Prospective randomized controlled trial of minimally invasive robotic- vs. fluoroscopic-assisted open pedicle screw placement in adult degenerative spinal fusion surgeries

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000993

Enrollment

Registered

2014-01-23

Start date

2013-12-13

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : Robot group : Patients will be selected to participate in the study according to the inclusion/exclusion criteria listed below. Patients will be randomly selected i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients (age from 21 years), undergoing thoracic or lumbar or lumbosacral spinal fixation surgery. 2. Include spinopelvic fusion surgeries involving iliac screws, although these screws will not be included in the data analysis. 3. Primary surgery only 4. Patient capable of complying with study requirements 5. Signed informed consent of patient or legal guardian

Exclusion criteria

Exclusion criteria: 1. Infection or malignancy 2. Primary abnormalities of bones (e.g. osteogenesis imperfecta, congenital or idiopathic spinal deformities) 3. Primary muscle diseases, such as muscular dystrophy 4. Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma) 5. Spinal cord abnormalities with any neurologic symptoms or signs 6. Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia 7. Paraplegia 8. Patients requiring anterior release or instrumentation 9. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study. 10. Patient cannot follow study protocol, for any reason 11. Patient (or legal guardian, when applicable) cannot or will not sign informed consent

Design outcomes

Primary

Measure	Time frame
Pedicle screw instrumentation accuracy scored using the Gertzbein-Robbins classification of postoperative CTs in a subset of patients;Clinical outcome;Complications;Radiation dose/time	—

Secondary

Measure	Time frame
Clinical performance of instrumentation technique ;Hospital days	—

Countries

Korea, Republic of

Contacts

Public ContactSeung-Jae Hyun

Seoul National University Bundang Hospital

Outcome results