MySpine MC Versus MySpine Standard (MC vs STD)

Medacta

Status: Enrolling

Conditions: Degenerative Disc Disease; Osteochondrosis; Spondylolysis Lumbar

Treatments: Device: MySpine

Study type: Observational

Funder types: Industry

Identifiers

NCT05846477

P05.007.06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

44 participants in 2 patient groups

MySpine MC

Description:

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

Treatment:

Device: MySpine

MySpine STD

Description:

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

Treatment:

Device: MySpine