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

Not Applicable

Recruiting

Conditions: Diseases of the musculo-skeletal system and connective tissue

Registration Number: KCT0000993

Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

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

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures