MySpine MC Versus MySpine Standard

NCT ID: NCT05846477

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-04
• Study Completion Date: 2024-02-28

Brief Summary

This research project compares the clinical performance of the cortical bone trajectory CBT insertion technique with the current clinical Gold standard, the Pedicle screw insertion technique. Both techniques are performed by aid of MySpine patient-specific guide systems.

Detailed Description

Adult subjects, among those whose clinical condition makes them eligible for a spinal stabilization and meeting the inclusion/exclusion criteria, will be invited to participate to the research project and ask to sign a consent in order to further use of personal and clinical data collected during standard practice visit.

The primary objective of the research project is to compare clinical outcomes, in terms of assessing the main outcomes of importance to patients with back problems (pain, function, symptom-specific well-being, quality of life, disability), of spine surgery with cortical bone trajectory screw placement technique respect the traditional pedicle screw placement technique. Preoperative data and collected during visit as per standard routine at 6 weeks, 3, 6 and 12 months postop will be recoreded and assessed for the purpose of this research project.

Conditions

Degenerative Disc Disease; Osteochondrosis; Spondylolysis Lumbar

Study Design

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

Study Groups

MySpine MC

spinal stabilization via cortical bone trajectory with the support of patient specific guide (MySpine MC technology)

MySpine

Intervention Type: DEVICE

patient specific guide for screw positioning

MySpine STD

spinal stabilization via standard pedicle screw positioning with the support of patient specific guide (MySpine std technology)

MySpine

Intervention Type: DEVICE

patient specific guide for screw positioning

Interventions

MySpine

patient specific guide for screw positioning

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. patients affected by degenerative disc disease, osteochondrosis and grade I spondylolisthesis needing a one/two level surgical treatment with posterior approach and screw fixation

2. those who need a surgical procedure of lumbar spine stabilization from level L1 to level L5.

3. patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery

4. Healthy patients or patients with mild or severe systemic disease identified as patients with ASA score 1, 2 or 3.

5. Patients with BMI ≤ 35 kg/m2

6. non responsive or insufficient response to conservative treatment.

Exclusion Criteria

1. Patients presenting contraindications as defined by Medacta instruction for use

2. Patients affected by lytic spondylolisthesis and degenerative spondylolisthesis with grade≥2 will be excluded

3. Patients <18 years

4. Patients who are pregnant or intend to become pregnant during the study

5. 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

François Porchet, Dr

Role: PRINCIPAL_INVESTIGATOR

Schulthess Klinik

Locations

Schulthess Klinik

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Elisa Bonacina, PhD

Role: CONTACT

bonacina@medacta.ch

+41 91 696 60 60

Facility Contacts

François Porchet, Dr

Role: primary

francois.porchet@kws.ch

+41 79 385 72 10

Other Identifiers

P05.007.06

Identifier Type: -

Identifier Source: org_study_id