Minimally Invasive Surgery (MIS) for Spine Metastases

NCT ID: NCT02367378

Last Updated: 2017-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-06-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spine Metastases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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MIS

Those who received minimally invasive surgical procedures

No interventions assigned to this group

Control

Those who received treatments which include surgical resection, chemotherapy, and radiotherapy.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* undergone minimally invasive surgery
* over 18 years of age

Exclusion Criteria

* unable to give consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arthur Jenkins, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GCO 12-0161

Identifier Type: -

Identifier Source: org_study_id

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