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Spine surgery showdown: robot vs. human hand – which is safer?

NCT ID NCT03398915

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at three ways surgeons place screws in the spine during surgery: using a robot, using a navigation system, or doing it by hand. The goal is to see which method leads to fewer screws needing to be fixed in a second surgery within the first year. About 932 adults with spine problems like disc disease, stenosis, or tumors took part across multiple hospitals in Europe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

932 people

The number who actually took part.

Started

Jan 2019

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients receiving thoracolumbar transpedicular screw placement for degenerative pathologies (stenosis, spondylolisthesis, degenerative disc disease, recurrent disc herniation), infections, fractures, trauma, or tumors.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Informed consent * Thoracolumbar pedicle screw placement * Indication for surgery: Degenerative pathologies (stenosis, spondylolisthesis, degenerative disc disease, recurrent disc herniation), infections, tumors, fractures, trauma * Age ≥ 18 Exclusion Criteria * Deformity surgery * \>5 index levels

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Azienda Ospedaliera Papardo

    Messina, 98158, Italy

  • Azienda Ospedaliera Sant'Andrea di Roma

    Roma, 00189, Italy

  • Azienda Ospedaliero Universitaria di Ferrara

    Ferrara, 44124, Italy

  • Bergman Clinics

    Naarden, GE, Netherlands

  • HUG Geneva

    Geneva, Canton of Geneva, Switzerland

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Klinikum Rechts der Isar

    Munich, Germany

  • La Pitié Salpetrière Hospital

    Paris, France

  • M. Bufalini Hospital

    Cesena, 47521, Italy

  • Medical University of Innsbruck

    Innsbruck, Austria

  • Ortho-Klinik Dortmund

    Dortmund, Germany

  • Universitätsmedizin Göttingen

    Göttingen, Germany

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