Robotic-Assisted Surgery in Treating Patients With Spine Tumors

Study Overview
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Brief Summary
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This pilot clinical trial studies robotic-assisted surgery in treating patients with spine tumors. Robotic-assisted surgery is a less invasive type of surgery for spine tumors and may have fewer side effects and improve recovery

Detailed Description
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PRIMARY OBJECTIVES: I. To perform a small pilot study that will demonstrate the feasibility of neurosurgical spinal procedures using the da Vinci surgical robot. SECONDARY OBJECTIVES: I. To compare complication rates, operative time and estimated blood loss with historical controls. II. To observe wound healing, cerebrospinal fluid (CSF) leaks, neurological injury and hardware failure. II. Routine imaging of the spinal segment. OUTLINE: Patients undergo robotic-assisted surgery using the da Vinci robot. After completion of study treatment, patients are followed up for 100 days.

Official Title
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A Pilot Feasibility and Safety Study Using Robotic Assisted Surgery in Patients With Spine Tumors

Conditions
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Adult Spinal Cord Neoplasm, Spinal Bone Metastases, Spinal Cord Metastases

Intervention / Treatment
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* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has primary or secondary spine tumor based on computed tomography (CT) or magnetic resonance imaging (MRI) Karnofsky performance status (PS) of >= 80 or Eastern Cooperative Oncology Group (ECOG) PS 0-1 Expected survival greater than 3 months Patient must be able to understand and sign a study-specific informed consent form Exclusion Criteria: Previous surgery at that specific segment Radiation at that specific spinal segment within the last 2 months Karnofsky PS < 80 or ECOG PS > 1 Pregnancy (due to risk of anesthesia) The presence of medical conditions which contraindicate general anesthesia Unexplained fever or untreated, active infection Inability to obtain exposure to allow performance of the planned spine surgical procedure History of psychiatric condition or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (surgery)<br>Patients undergo robotic-assisted surgery using the da Vinci robot | Procedure: therapeutic conventional surgery<br>* Undergo robotic-assisted surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rates with 95% confidence bounds of +/- 31% or smaller |  | For 100 days post-surgery | 
| Estimated blood loss |  | For 100 days post-surgery | 
| Operation duration |  | At the completion of surgery | 
| Complication rate |  | For 100 days post-surgery | 
| Demographic and clinical data such as stage, grade and histology |  | At baseline |