Cortical Bone Trajectory With Patient Guide

Study Overview
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Brief Summary
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The use of patient specific guides with proper preoperative planning, following a cortical bone trajectory technique, should guarantee a successful surgery and benefit of less invasive technique. This study intends to measure the safety and efficacity of MySpine MC patient-specific guide system, when used according to its general indication of use and following the surgical technique suggested by the manufacturer

Detailed Description
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Adult patients affected by degenerative disc disease, meeting all inclusion/exclusion criteria, will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit. They will be provided with an information letter and, in case of acceptance to participate to the study, asked to sign a consent form. After enrolment, each patient will be monitored for 13 months. Data concerning demography, preoperative clinical conditions, surgical details including device implanted and complications occurred, postoperative clinical and/or radiological assessments (as per standard routine at 5 weeks, 3, 7 and 13 months) will be prospectively collected. The level of bone fusion will be evaluated with a postoperative CT scan at 7 ±2 months follow-up

Official Title
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PROSPECTIVE MULTICENTRIC CLINICAL STUDY TO ASSESS SAFETY OF A CORTICAL BONE TRAJECTORY SCREW INSERTION TECHNIQUE WITH THE USE OF PATIENT SPECIFIC DRILL GUIDES

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: MySpine MC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: those affected by degenerative disc disease needing a surgical treatment one/two levels with posterior approach to screw fixation those who need a surgical procedure of lumbar spine stabilization according to Medacta device instruction for use from level L2 to level S1 those who signed consent form to participate to the study Normal healthy patients or with mild systematic disease identified as patients with ASA score 1 or 2 Patients with BMI ≤ 35 kg/m2 non responsive or unsufficient resposive to non -invasive treatment such as analgesics Exclusion Criteria: Patients affected by lytic lystesis and degenerative lystesis with grade≥2 will be excluded Patients <18 years Patient who is pregnant or intends 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

| Intervention/Treatment |
| --- |
|Device: MySpine MC|Spinal stabilization throught the support of patient specific guide, MySpine MC according to cortical bone trajectory technique|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone fusion | Percentage of subjects get bone fusion at index level will be calculated | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perception | A visual analog scale will be filled to assess leg and back pain | preop, 5 weeks, 3months, 6 months, 12 months | 
| Functional status | ODI 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 will be filled | preop, 5 weeks, 3months, 6 months, 12 months | 
| Quality of life | Euroqol 5D questionnaire will be collected to assess quality of life | preop, 5 weeks, 3months, 6 months, 12 months | 
| Safety device | collection of adverse event | preop, 5 weeks, 3months, 6 months, 12 months |