Degenerative Disc Disease, Osteochondrosis, Spondylolysis Lumbar
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMySpine
patient specific guide for screw positioning
Sponsors
Medacta International SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. patients affected by degenerative disc disease, osteochondrosis and grade I spondylolisthesis needing a one/two level surgical treatment with posterior approach and screw fixation 2. those who need a surgical procedure of lumbar spine stabilization from level L1 to level L5. 3. patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery 4. Healthy patients or patients with mild or severe systemic disease identified as patients with ASA score 1, 2 or 3. 5. Patients with BMI ≤ 35 kg/m2 6. non responsive or insufficient response to conservative treatment.
Exclusion criteria
1. Patients presenting contraindications as defined by Medacta instruction for use 2. Patients affected by lytic spondylolisthesis and degenerative spondylolisthesis with grade≥2 will be excluded 3. Patients \<18 years 4. Patients who are pregnant or intend to become pregnant during the study 5. Known substance or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spine surgical patient outcome changing in the time respect the preoperative | baseline, 6 weeks, 3 months, 6 months, 12 months | Change in Core Outcome Measures Index (COMI) for the assessment of people affected by degenerative lumbar disease in daily practice |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spine Disability index | baseline, 6 weeks, 3 months, 6 months, 12 months | 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. |
| Pain perception | baseline, 6 weeks, 3 months, 6 months, 12 months | A visual analog scale (from no pain 0 to severe pain 10) to evaluate low back pain |
| Bone fusion | baseline, 12 months | A postoperative CT scan will be performed to asses bone fusion at index level defining the presence of bridging bone. |
| Incidence of adverse event Device-related | baseline, 6 weeks, 3 months, 6 months, 12 months | Colleciton of all adverse event for all study duration |
Countries
Switzerland
Contacts
Primary ContactElisa Bonacina, PhD
Outcome results
None listed