Minimally Invasive Surgery in Treating Patients With Spinal Tumors

PRIMARY OBJECTIVES:

I. Length of operation (operating room [OR] time). II. Estimated blood loss (EBL). III.
Complication rate. IV. Neurological preservation.

SECONDARY OBJECTIVES:

I. Motor strength and sensory level (neurological outcome). II. Bladder and bowel function.
III. Post-operative pain. IV. Hospital length of stay (recovery time). V. Arthrodesis.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo posterior spinal tumor resection on day 0.

ARM II: Patients undergo anterior and posterior spinal tumor resection on day 0.

After completion of study treatment, patients are followed up for 6 months.

Inclusion Criteria:

- Patients must have a diagnosis of primary, secondary or metastatic spine tumor and be
undergoing any posterior spinal fusion with or without anterior fusion anywhere from
occiput to sacrum

- Greater than 3 month life expectancy

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control or abstinence) prior to study entry and
for six months following duration of study participation; should a woman become
pregnant or suspect that she is pregnant while participating on the trial, she should
inform her treating physician immediately

- All subjects must have the ability to understand and the willingness to sign a
written informed consent

Exclusion Criteria:

- Patients who are not surgical candidates for spine tumor removal, determined by the
surgical team

- Patients who have undergone previous spine surgery for tumor removal will be excluded

- Patients with renal cell carcinoma. As there is an emphasis on blood loss and length
of surgery, the critical variable for homogeneity is the vascularity of the tumor;
hypervascular spine tumors are regarded by surgeons as amongst the most challenging
of cases; by far the three most common hypervascular metastatic tumors are those
arising from renal cell carcinoma, thyroid carcinoma and melanoma; these pathologies
are usually regarded as a distinct subset for this reason in the majority of studies;
because we rarely encounter the later two pathologies in our practice, we chose to
include only the former; however, to further homogenize our study population we will
exclude all three of the known hypervascular metastatic spine tumors

- Subjects, who in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study