Robotic vs. Freehand Corrective Surgery for Pediatric Scoliosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

272 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2019-07-08

Brief Summary

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To compare the accuracy and feasibility, curvature correction and clinical outcomes of pedicle screw instrumentation with versus without robotic guidance, in pediatric and adolescent scoliosis patients

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Detailed Description

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Conditions

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Scoliosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Arm 1: Robotic-guided, open approach

Robotic-guided, open approach

No interventions assigned to this group

Arm 2: control arm- non-robotic, open approach

control arm- non-robotic, open approach°

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Pediatric/adolescent patients (age 10 to 21 years), undergoing a primary surgery for the correction of a scoliotic curve of 40 degrees or greater
2. Patient capable of complying with study requirements
3. Signed informed consent by patient

Exclusion Criteria

1. Scheuermann's disease
2. Infection or malignancy
3. Primary abnormalities of bones (e.g. osteogenesis imperfecta)
4. Primary muscle diseases, such as muscular dystrophy
5. Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
6. Spinal cord abnormalities with any neurologic symptoms or signs
7. Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
8. Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
9. Patients requiring anterior release or instrumentation
10. 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.
11. Pregnancy
12. Patient cannot follow study protocol, for any reason
13. Patient cannot or will not sign informed consent

Minimum Eligible Age

10 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No