An observational study in Degenerative Disc Disease, Osteochondrosis and Spondylolysis Lumbar, sponsored by Medacta International SA. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Medacta International SA · Observational
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.
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.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's planned enrollment of 44 is below the median of 119 across 170 observational studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Medacta International SA is the lead sponsor of 46 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
spinal stabilization via cortical bone trajectory with the support of patient specific guide (MySpine MC technology)
Device: MySpine
spinal stabilization via standard pedicle screw positioning with the support of patient specific guide (MySpine std technology)
Device: MySpine
patient specific guide for screw positioning
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
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months
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.
Time frame: 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
Time frame: 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.
Time frame: baseline, 12 months
Incidence of adverse event Device-related
Colleciton of all adverse event for all study duration
Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months
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Intervertebral Disc Degeneration →