Clinical trial NCT05846477: MySpine MC Versus MySpine Standard
Official title: Prospective Comparative Monocentric Research Project Study to Compare Cortical Bone Trajectory Screw Insertion Technique With Pedicle Screw Insertion Technique by Use of Patient Specific Drill Guides
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Disc Disease
Osteochondrosis
Spondylolysis Lumbar
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Spine surgical patient outcome changing in the time respect the preoperative
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Spine Disability index
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months
measure: Pain perception
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months
measure: Bone fusion
timeFrame: baseline, 12 months
measure: Incidence of adverse event Device-related
timeFrame: baseline, 6 weeks, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Schulthess Klinik
Study officials:
affiliation: Schulthess Klinik
name: François Porchet, Dr
role: PRINCIPAL_INVESTIGATOR
References: