NCT07461636

Brief Summary

This prospective multicenter observational cohort study evaluates robotic-assisted pedicle screw placement compared with non-robotic-assisted techniques in spinal surgery. Primary objectives include screw placement accuracy, operative learning curve, and reoperation rate within 2 years.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
7,200

participants targeted

Target at P75+ for all trials

Timeline
106mo left

Started Feb 2026

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Feb 2026Feb 2035

Study Start

First participant enrolled

February 2, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2032

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2035

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

6 years

First QC Date

February 25, 2026

Last Update Submit

March 4, 2026

Conditions

Pedicle Screw Fixation of Spine

Keywords

Robotic assistedPedicle screwsSpinal implantsSpinal disorderSpineSurgerySurgical technique

Outcome Measures

Primary Outcomes (3)

  • Proportion of patients in which at least one pedicle screw is not accurately placed (substudy 1)

    Accurate screw placement is defined as a pedicle screw that remains entirely within the cortical boundary of the pedicle, or with up to 2 mm breach of the pedicle wall (corresponds to Gertzbein-Robbins Grade A and B), assessed on a computed tomography. To evaluate screw placement accuracy, we will define a binary per-patient outcome: whether at least one screw is not accurately placed. The planned sample size for this substudy is 75 patients in the robotic-assisted surgery group, and 426 patients in the non-robotic-assisted group, for a total of 501 patients. For this outcome, previously treated cases may be included as specified in the approved protocol.

    Periprocedural

  • Learning curve (substudy 2)

    To evaluate the learning curve associated with robotic-assisted surgery, we will model operative time as a function of case number. Operative time is expected to decrease with experience, then plateau. We will use mixed-effects piece-wise linear regression with the surgeon as a random effect to estimate the case number at which operative time levels off. The sample size in this substudy is 100 robotic-assisted spine surgeries in each of the 3 centers currently using robotic-assisted spine surgery (Umeå, Örebro, Uppsala), in total 300 surgeries. For this outcome, previously treated cases may be included as specified in the approved protocol.

    Periprocedural

  • Reoperation rate at 2 years (substudy 3)

    The primary outcome is the occurrence of reoperations of any cause within 2 years from the index surgery. The expected reoperation rate in the non-robotic group is likely to be higher than 3-5% over a 2-year period, and may in the robotic-assisted group be 1% or less. A difference of 2 percentage points or greater is considered clinically meaningful. Power analyses (80% power, alpha 0.05) have been made in two scenarios, with reoperation rates of 3% vs 1%, or 5% vs 3%. We estimate a ratio of 1:6 for robotic-assisted surgery vs navigation-assisted or free hand surgeries. Comparing 3% and 1% reoperation rates, 420 robotic-assisted surgery patients and 2,520 non-robotic surgery patients are needed (yielding a total sample size of 2,940 patients). In case reoperation rates are 5% and 3%, 866 robotic-assisted surgery patients and 5,196 non-robotic surgery patients are needed (yielding a total sample size of 6,062 patients).

    From enrolment up until 2 years after surgery

Secondary Outcomes (9)

  • Screw placement precision

    Periprocedural

  • Length of stay

    Periprocedural

  • Time to return to work

    From surgery until 2 years after surgery

  • Health economic analysis

    From enrollment until the two-year follow-up

  • EQ-VAS

    At the one-year follow-up

  • +4 more secondary outcomes

Study Arms (2)

Robotic-assisted pedicle screw placement

Robotic-assisted pedicle screw placement using commercially available robotic systems

Device: Robotic-assisted pedicle screw placement

Conventional pedicle screw placement

Conventional pedicle screw placement using navigation-assisted or freehand techniques

Interventions

Robotic-assisted pedicle screw placementDEVICE

Robotic-assisted pedicle screw placement using commercially available robotic systems

Robotic-assisted pedicle screw placement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Swedish residents undergoing spine surgery in Sweden

You may qualify if:

  • Treatment with pedicle screws in the cervical, thoracic, lumbar spine and/or sacrum.
  • All ages and spinal diagnoses

You may not qualify if:

  • Treatment without pedicle screws

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Sahlgrenska university hospital

Gothenburg, Sweden

RECRUITING

Ryhov hospital

Jönköping, Sweden

RECRUITING

Länssjukhuset Kalmar

Kalmar, Sweden

RECRUITING

University Hospital Linköping

Linköping, Sweden

RECRUITING

Örebro University Hospital

Örebro, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

South General Hospital (Södersjukhuset)

Stockholm, Sweden

RECRUITING

Umeå University Hospital

Umeå, Sweden

RECRUITING

Uppsala University Hospital

Uppsala, 75185, Sweden

RECRUITING

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Central Study Contacts

Paul Gerdhem, MD, PhD

CONTACT

+46(0)186110000paul.gerdhem@uu.se

Luigi Belcastro, RN

CONTACT

+46(0)184710000luigi.belcastro@uu.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 10, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

February 2, 2032

Study Completion (Estimated)

February 2, 2035

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data underlying the results reported in this study will not be publicly shared. Under Swedish law, registry-based health data are protected by the General Data Protection Regulation (GDPR). Sharing of individual-level data requires a valid ethical approval from the Swedish Ethical Review Authority and a formal data-sharing agreement with the data-holding authority. Researchers who obtain appropriate ethical approval and fulfill Swedish legal requirements may request access to relevant data from the responsible data controller. Such requests will be evaluated in accordance with national legislation and institutional policies. The study investigators will share aggregated results and statistical code upon reasonable request.

Locations

SE(9)