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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
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MySpine MC | Device | Spinal stabilization throught the support of patient specific guide, MySpine MC according to cortical bone trajectory technique |
| Measure | Description | Time Frame |
|---|---|---|
| Bone fusion | Percentage of subjects get bone fusion at index level will be calculated | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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A consecutive ongoing recruitment through study members in daily clinical practice will take place.
The 102 patients planned for this survey will be recruited by the Investigators meeting all the inclusion/exclusion criteria.
Subjects, among those whose clinical condition makes them eligible for a spinal stabilization, will be invited to participate to the study. Enrolment will take place over a period of 24 months, until the forecasted number of 102 patients has entered into the survey.
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| Name | Affiliation | Role |
|---|---|---|
| Geert Mahieu, Dr | AZ Monica Hospital | Principal Investigator |
| Patricia Verstraete, Dr | AZ Sint-Elisabeth Turnhout | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Monica Hospital | Antwerp | Belgium | ||||
| AZ Sint-Elisabeth Turnhout |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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 |
| Turnhout |
| Belgium |