Minimally Invasive Surgery (MIS) for Spine Metastases

Spine Metastases Clinical Trial

Official title:

Minimally Invasive Surgery for Spine Metastases - A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367378
• Other study ID #: GCO 12-0161
• Status: Completed
• Phase: N/A
• First received: February 13, 2015
• Last updated: June 19, 2017
• Start date: February 2015
• Est. completion date: June 13, 2016

Study information

• Verified date: June 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect information on the effect of minimally invasive spine tumor decompression on treated patients. This treatment option is less invasive that the standard surgical decompression and is expected to result in better wound healing, decreased tissue trauma, and decreased pain after surgery.

Description:

This is a prospective study designed to analyze the impact that minimally invasive spine tumor decompression has upon quality of life, neurological morbidity, pain, and mortality. Prospective findings will be compared with historical controls to determine whether the minimally invasive approach offers better outcomes than traditional treatment methods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 13, 2016
• Est. primary completion date: June 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• undergone minimally invasive surgery

• over 18 years of age

Exclusion Criteria:

• unable to give consent

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spine Metastases

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival time	Survival time in days	up to 2 years
Secondary	Ambulation Index	Hauser Ambulation Index to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. Scores range from 0 (asymptomatic and fully active) to 10 (bedridden).	up to 2 years
Secondary	Cobb Angle	The Cobb angle is used to quantify the magnitude of spinal deformities.	up to 2 years