UnknownNot Applicable

MySpine MC Versus MySpine Standard

Switzerland44 participantsStarted 2021-02-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Spine surgical patient outcome changing in the time respect the preoperative

Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months

Trial details

NCT IDNCT05846477

SponsorMedacta International SA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-02-28

Contact for this trial

Elisa Bonacina, PhD

+41 91 696 60 60 bonacina@medacta.ch

View on ClinicalTrials.gov More Degenerative Disc Disease trials