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OpenTrials
Completed

NCT Number: NCT05844358

Cortical Bone Trajectory With Patient Guide

The use of patient specific guides with proper preoperative planning, following a cortical bone trajectory technique, should guarantee a successful surgery and benefit of less invasive technique.

This study intends to measure the safety and efficacity of MySpine MC patient-specific guide system, when used according to its general indication of use and following the surgical technique suggested by the manufacturer

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Monica Hospital, Antwerp, Belgium

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About this study

Adult patients affected by degenerative disc disease, meeting all inclusion/exclusion criteria, will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit. They will be provided with an information letter and, in case of acceptance to participate to the study, asked to sign a consent form.

After enrolment, each patient will be monitored for 13 months. Data concerning demography, preoperative clinical conditions, surgical details including device implanted and complications occurred, postoperative clinical and/or radiological assessments (as per standard routine at 5 weeks, 3, 7 and 13 months) will be prospectively collected. The level of bone fusion will be evaluated with a postoperative CT scan at 7 ±2 months follow-up

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • those affected by degenerative disc disease needing a surgical treatment one/two levels with posterior approach to screw fixation
  • those who need a surgical procedure of lumbar spine stabilization according to Medacta device instruction for use from level L2 to level S1
  • those who signed consent form to participate to the study
  • Normal healthy patients or with mild systematic disease identified as patients with ASA score 1 or 2
  • Patients with BMI ≤ 35 kg/m2
  • non responsive or unsufficient resposive to non -invasive treatment such as analgesics

Exclusion criteria

  • Patients affected by lytic lystesis and degenerative lystesis with grade≥2 will be excluded
  • Patients <18 years
  • Patient who is pregnant or intends to become pregnant during the study
  • Known substance or alcohol abuse

Treatment and study plan

MySpine MC

Device

Spinal stabilization throught the support of patient specific guide, MySpine MC according to cortical bone trajectory technique

Primary outcomes

  1. Bone fusion

    Time frame: 6 months

    Percentage of subjects get bone fusion at index level will be calculated

Secondary outcomes

  1. Pain perception

    Time frame: preop, 5 weeks, 3months, 6 months, 12 months

    A visual analog scale will be filled to assess leg and back pain

  2. Functional status

    Time frame: preop, 5 weeks, 3months, 6 months, 12 months

    ODI 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 will be filled

  3. Quality of life

    Time frame: preop, 5 weeks, 3months, 6 months, 12 months

    Euroqol 5D questionnaire will be collected to assess quality of life

  4. Safety device

    Time frame: preop, 5 weeks, 3months, 6 months, 12 months

    collection of adverse event

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

PROSPECTIVE MULTICENTRIC CLINICAL STUDY TO ASSESS SAFETY OF A CORTICAL BONE TRAJECTORY SCREW INSERTION TECHNIQUE WITH THE USE OF PATIENT SPECIFIC DRILL GUIDES

Acronym: MySpine MC

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 6, 2023
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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