MySpine MC Versus MySpine Standard

Degenerative Disc Disease Clinical Trial

— MC vs STD  

Official title:

Prospective Comparative Monocentric Research Project Study to Compare Cortical Bone Trajectory Screw Insertion Technique With Pedicle Screw Insertion Technique by Use of Patient Specific Drill Guides

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05846477
• Other study ID #: P05.007.06
• Status: Recruiting
• Start date: February 4, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: May 2023
• Source: Medacta International SA
• Contact: Elisa Bonacina, PhD
• Phone: +41 91 696 60 60
• Email: bonacina[@]medacta.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spondylolysis

Intervention

Device:
• MySpine
patient specific guide for screw positioning

Locations

Country	Name	City	State
Switzerland	Schulthess Klinik	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	baseline, 6 weeks, 3 months, 6 months, 12 months
Secondary	Pain perception	A visual analog scale (from no pain "0" to severe pain "10") to evaluate low back pain	baseline, 6 weeks, 3 months, 6 months, 12 months
Secondary	Bone fusion	A postoperative CT scan will be performed to asses bone fusion at index level defining the presence of bridging bone.	baseline, 12 months
Secondary	Incidence of adverse event Device-related	Colleciton of all adverse event for all study duration	baseline, 6 weeks, 3 months, 6 months, 12 months