Study Comparing Arthrodesis Technique of Thoracic and/or Lumbar Spine by Posterior Approach Performed by Robot-assisted Surgery (Robot Mazor X Stealth ™) Versus Conventional Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-26

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Osteosynthesis by pedicle screwing is the reference technique since the 1980s, due to the quality of the mechanical grip of the screw in the pedicle, despite difficulties of placing the implant in this narrow tunnel.

This precision was improved by fluoroscopy, then by navigation, which made it possible to reduce the extra-pedicular placement of the screws and consequently the complications.

Since the 2000s, robotic has been developed in all areas, including medicine and surgery, (Da Vinci robot in urology) and several robots are currently marketed for spinal surgery, Medtronic's Mazor X Stealth ™ robot being the most successful.

The aim of this study is to evaluate on a prospective randomized comparative study the quality of the placement of the screws as well as the occurrence of complications, the clinical results and the medico-economic interest that robotic surgery can bring.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mazor X Stealth Versus O-arm Navigation for Pedicle Screw Insertion

NCT04353895

Disorder of Spine

UNKNOWN NA

Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation

NCT06153511

SPINAL Fracture Vertebral Fractures Spinal Stenosis +3 more

COMPLETED NA

Clinical Trial of Minimally Invasive Robotic Spine Surgery

NCT02121249

Degenerative Lumbar Spinal Stenosis

COMPLETED NA

Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System

NCT05884593

Spinal Deformity Spinal Infection Trauma +2 more

ACTIVE_NOT_RECRUITING NA

Clinical Evidence of Robot Guided vs. Navigated vs. Free Hand Lumbar Spinal Fusion

NCT02998060

Spondylolisthesis Intervertebral Disc Degeneration

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteosynthesis Mazor Robot Spinal Surgery Arthrosis; Spine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Robot assisted surgery

Patient operated for thoracic and/or lumbar spine arthrodesis with robot assistance Mazor

Group Type EXPERIMENTAL

Computerised tomography

Intervention Type PROCEDURE

Screws placement will be evaluated for each patient by a CT scan on D1 post-intervention. The evaluation of the placement of the screws (reading of the CT images) will be carried out by 2 radiologists independent of the surgical team, blinded to the technique used for the placement of the screws (robot-assisted/conventional surgery). In case of disagreement between the 2 evaluators, a 3rd evaluator will be requested.

Conventional surgery

Patient operated for thoracic and/or lumbar spine arthrodesis with conventional surgery

Group Type ACTIVE_COMPARATOR

Computerised tomography

Intervention Type PROCEDURE

Screws placement will be evaluated for each patient by a CT scan on D1 post-intervention. The evaluation of the placement of the screws (reading of the CT images) will be carried out by 2 radiologists independent of the surgical team, blinded to the technique used for the placement of the screws (robot-assisted/conventional surgery). In case of disagreement between the 2 evaluators, a 3rd evaluator will be requested.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Computerised tomography

Screws placement will be evaluated for each patient by a CT scan on D1 post-intervention. The evaluation of the placement of the screws (reading of the CT images) will be carried out by 2 radiologists independent of the surgical team, blinded to the technique used for the placement of the screws (robot-assisted/conventional surgery). In case of disagreement between the 2 evaluators, a 3rd evaluator will be requested.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male, female, over 18 years old,
* Any patient operated for thoracic and/or lumbar spine arthrodesis (spondylolisthesis, asymmetric disc disease, spinal instability, spinal deformities, advanced disc disease),
* Patient having given his free, informed and written consent to participate in the study,
* Patient able to answer questionnaires, able to communicate in the language of the country of the study,
* Negative pregnancy test,
* Patient affiliated to a social security scheme or beneficiary of such a scheme.

Exclusion Criteria

* Minor,
* Psychological disorders,
* Addiction to analgesics,
* Chronic infection,
* History of instrumented lumbar surgery,
* BMI greater than or equal to 40kg/m²,
* Pregnant or breastfeeding woman,
* Patient participating in another clinical study,
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No