MySpine MC Versus MySpine Standard

Recruiting

• Conditions: Degenerative Disc Disease; Osteochondrosis; Spondylolysis Lumbar
• Interventions: Device: MySpine

• Registration Number: NCT05846477
• Lead Sponsor: Medacta International SA

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.

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 Timeline

• Study Start: 2021-02-04
• Study First Submitted: 2023-04-25
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-04
• Last Update Submitted: 2023-05-04
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MySpine MC	MySpine	spinal stabilization via cortical bone trajectory with the support of patient specific guide (MySpine MC technology)
MySpine STD	MySpine	spinal stabilization via standard pedicle screw positioning with the support of patient specific guide (MySpine std technology)

Primary Outcome Measures

Name	Time	Method
Spine surgical patient outcome changing in the time respect the preoperative	baseline, 6 weeks, 3 months, 6 months, 12 months	Change in Core Outcome Measures Index (COMI) for the assessment of people affected by degenerative lumbar disease in daily practice

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Schulthess Klinik; 🇨🇭 Zürich, Switzerland