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Trial Outcomes & Findings for The European Robotic Spinal Instrumentation (EUROSPIN) Study (NCT NCT03398915)

NCT ID: NCT03398915

Last Updated: 2026-03-31

Results Overview

We defined the primary endpoint as required revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year.

Recruitment status

ACTIVE_NOT_RECRUITING

Target enrollment

932 participants

Primary outcome timeframe

12 months

Results posted on

2026-03-31

Participant Flow

After attentive consideration the final number of included patients that met the inclusion criteria were 902

Participant milestones

Participant milestones
Measure
Robot Guided
Robotically Guided Screw Placement
Navigated
Navigation Assisted Screw Placement
Freehand
Freehand Technique
Overall Study
STARTED
389
198
315
Overall Study
COMPLETED
380
179
303
Overall Study
NOT COMPLETED
9
19
12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sex was not collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Robot-Guided Transpedicular Instrumentation
n=389 Participants
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). Transpedicular Instrumentation: Transpedicular screw placement and instrumentation
Navigated Transpedicular Instrumentation
n=198 Participants
This arm will comprise all patients that receive transpedicular instrumentation by use of navigation (computer assistance using CT, O-arm or 3D-fluoroscopic imaging). Transpedicular Instrumentation: Transpedicular screw placement and instrumentation
Freehand Transpedicular Instrumentation
n=315 Participants
This arm will comprise all patients that receive transpedicular instrumentation by use of the conventional freehand technique. Transpedicular Instrumentation: Transpedicular screw placement and instrumentation
Total
n=902 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=389 Participants
0 Participants
n=198 Participants
0 Participants
n=315 Participants
0 Participants
n=902 Participants
Age, Categorical
Between 18 and 65 years
217 Participants
n=389 Participants
100 Participants
n=198 Participants
196 Participants
n=315 Participants
513 Participants
n=902 Participants
Age, Categorical
>=65 years
172 Participants
n=389 Participants
98 Participants
n=198 Participants
119 Participants
n=315 Participants
389 Participants
n=902 Participants
Age, Continuous
60.9 years
STANDARD_DEVIATION 12.6 • n=389 Participants
63.6 years
STANDARD_DEVIATION 13.6 • n=198 Participants
57.8 years
STANDARD_DEVIATION 14.8 • n=315 Participants
60.4 years
STANDARD_DEVIATION 13.8 • n=902 Participants
Sex: Female, Male
Female
—
—
—
0 Participants
Sex was not collected
Sex: Female, Male
Male
—
—
—
0 Participants
Sex was not collected
Race/Ethnicity, Customized
—
—
—
0 Participants
Race/Ethnicity was not considered in the study
Region of Enrollment
Austria
0 participants
n=389 Participants
1 participants
n=198 Participants
49 participants
n=315 Participants
50 participants
n=902 Participants
Region of Enrollment
Netherlands
35 participants
n=389 Participants
1 participants
n=198 Participants
3 participants
n=315 Participants
39 participants
n=902 Participants
Region of Enrollment
Italy
296 participants
n=389 Participants
6 participants
n=198 Participants
163 participants
n=315 Participants
465 participants
n=902 Participants
Region of Enrollment
France
0 participants
n=389 Participants
0 participants
n=198 Participants
86 participants
n=315 Participants
86 participants
n=902 Participants
Region of Enrollment
Switzerland
0 participants
n=389 Participants
122 participants
n=198 Participants
2 participants
n=315 Participants
124 participants
n=902 Participants
Region of Enrollment
Germany
11 participants
n=389 Participants
61 participants
n=198 Participants
4 participants
n=315 Participants
76 participants
n=902 Participants
Region of Enrollment
Spain
47 participants
n=389 Participants
7 participants
n=198 Participants
8 participants
n=315 Participants
62 participants
n=902 Participants

PRIMARY outcome

Timeframe: 12 months

We defined the primary endpoint as required revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year.

Outcome measures

Outcome measures
Measure
Robot Guided
n=389 Participants
Robotically Guided Screw Placement
Navigated
n=198 Participants
Navigation Assisted Screw Placement
Freehand
n=315 Participants
Freehand Technique
Revision Surgery for a Malpositioned Pedicle Screw
4 Patients
7 Patients
4 Patients

SECONDARY outcome

Timeframe: Intraoperative

Revision or redirection of a placed screw during the same general anesthesia session

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Intraoperative

Duration of Surgery in minutes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through hospital stay (From admission to discharge of the hospital stay in which the primary surgery was carried out)

Length of Hospital Stay in days (Defined as from admission to discharge, during the hospital stay in which the primary surgery was carried out)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Intraoperative

Radiation Dose as DAP (Dose Area Product, cGy cm2)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Intraoperative

Estimated Blood Loss (ml)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through hospital stay (From admission to discharge of the hospital stay in which the primary surgery was carried out)

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0 weeks

Intraoperative Complications

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Postoperative Complications

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Oswestry Disability Index (ODI) for functional impairment

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Frequency of use of analgetics (daily/weekly/not regularly)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Satisfaction with symptoms (satisfied/neutral/dissatisfied)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Smoking status (active/ceased/never)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Working status (able to work/unable to work)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Return to work (number of weeks/not yet)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks

Overall rate of reoperations

Outcome measures

Outcome data not reported

Adverse Events

Robot-Guided Transpedicular Instrumentation

Serious events: 4 serious events
Other events: 41 other events
Deaths: 1 deaths

Navigated Transpedicular Instrumentation

Serious events: 7 serious events
Other events: 47 other events
Deaths: 11 deaths

Freehand Transpedicular Instrumentation

Serious events: 4 serious events
Other events: 51 other events
Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure
Robot-Guided Transpedicular Instrumentation
n=389 participants at risk
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). Transpedicular Instrumentation: Transpedicular screw placement and instrumentation
Navigated Transpedicular Instrumentation
n=198 participants at risk
This arm will comprise all patients that receive transpedicular instrumentation by use of navigation (computer assistance using CT, O-arm or 3D-fluoroscopic imaging). Transpedicular Instrumentation: Transpedicular screw placement and instrumentation
Freehand Transpedicular Instrumentation
n=315 participants at risk
This arm will comprise all patients that receive transpedicular instrumentation by use of the conventional freehand technique. Transpedicular Instrumentation: Transpedicular screw placement and instrumentation
Musculoskeletal and connective tissue disorders
Revision Surgery for Malposition/Loosening
1.0%
4/389 • 1 year
3.5%
7/198 • 1 year
1.3%
4/315 • 1 year

Other adverse events

Other adverse events
Measure
Robot-Guided Transpedicular Instrumentation
n=389 participants at risk
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). Transpedicular Instrumentation: Transpedicular screw placement and instrumentation
Navigated Transpedicular Instrumentation
n=198 participants at risk
This arm will comprise all patients that receive transpedicular instrumentation by use of navigation (computer assistance using CT, O-arm or 3D-fluoroscopic imaging). Transpedicular Instrumentation: Transpedicular screw placement and instrumentation
Freehand Transpedicular Instrumentation
n=315 participants at risk
This arm will comprise all patients that receive transpedicular instrumentation by use of the conventional freehand technique. Transpedicular Instrumentation: Transpedicular screw placement and instrumentation
Surgical and medical procedures
Surgical Complications
10.5%
41/389 • 1 year
23.7%
47/198 • 1 year
16.2%
51/315 • 1 year

Additional Information

Victor Staartjes

University Hospital Zurich

Phone: +41 44 255 2660

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place