Robotic-Assisted Surgery in Treating Patients With Spine Tumors

City of Hope Medical Center

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Adult Spinal Cord Neoplasm Spinal Bone Metastases Spinal Cord Metastases

Interventions

therapeutic conventional surgeryPROCEDURE

Undergo robotic-assisted surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Complication rates with 95% confidence bounds of +/- 31% or smaller

Time frame: For 100 days post-surgery

Estimated blood loss

Time frame: For 100 days post-surgery

Operation duration

Time frame: At the completion of surgery

Complication rate

Time frame: For 100 days post-surgery

Demographic and clinical data such as stage, grade and histology

Time frame: At baseline

Data from ClinicalTrials.gov

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