical value to each response level (i.e., 1 for "no problems", 5 for "extreme problems"/"unable to") and summing these values across the five items, resulting in a score from 5 to 25.
Measured: preop, 6 weeks, 6 months, 12 months
Clinical outcomes
VAS pain scale measure the pain intensity with a scale from 0 ('no pain') to 10 ('pain as bad as it could possibly be').
Measured: preop, 6 weeks, 6 months, 12 months
Bone fusion at index level
For each level a CT examination will be performed in order to define if bone fusion is or not. The presence or absence of bridging trabecular bone across the segment can identify is reported.
Measured: 12 month
Cervical spine functionality
Sandard functional x-ray is performed in order to measure the segmental range of motion in the lumbar spine during flexion-extension with the purpose of gathering additional data for the diagnosis of instability.
Measured: Immediate postop, 6 weeks, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start28 Jun 2021
- Primary completion28 Jun 2023
- Study completion28 Jun 2025 (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
- Jens Lehmberg, Prof Med, Principal investigator, München Klinik Bogenhausen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821920
- Sponsor's protocol ID
- P05.008.01
- Acronym
- MUST MINI PMS
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2023
- Last updated
- 1 May 2024
- 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 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentric Clinical Study to Assess Safety of MUST MINI Posterior Cervical System.
- ClinicalTrials.gov ID
- NCT05821920
- Acronym / sponsor ID
- MUST MINI PMS / P05.008.01
- Conditions
- Degenerative Disc Disease, Trauma Injury, Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2025 (estimated)
- First posted
- 20 Apr 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 goal of this study is to assess the MUST MINI system safety in patient who will undergo a posterior cervical spine fusion intervention. Patients will be invited to partecipate during preoperative visit and follow the postoperative visits according to the standard practice.
Detailed description
Patient who will undergo a posterior cervical spine fusion intervention, will be invited during preoperative visit to take part to the study.
The study is an observational multicentric study with an enrolment period of 12 months with the aim to assess the safety of MUST MINI system.
All adverse events will be collected for all study duration, classified as device and not device related. Screw failure rate is calculated considering screw loosening, breakage, lost-reduction events.
Standard radiological investigations are previewed at preoperative visit, before discharge and at 6 weeks and 12 months follow-up after surgery visits; the risk of any further exposure to radiation other than it's routine use in a diagnostic manner within the follow-up period can be excluded.
A final visit at 12 months level index fusion will be evaluated clinically as well as radiographically, with a confirmation CT scan as per standard of care. Screw placement accuracy will be evaluated during this visit.
A functional cervical x-ray is considered also during last follow-up (12 months after surgery) in order to assess cervical spine functionality.
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
- All patients who will undergo a posterior cervical spine fusion with MUST MINI system and respecting the inclusion criteria will be invited to participate to the study during the preoperative visit
Key inclusion criteria (4 listed)
- those affected by degenerative disc disease needing a posterior surgical instrumented treatment aimed at segmental fusion,
- those who will undergo posterior fixation due to traumatic lesion or tumor,
- Patients with BMI ≤ 35 kg/m2,
- those who signed the consent form to participate to the study.
Key exclusion criteria (2 listed)
- Patients <18 years,
- Patients who are pregnant or intend to become pregnant during the study.
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 |
|---|---|---|
| MUST MINI systemcervical posterior fixation system | Device | – |
Primary outcome
Assessment of MUST MINI system safety
Time frame: 24 months
collection of adverse event
6 secondary outcomes
Clinical outcomes
Time frame: preop, 6 weeks, 6 months, 12 months
Clinical outcomes
Time frame: preop, 6 weeks, 6 months, 12 months
Clinical outcomes
Time frame: preop, 6 weeks, 6 months, 12 months
Clinical outcomes
Time frame: preop, 6 weeks, 6 months, 12 months
Bone fusion at index level
Time frame: 12 month
Cervical spine functionality
Time frame: Immediate postop, 6 weeks, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- 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.
Jens Lehmberg, Prof Med principal investigator
München Klinik Bogenhausen
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 Trauma Injury, run by Medacta International SA at 1 site 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 2 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 1 May 2024. 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 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?
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?
Assessment of MUST MINI system safety (time frame: 24 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 1 May 2024.