MySpine MC Versus MySpine Standard

Medacta International SA44 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Degenerative Disc Disease Osteochondrosis Spondylolysis Lumbar

Interventions

MySpineDEVICE

patient specific guide for screw positioning

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Schulthess Klinik

Zurich, Switzerland

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months

Secondary Outcomes

Spine Disability index

questionnaire for assessing functional status and quality-of-life impairment in patients with low back pain or spinal cord disease and injury in research and clinical settings. he index enquires about functional limitations in various activities of daily living with the index score ranging from 1 (best) to 100 (worst). Among others, pain intensity, personal hygiene, walking, sleeping, social life, sexual life (optional) and travel are assessed by the patient. Each section has six possible responses, which are scored from 0 to 5.

Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months

Pain perception

A visual analog scale (from no pain "0" to severe pain "10") to evaluate low back pain

Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months

Bone fusion

A postoperative CT scan will be performed to asses bone fusion at index level defining the presence of bridging bone.

Time frame: baseline, 12 months

Incidence of adverse event Device-related

Colleciton of all adverse event for all study duration

Time frame: baseline, 6 weeks, 3 months, 6 months, 12 months

Central Contacts

Elisa Bonacina, PhD

CONTACT

+41 91 696 60 60 bonacina@medacta.ch

Data from ClinicalTrials.gov

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