Robotic-Assisted Pedicle Screw Placement in Spine Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robotic-assisted pedicle screw placement.
- Who it may be relevant to
- Registry conditions: Pedicle Screw Fixation of Spine. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ROBOTICSS - Robotic-Assisted Pedicle Screw Placement in Spine Surgery: A Multicenter Prospective Observational Study
Overview
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.
Detailed description
Pedicle screw fixation is widely used in spinal surgery. Screw misplacement may cause complications and reoperations. Robotic-assisted systems aim to improve accuracy and workflow; however, high-quality real-world evidence regarding long-term clinical outcomes and cost-effectiveness remains limited.
This nationwide cohort study includes consecutive patients undergoing spinal surgery with pedicle screws. Exposure is robotic-assisted versus non-robotic-assisted (navigation-assisted or freehand) screw placement. Data capture is made from registries, radiographs and hospital data. Follow-up is up to 2 years for the primary outcomes and up to 5 years for the secondary outcomes.
Interventions
- Device Robotic-assisted pedicle screw placement
Robotic-assisted pedicle screw placement using commercially available robotic systems
Primary outcome measures
- Proportion of patients in which at least one pedicle screw is not accurately placed (substudy 1) [Time frame: Periprocedural]
- Learning curve (substudy 2) [Time frame: Periprocedural]
- Reoperation rate at 2 years (substudy 3) [Time frame: From enrolment up until 2 years after surgery]
Secondary outcome measures (9)
- Screw placement precision [Time frame: Periprocedural]
- Length of stay [Time frame: Periprocedural]
- Time to return to work [Time frame: From surgery until 2 years after surgery]
- Health economic analysis [Time frame: From enrollment until the two-year follow-up]
- EQ-VAS [Time frame: At the one-year follow-up]
- EQ-5D [Time frame: At the one-year follow-up]
- Proportion of patients achieving the patient acceptable symptom state (PASS) for EQ-VAS [Time frame: At the one-year follow-up]
- Adverse events- thromboembolic and cardiovascular complications [Time frame: From enrolment until the 2 year follow-up]
- Adverse events- mortality [Time frame: From enrolment until the 2 year follow-up]
Eligibility criteria
Inclusion criteria
- Treatment with pedicle screws in the cervical, thoracic, lumbar spine and/or sacrum.
- All ages and spinal diagnoses
Exclusion criteria
- Treatment without pedicle screws
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 9 centers
- Sahlgrenska university hospital — Gothenburg
- Ryhov hospital — Jönköping
- Länssjukhuset Kalmar — Kalmar
- University Hospital Linköping — Linköping
- Örebro University Hospital — Örebro
- Karolinska University Hospital — Stockholm
- South General Hospital (Södersjukhuset) — Stockholm
- Umeå University Hospital — Umeå
- … and 1 more center
Identifiers
NCT: NCT07461636 · ROBOTICSS, protocol vers.1.01