Clinical trial NCT05844358: Cortical Bone Trajectory With Patient Guide
Official title: PROSPECTIVE MULTICENTRIC CLINICAL STUDY TO ASSESS SAFETY OF A CORTICAL BONE TRAJECTORY SCREW INSERTION TECHNIQUE WITH THE USE OF PATIENT SPECIFIC DRILL GUIDES
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 102
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: 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.

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. those affected by degenerative disc disease needing a surgical treatment one/two levels with posterior approach to screw fixation
2. those who need a surgical procedure of lumbar spine stabilization according to Medacta device instruction for use from level L2 to level S1
3. those who signed consent form to participate to the study
4. Normal healthy patients or with mild systematic disease identified as patients with ASA score 1 or 2
5. Patients with BMI ≤ 35 kg/m2
6. non responsive or unsufficient resposive to non -invasive treatment such as analgesics

Exclusion Criteria:

1. Patients affected by lytic lystesis and degenerative lystesis with grade≥2 will be excluded
2. Patients \<18 years
3. Patient who is pregnant or intends to become pregnant during the study
4. Known substance or alcohol abuse

Primary outcomes:
measure: Bone fusion
timeFrame: 6 months
Secondary outcomes:
measure: Pain perception
timeFrame: preop, 5 weeks, 3months, 6 months, 12 months
measure: Functional status
timeFrame: preop, 5 weeks, 3months, 6 months, 12 months
measure: Quality of life
timeFrame: preop, 5 weeks, 3months, 6 months, 12 months
measure: Safety device
timeFrame: preop, 5 weeks, 3months, 6 months, 12 months
Other outcomes:
Locations:
city: Antwerpen,
country: Belgium
facility: AZ Monica Hospital
city: Turnhout,
country: Belgium
facility: AZ Sint-Elisabeth Turnhout
Study officials:
affiliation: AZ Monica Hospital
name: Geert Mahieu, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ Sint-Elisabeth Turnhout
name: Patricia Verstraete, Dr
role: PRINCIPAL_INVESTIGATOR
References: