An observational study in Degenerative Disc Disease, Spondylolisthesis and Spinal Stenosis, sponsored by Marc Schröder. Completed at 12 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Marc Schröder · Observational
In a multinational prospective study, preoperative, intraoperative, perioperative and follow-up data on patients receiving thoracolumbar pedicle screw placement for degenerative disease or infections or tumors will be collected. The three arms consist of robot-guided (RG), navigated (NV), or freehand (FH) screw insertion.
Introduction A decade ago, minimally invasive surgery (MIS) was considered a promising development in spine surgery, yet the value of the pioneering technologies was questionable. With the growing number of experienced MIS surgeons, the influx of evidence in favour of MIS is rapidly increasing. This makes a compelling argument towards MIS offering distinct clinical benefits over open approaches in terms of blood loss, length of stay, rehabilitation, cost-effectiveness and perioperative patient comfort. Due to the limited or inexistent line-of-sight in MIS procedures, surgeons need to rely on imaging, navigation, and guidance technologies to operate in a safe and efficient manner. Therefore, a plethora of new and ever improving navigational systems have been developed. These systems allow a consistent level of safety and accuracy, on par with results achieved by very experienced free hand surgeons, with a reasonably short learning curve. Computer-based navigation systems were first introduced to spine surgery in 1995 and while they have been long established as standards in certain cranial procedures, they have not been similarly adopted in spine surgery.
Designed to overcome some of the limitations of navigation-based technologies, robot-guided surgery has become commercially available to surgeons worldwide, like SpineAssist® (Mazor Robotics Ltd. Caesarea, Israel) and the recently launched ROSA™ Spine (Zimmer-Biomet, Warsaw, Indiana, USA). These systems are rapidly challenging the gold standards. SpineAssist®, and its upgraded version, the Renaissance®, provides a stable drilling platform and restricts the surgeon's natural full range of motion to 2 degrees of freedom (up/down motion and yaw in the cannula). The system's guidance unit moves into the trajectory based on exact preoperative planning of pedicle screws, while accounting for changes in intervertebral relationships such as due to distraction, cage insertion or changes between the supine patient position in the preoperative CT and the prone patient on the operating table. Published evidence on robot-guided screw placement has demonstrated high levels of accuracy with most reports ranging around 98% of screws placed within the pedicle or with a cortical encroachment of less than 2 mm.4 Although the reliability and accuracy of robot-guided spine surgery have been established, the actual benefits for the patient in terms of clinical outcomes and revision surgeries remain unknown. We have recently conducted cohort studies that showed some evidence that robotic guidance lowers the rate of intraoperative screw revisions and implant related reoperations compared to free hand procedures, while achieving comparable clinical outcomes. We now want to assess these factors, among others, on a higher level of evidence. We aim to conduct a prospective, multicenter, multinational controlled trial comparing clinical and patient reported outcomes of robotic guided (RG) pedicle screw placement vs. navigated (NV) vs. free hand (FH) pedicle screw placement using pooled data from three centers.
Study Design The European Robotic Spinal Instrumentation (EUROSPIN) study is a prospective, international, multicentre, pragmatic, open-label, non-randomized controlled trial comparing the effectiveness of three techniques for pedicle screw instrumentation, namely RG, NV (CT-, O-Arm, or 3DFL-based), and FH. Following the baseline evaluation, patients will receive one of the three treatments, and will subsequently be followed up for 24 months (Figure 1). The primary analysis will be conducted using the 12-month data.
Sample Size Calculation It was determined that, to detect an intergroup difference of 5% in the primary endpoint, 205 patients are required per group to achieve a power of 1 - beta = 0.8 at alpha = 0.05. The incidence rates were based on the published literature, with an approximated incidence rate of the primary endpoint of 0% for the intervention and 5% for the control group. Because the study protocol is in line with the normal clinical follow-up of most centers, a low dropout rate is expected. This led to a minimum total sample size of 615 patients.
Monitoring An epidemiologist from the sponsor institution will organize an initiation monitor visit at every participating center before starting recruitment. This monitor visit will check whether all study staff are properly trained and the delegation of tasks are well documented (complete Investigator Site File, training and delegation logs). An additional audit will be carried out at 6 months after initiation of recruitment to check whether source documentation and eCRF documentation is similar. Throughout the entire study additional queries by the monitor are send to the investigator in the data capturing system to ensure proper data capturing.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's enrollment of 932 is above the median of 119 across 170 observational studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Marc Schröder is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients receiving thoracolumbar transpedicular screw placement for degenerative pathologies (stenosis, spondylolisthesis, degenerative disc disease, recurrent disc herniation), infections, fractures, trauma, or tumors.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm will comprise all patients that receive transpedicular instrumentation by use of a robotic guidance system (SpineAssist or Renaissance, Mazor Robotics, Ltd., Caesarea, Israel or ROSA Spine, Medtech, Montpellier, France).
Procedure: Transpedicular Instrumentation
This arm will comprise all patients that receive transpedicular instrumentation by use of navigation (computer assistance using CT, O-arm or 3D-fluoroscopic imaging).
Procedure: Transpedicular Instrumentation
This arm will comprise all patients that receive transpedicular instrumentation by use of the conventional freehand technique.
Procedure: Transpedicular Instrumentation
Transpedicular screw placement and instrumentation
Revision Surgery for a Malpositioned Pedicle Screw
We defined the primary endpoint as required revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year.
Time frame: 12 months
Intraoperative Screw Revision
Revision or redirection of a placed screw during the same general anesthesia session
Time frame: Intraoperative
Duration of Surgery
Duration of Surgery in minutes
Time frame: Intraoperative
Length of Hospital Stay
Length of Hospital Stay in days (Defined as from admission to discharge, during the hospital stay in which the primary surgery was carried out)
Time frame: Through hospital stay (From admission to discharge of the hospital stay in which the primary surgery was carried out)
Radiation Dose (DAP)
Radiation Dose as DAP (Dose Area Product, cGy cm2)
Time frame: Intraoperative
Estimated Blood Loss
Estimated Blood Loss (ml)
Time frame: Intraoperative
Need for Blood Transfusion
Need for blood transfusion during the hospital stay (Defined as from admission to discharge, during the hospital stay in which the primary surgery was carried out)
Time frame: Through hospital stay (From admission to discharge of the hospital stay in which the primary surgery was carried out)
Intraoperative Complications
Intraoperative Complications
Time frame: 0 weeks
Postoperative Complications
Postoperative Complications
Time frame: 6 weeks
EQ-5D-3L
EQ-5D-3L (Health-related quality of life) EuroQOL-five dimensions 3-level version measures health-related quality of life. The scale is subdivided into an index, ranging from 0 to 1 and normalized to population-specific values, and a "thermometer" or visual analogue scale, ranging from 0 to 100. The two subscores are not combined towards a single score. Higher values represent a better health-related quality of life in both subscores.
Time frame: 2 years
NRS Back Pain Severity
Numeric Rating Scale (NRS) of back pain severity The scale ranges from 0 to 10. Only integers are available to choose from. Higher values represent a higher amount of pain. There are no subscales.
Time frame: 2 years
NRS Leg Pain Severity
Numeric Rating Scale (NRS) of leg pain severity The scale ranges from 0 to 10. Only integers are available to choose from. Higher values represent a higher amount of pain. There are no subscales.
Time frame: 2 years
Oswestry Disability Index
Oswestry Disability Index (ODI) for functional impairment
Time frame: 2 years
Frequency of Use of Analgetics
Frequency of use of analgetics (daily/weekly/not regularly)
Time frame: 2 years
Satisfaction With Symptoms
Satisfaction with symptoms (satisfied/neutral/dissatisfied)
Time frame: 2 years
Smoking Status
Smoking status (active/ceased/never)
Time frame: 2 years
Working Status
Working status (able to work/unable to work)
Time frame: 2 years
Return to Work
Return to work (number of weeks/not yet)
Time frame: 2 years
Overall Rate of Reoperations
Overall rate of reoperations
Time frame: 2 weeks
After attentive consideration the final number of included patients that met the inclusion criteria were 902
| Milestone | Robot Guided | Navigated | Freehand |
|---|---|---|---|
| Started | 389 | 198 | 315 |
| Completed | 380 | 179 | 303 |
| Not completed | 9 | 19 | 12 |
We defined the primary endpoint as required revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year.
| Patients | Robot Guided | Navigated | Freehand |
|---|---|---|---|
| Revision Surgery for a Malpositioned Pedicle Screw | 4 | 7 | 4 |
Revision or redirection of a placed screw during the same general anesthesia session
Results for this outcome have not been posted.
Duration of Surgery in minutes
Results for this outcome have not been posted.
Length of Hospital Stay in days (Defined as from admission to discharge, during the hospital stay in which the primary surgery was carried out)
Results for this outcome have not been posted.
Radiation Dose as DAP (Dose Area Product, cGy cm2)
Results for this outcome have not been posted.
Estimated Blood Loss (ml)
Results for this outcome have not been posted.
Need for blood transfusion during the hospital stay (Defined as from admission to discharge, during the hospital stay in which the primary surgery was carried out)
Results for this outcome have not been posted.
Intraoperative Complications
Results for this outcome have not been posted.
Postoperative Complications
Results for this outcome have not been posted.
EQ-5D-3L (Health-related quality of life) EuroQOL-five dimensions 3-level version measures health-related quality of life. The scale is subdivided into an index, ranging from 0 to 1 and normalized to population-specific values, and a "thermometer" or visual analogue scale, ranging from 0 to 100. The two subscores are not combined towards a single score. Higher values represent a better health-related quality of life in both subscores.
Results for this outcome have not been posted.
Numeric Rating Scale (NRS) of back pain severity The scale ranges from 0 to 10. Only integers are available to choose from. Higher values represent a higher amount of pain. There are no subscales.
Results for this outcome have not been posted.
Numeric Rating Scale (NRS) of leg pain severity The scale ranges from 0 to 10. Only integers are available to choose from. Higher values represent a higher amount of pain. There are no subscales.
Results for this outcome have not been posted.
Oswestry Disability Index (ODI) for functional impairment
Results for this outcome have not been posted.
Frequency of use of analgetics (daily/weekly/not regularly)
Results for this outcome have not been posted.
Satisfaction with symptoms (satisfied/neutral/dissatisfied)
Results for this outcome have not been posted.
Smoking status (active/ceased/never)
Results for this outcome have not been posted.
Working status (able to work/unable to work)
Results for this outcome have not been posted.
Return to work (number of weeks/not yet)
Results for this outcome have not been posted.
Overall rate of reoperations
Results for this outcome have not been posted.
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Robot-Guided Transpedicular Instrumentation | 1/389 (0.3%) | 4/389 (1%) | 41/389 (10.5%) |
| Navigated Transpedicular Instrumentation | 11/198 (5.6%) | 7/198 (3.5%) | 47/198 (23.7%) |
| Freehand Transpedicular Instrumentation | 8/315 (2.5%) | 4/315 (1.3%) | 51/315 (16.2%) |
| Event | Robot-Guided Transpedicular Instrumentation | Navigated Transpedicular Instrumentation | Freehand Transpedicular Instrumentation |
|---|---|---|---|
| Revision Surgery for Malposition/LooseningMusculoskeletal and connective tissue disorders | 4/389 | 7/198 | 4/315 |
| Event | Robot-Guided Transpedicular Instrumentation | Navigated Transpedicular Instrumentation | Freehand Transpedicular Instrumentation |
|---|---|---|---|
| Surgical ComplicationsSurgical and medical procedures | 41/389 | 47/198 | 51/315 |
| Age, Categorical(Participants) | Robot-Guided Transpedicular Instrumentation | Navigated Transpedicular Instrumentation | Freehand Transpedicular Instrumentation | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 217 | 100 | 196 | 513 |
| >=65 years | 172 | 98 | 119 | 389 |
| Age, Continuous(years) | Robot-Guided Transpedicular Instrumentation | Navigated Transpedicular Instrumentation | Freehand Transpedicular Instrumentation | Total |
|---|---|---|---|---|
| Mean | 60.9 ± 12.6 | 63.6 ± 13.6 | 57.8 ± 14.8 | 60.4 ± 13.8 |
| Sex: Female, Male(Participants) | Robot-Guided Transpedicular Instrumentation | Navigated Transpedicular Instrumentation | Freehand Transpedicular Instrumentation | Total |
|---|---|---|---|---|
| Female | — | — | — | 0 |
| Male | — | — | — | 0 |
| Race/Ethnicity, Customized(Participants) | Robot-Guided Transpedicular Instrumentation | Navigated Transpedicular Instrumentation | Freehand Transpedicular Instrumentation | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(participants) | Robot-Guided Transpedicular Instrumentation | Navigated Transpedicular Instrumentation | Freehand Transpedicular Instrumentation | Total |
|---|---|---|---|---|
| Austria | 0 | 1 | 49 | 50 |
| Netherlands | 35 | 1 | 3 | 39 |
| Italy | 296 | 6 | 163 | 465 |
| France | 0 | 0 | 86 | 86 |
| Switzerland | 0 | 122 | 2 | 124 |
| Germany | 11 | 61 | 4 | 76 |
| Spain | 47 | 7 | 8 | 62 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Jan 2019 to primary completion in Jan 2026, 84 months.
Results were first posted in Mar 2026, 2 months after primary completion.
Of 80 observational studies under Intervertebral Disc Degeneration, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 84. This study's 84 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration →