Robotic-Assisted Surgery in Treating Patients With Spine Tumors

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.

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