Cortical Bone Trajectory With Patient Guide

Degenerative Disc Disease Clinical Trial

— MySpine MC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05844358
• Other study ID #: P05.007.05
• Status: Completed
• Start date: June 26, 2019
• Est. completion date: September 7, 2022

Study information

• Verified date: April 2023
• Source: Medacta International SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 7, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

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

Locations

Country	Name	City	State
Belgium	AZ Monica Hospital	Antwerpen,
Belgium	AZ Sint-Elisabeth Turnhout	Turnhout,

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone fusion	Percentage of subjects get bone fusion at index level will be calculated	6 months
Secondary	Pain perception	A visual analog scale will be filled to assess leg and back pain	preop, 5 weeks, 3months, 6 months, 12 months
Secondary	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
Secondary	Quality of life	Euroqol 5D questionnaire will be collected to assess quality of life	preop, 5 weeks, 3months, 6 months, 12 months
Secondary	Safety device	collection of adverse event	preop, 5 weeks, 3months, 6 months, 12 months