Robotic-Assisted Pedicle Screw Placement in Spine Surgery

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

ROBOTICSS - Robotic-Assisted Pedicle Screw Placement in Spine Surgery: A Multicenter Prospective Observational Study

ClinicalTrials.gov ID

NCT07461636

Acronym / sponsor ID

ROBOTICSS / ROBOTICSS, protocol vers.1.01

Conditions

Pedicle Screw Fixation of Spine

Keywords

Robotic assisted, Pedicle screws, Spinal implants, Spinal disorder, Spine, Surgery, Surgical technique

Study type

Observational

Recruitment status

Recruiting

Enrolment

7,200 participants (estimated)

Lead sponsor

Uppsala UniversityUniversity, hospital or other

Collaborators

Uppsala University Hospital, Ôrebro University Hospital, Umeå University, University Hospital, Umeå, Karolinska Institutet, Karolinska University Hospital, Stockholm South General Hospital, Sahlgrenska University Hospital, University of Linköping, University Hospital, Linkoeping, Lund University, Skane University Hospital, Länssjukhuset Ryhov, Länssjukhuset Kalmar, Örebro University, Sweden, Göteborg University

Study start

2 Feb 2026 (actual)

Primary completion

2 Feb 2032 (estimated)

Study completion

2 Feb 2035 (estimated)

First posted

10 Mar 2026 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Target follow-up

5 Years

Number of arms

2

Who may qualify

Sex

All

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

Study population

Swedish residents undergoing spine surgery in Sweden

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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

   Time frame: Periprocedural

   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.

2. Learning curve (substudy 2)

   Time frame: Periprocedural

   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.

3. Reoperation rate at 2 years (substudy 3)

   Time frame: From enrolment up until 2 years after surgery

   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).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
• Individual participant dataSharing planned: No. 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

9 sites in 1 country: see every site and its status.