Minimally Invasive Surgery in Treating Patients With Spinal Tumors

Not Applicable

Terminated

• Conditions: Spinal Cord Metastases; Recurrent Adult Spinal Cord Neoplasm; Adult Spinal Cord Neoplasm; Spinal Bone Metastases
• Interventions: Procedure: therapeutic conventional surgery; Procedure: quality-of-life assessment

• Registration Number: NCT01308489
• Lead Sponsor: City of Hope Medical Center

Brief Summary

This randomized clinical trial studies minimally invasive surgery in treating patients with spinal tumors. Posterior spinal tumor resection and anterior and posterior spinal tumor resection are less invasive types of surgery for spinal tumors and may have fewer side effects and improve recovery

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-02
• Study First Posted: 2011-03-04
• Study Start: 2012-05
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (anterior and posterior spinal tumor resection)	quality-of-life assessment	Patients undergo anterior and posterior tumor resection on day 0.
Arm I (posterior spinal tumor resection)	quality-of-life assessment	Patients undergo posterior spinal tumor resection on day 0.
Arm I (posterior spinal tumor resection)	therapeutic conventional surgery	Patients undergo posterior spinal tumor resection on day 0.
Arm II (anterior and posterior spinal tumor resection)	therapeutic conventional surgery	Patients undergo anterior and posterior tumor resection on day 0.

Primary Outcome Measures

Name	Time	Method
Complication rate	Day 0
Neurological preservation	Post operation day 90
Length of operation (OR time)	Day 0	Will be comparing means with the Wilcoxon test.
Estimated blood loss (EBL); in milliliters (ml)	Day 0	Will be comparing means with the Wilcoxon test.

Secondary Outcome Measures

Name	Time	Method
Length of stay	Less than 7 days
Evaluation of arthrodesis	Post-op day 1, 28, and 90	Plain x-ray films and CT scans are used to determine the success of arthrodesis (spinal fusion in this case) which is the artificial induction of joint ossification between two bones via surgery. This is done to relieve intractable pain in a joint which cannot be managed by pain medication.
Pain symptoms	Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90
Assessment of neurologic function using the ASIA (American Spinal Injury Association) Impairment Scale	Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90	This is an assessment of sensory and motor functions based upon the ASIA Impairment Scale

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States