UnknownNot Applicable

MySpine MC Versus MySpine Standard

Switzerland44 participantsStarted 2021-02-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Spine surgical patient outcome changing in the time respect the preoperative

Timeframe: baseline, 6 weeks, 3 months, 6 months, 12 months

Trial details

NCT IDNCT05846477

SponsorMedacta International SA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-02-28

Contact for this trial

Elisa Bonacina, PhD

+41 91 696 60 60 bonacina@medacta.ch

View on ClinicalTrials.gov More Degenerative Disc Disease trials