NCT05553028

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Dec 2022Jan 2028

First Submitted

Initial submission to the registry

September 19, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 26, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2026

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Expected
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

September 19, 2022

Last Update Submit

April 20, 2026

Conditions

OsteosynthesisMazor RobotSpinal SurgeryArthrosis; Spine

Outcome Measures

Primary Outcomes (1)

  • Evaluation of screw placement by a CT scan

    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.

    one day

Study Arms (2)

Robot assisted surgery

EXPERIMENTAL

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

Procedure: Computerised tomography

Conventional surgery

ACTIVE COMPARATOR

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

Procedure: Computerised tomography

Interventions

Computerised tomographyPROCEDURE

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 surgeryRobot assisted surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint Martin

Pessac, 33600, France

Location

Related Publications (1)

  • Aurouer N, Guerin P, Cogniet A, Gangnet N, Pedram M, Piechaud PT; ReSurg; Mangione P. Pedicle screw placement accuracy in robot-assisted versus image-guided freehand surgery of thoraco-lumbar spine (ROBARTHRODESE): study protocol for a single-centre randomized controlled trial. Trials. 2024 Feb 3;25(1):106. doi: 10.1186/s13063-024-07908-1.

    PMID: 38310274DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2022

First Posted

September 23, 2022

Study Start

December 26, 2022

Primary Completion

January 23, 2026

Study Completion (Estimated)

January 1, 2028

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

FR(1)