Cortical Bone Trajectory With Patient Guide (MySpine MC)

PROSPECTIVE MULTICENTRIC CLINICAL STUDY TO ASSESS SAFETY OF A CORTICAL BONE TRAJECTORY SCREW INSERTION TECHNIQUE WITH THE USE OF PATIENT SPECIFIC DRILL GUIDES

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

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: MySpine MC

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

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen,, Belgium
    • AZ Monica Hospital
  • Turnhout,, Belgium
    • AZ Sint-Elisabeth Turnhout

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone fusion	Percentage of subjects get bone fusion at index level will be calculated	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain perception	A visual analog scale will be filled to assess leg and back pain	preop, 5 weeks, 3months, 6 months, 12 months
Functional status	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	preop, 5 weeks, 3months, 6 months, 12 months
Quality of life	Euroqol 5D questionnaire will be collected to assess quality of life	preop, 5 weeks, 3months, 6 months, 12 months
Safety device	collection of adverse event	preop, 5 weeks, 3months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Medacta International SA
• Investigators: Principal Investigator: Geert Mahieu, Dr, AZ Monica Hospital; Principal Investigator: Patricia Verstraete, Dr, AZ Sint-Elisabeth Turnhout

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2019
• Primary Completion (Actual): March 2, 2022
• Study Completion (Actual): September 7, 2022

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Estimate): May 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: P05.007.05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes