MySpine MC Versus MySpine Standard (MC vs STD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Degenerative Disc Disease; Osteochondrosis; Spondylolysis Lumbar
• Intervention / Treatment: Device: MySpine

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 44

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland
    • Recruiting
    • Schulthess Klinik
    • Contact: François Porchet, Dr; Phone Number: +41 79 385 72 10; Email: francois.porchet@kws.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MySpine MC; spinal stabilization via cortical bone trajectory with the support of patient specific guide (MySpine MC technology)	Device: MySpine; patient specific guide for screw positioning
MySpine STD; spinal stabilization via standard pedicle screw positioning with the support of patient specific guide (MySpine std technology)	Device: MySpine; patient specific guide for screw positioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Incidence of adverse event Device-related	Colleciton of all adverse event for all study duration	baseline, 6 weeks, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Medacta International SA
• Investigators: Principal Investigator: François Porchet, Dr, Schulthess Klinik

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2021
• Primary Completion (Anticipated): February 28, 2024
• Study Completion (Anticipated): February 28, 2024

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Estimate): May 5, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylosis; Intervertebral Disc Degeneration; Spondylolysis; Osteochondrosis
• Other Study ID Numbers: P05.007.06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No