Cortical Bone Trajectory With Patient Guide

NCT05844358 | Completed FDA Device

• 1 other identifier: P05.007.05
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 2

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

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• Bone fusion

  Percentage of subjects get bone fusion at index level will be calculated

  6 months

Secondary Outcomes (4)

• Pain perception

  preop, 5 weeks, 3months, 6 months, 12 months

• Functional status

  preop, 5 weeks, 3months, 6 months, 12 months

• Quality of life

  preop, 5 weeks, 3months, 6 months, 12 months

• Safety device

  preop, 5 weeks, 3months, 6 months, 12 months

Interventions

MySpine MC DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (2)

AZ Monica Hospital

Antwerp, Belgium

Location

AZ Sint-Elisabeth Turnhout

Turnhout, Belgium

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Geert Mahieu, Dr

  AZ Monica Hospital

  PRINCIPAL INVESTIGATOR

• Patricia Verstraete, Dr

  AZ Sint-Elisabeth Turnhout

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: June 26, 2019
• Primary Completion: March 2, 2022
• Study Completion: September 7, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)