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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MySpine MC | spinal stabilization via cortical bone trajectory with the support of patient specific guide (MySpine MC technology) |
| |
| MySpine STD | spinal stabilization via standard pedicle screw positioning with the support of patient specific guide (MySpine std technology) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MySpine | Device | patient specific guide for screw positioning |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients listed for lumbar intervertebral body fusion meeting all inclusion/exclusion criteria, will be proposed to take part to the current comparative research project during their pre-operative visit (consecutive ongoing recruitment through project leader in daily clinical practice). They will be provided with an information letter and, in case of acceptance to participate to the research project, asked to sign a consent form in order to further use of personal and clinical data collected during standard practice visit. The patient will be assigned to the research project group according to two consecutive series (First serie: MySpine MC and second serie: MySpine STD).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisa Bonacina, PhD | Contact | +41 91 696 60 60 | bonacina@medacta.ch |
| Name | Affiliation | Role |
|---|---|---|
| François Porchet, Dr | Schulthess Klinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schulthess Klinik | Recruiting | Zurich | Switzerland |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D055034 | Osteochondrosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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 |