MySpine MC Versus MySpine Standard

NCT05846477 | Unknown FDA Device

• 1 other identifier: P05.007.06
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Disc Disease; Osteochondrosis; Spondylolysis Lumbar

Outcome Measures

Primary Outcomes (1)

• Spine surgical patient outcome changing in the time respect the preoperative

  Change in Core Outcome Measures Index (COMI) for the assessment of people affected by degenerative lumbar disease in daily practice

  baseline, 6 weeks, 3 months, 6 months, 12 months

Secondary Outcomes (4)

• Spine Disability index

  baseline, 6 weeks, 3 months, 6 months, 12 months

• Pain perception

  baseline, 6 weeks, 3 months, 6 months, 12 months

• Bone fusion

  baseline, 12 months

• Incidence of adverse event Device-related

  baseline, 6 weeks, 3 months, 6 months, 12 months

Study Arms (2)

MySpine MC

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

Device: MySpine

MySpine STD

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

Device: MySpine

Interventions

MySpine DEVICE

patient specific guide for screw positioning

MySpine MC; MySpine STD

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

Patients listed for lumbar intervertebral body fusion meeting all inclusion/exclusion criteria, will be proposed to take part to the current comparative research project during their pre-operative visit (consecutive ongoing recruitment through project leader in daily clinical practice). They will be provided with an information letter and, in case of acceptance to participate to the research project, asked to sign a consent form in order to further use of personal and clinical data collected during standard practice visit. The patient will be assigned to the research project group according to two consecutive series (First serie: MySpine MC and second serie: MySpine STD).

You may qualify if:

• patients affected by degenerative disc disease, osteochondrosis and grade I spondylolisthesis needing a one/two level surgical treatment with posterior approach and screw fixation
• those who need a surgical procedure of lumbar spine stabilization from level L1 to level L5.
• 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
• Healthy patients or patients with mild or severe systemic disease identified as patients with ASA score 1, 2 or 3.
• Patients with BMI ≤ 35 kg/m2
• non responsive or insufficient response to conservative treatment.

You may not qualify if:

• Patients presenting contraindications as defined by Medacta instruction for use
• Patients affected by lytic spondylolisthesis and degenerative spondylolisthesis with grade≥2 will be excluded
• Patients \<18 years
• Patients who are pregnant or intend to become pregnant during the study
• Known substance or alcohol abuse

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (1)

Schulthess Klinik

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Osteochondrosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• François Porchet, Dr

  Schulthess Klinik

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Bonacina, PhD

CONTACT

+41 91 696 60 60; bonacina@medacta.ch

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: February 4, 2021
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

CH (1)