Adult Spinal Cord Neoplasm, Spinal Bone Metastases, Spinal Cord Metastases
Conditions
Brief summary
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
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.
Interventions
PROCEDUREtherapeutic conventional surgery
Undergo robotic-assisted surgery
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Outcome results
None listed