MySpine MC
DeviceSpinal stabilization throught the support of patient specific guide, MySpine MC according to cortical bone trajectory technique
NCT Number: NCT05844358
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
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Notify Me18 year and older
All sexes
Observational
AZ Monica Hospital, Antwerp, Belgium
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Spinal stabilization throught the support of patient specific guide, MySpine MC according to cortical bone trajectory technique
Time frame: 6 months
Percentage of subjects get bone fusion at index level will be calculated
Time frame: preop, 5 weeks, 3months, 6 months, 12 months
A visual analog scale will be filled to assess leg and back pain
Time frame: 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
Time frame: preop, 5 weeks, 3months, 6 months, 12 months
Euroqol 5D questionnaire will be collected to assess quality of life
Time frame: preop, 5 weeks, 3months, 6 months, 12 months
collection of adverse event
Medacta International SA
Industry
PROSPECTIVE MULTICENTRIC CLINICAL STUDY TO ASSESS SAFETY OF A CORTICAL BONE TRAJECTORY SCREW INSERTION TECHNIQUE WITH THE USE OF PATIENT SPECIFIC DRILL GUIDES
Acronym: MySpine MC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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