MySpine MC: Cortical Bone Trajectory With Patient Guide
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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
Study Design
Outcome Measures
Primary Outcome Measures
- Bone fusion [6 months]
Percentage of subjects get bone fusion at index level will be calculated
Secondary Outcome Measures
- Pain perception [preop, 5 weeks, 3months, 6 months, 12 months]
A visual analog scale will be filled to assess leg and back pain
- Functional status [preop, 5 weeks, 3months, 6 months, 12 months]
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
- Quality of life [preop, 5 weeks, 3months, 6 months, 12 months]
Euroqol 5D questionnaire will be collected to assess quality of life
- Safety device [preop, 5 weeks, 3months, 6 months, 12 months]
collection of adverse event
Eligibility Criteria
Criteria
Inclusion Criteria:
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those affected by degenerative disc disease needing a surgical treatment one/two levels with posterior approach to screw fixation
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those who need a surgical procedure of lumbar spine stabilization according to Medacta device instruction for use from level L2 to level S1
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those who signed consent form to participate to the study
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Normal healthy patients or with mild systematic disease identified as patients with ASA score 1 or 2
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Patients with BMI ≤ 35 kg/m2
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non responsive or unsufficient resposive to non -invasive treatment such as analgesics
Exclusion Criteria:
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Patients affected by lytic lystesis and degenerative lystesis with grade≥2 will be excluded
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Patients <18 years
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Patient who is pregnant or intends to become pregnant during the study
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Known substance or alcohol abuse
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AZ Monica Hospital | Antwerpen, | Belgium | ||
| 2 | AZ Sint-Elisabeth Turnhout | Turnhout, | Belgium |
Sponsors and Collaborators
- Medacta International SA
Investigators
- Principal Investigator: Geert Mahieu, Dr, AZ Monica Hospital
- Principal Investigator: Patricia Verstraete, Dr, AZ Sint-Elisabeth Turnhout
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P05.007.05