Cortical Bone Trajectory With Patient Guide

NCT ID: NCT05844358

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-26
• Study Completion Date: 2022-09-07

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

Conditions

Degenerative Disc Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

MySpine MC

Spinal stabilization throught the support of patient specific guide, MySpine MC according to cortical bone trajectory technique

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medacta International SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geert Mahieu, Dr

Role: PRINCIPAL_INVESTIGATOR

AZ Monica Hospital

Patricia Verstraete, Dr

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Elisabeth Turnhout

Locations

AZ Monica Hospital

Antwerp, , Belgium

AZ Sint-Elisabeth Turnhout

Turnhout, , Belgium

Countries

Belgium

Other Identifiers

P05.007.05

Identifier Type: -

Identifier Source: org_study_id