MySpine MC Versus MySpine Standard

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Degenerative Disc Disease, Osteochondrosis, Spondylolysis Lumbar

Intervention / Treatment
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* Device: MySpine


Participation Criteria
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Eligibility Criteria
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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 Known substance or alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MySpine MC<br>spinal stabilization via cortical bone trajectory with the support of patient specific guide (MySpine MC technology) | Device: MySpine<br>* patient specific guide for screw positioning<br>|
| MySpine STD<br>spinal stabilization via standard pedicle screw positioning with the support of patient specific guide (MySpine std technology) | Device: MySpine<br>* patient specific guide for screw positioning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline, 6 weeks, 3 months, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | baseline, 12 months | 
| Incidence of adverse event Device-related | Colleciton of all adverse event for all study duration | baseline, 6 weeks, 3 months, 6 months, 12 months |