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OpenTrials
Completed

NCT Number: NCT02367378

Minimally Invasive Surgery (MIS) for Spine Metastases

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.

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Key information

Conditions

Spine Metastases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • undergone minimally invasive surgery
  • over 18 years of age

Exclusion criteria

  • unable to give consent

Treatment and study plan

Primary outcomes

  1. Survival time

    Time frame: up to 2 years

    Survival time in days

Secondary outcomes

  1. Ambulation Index

    Time frame: up to 2 years

    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).

  2. Cobb Angle

    Time frame: up to 2 years

    The Cobb angle is used to quantify the magnitude of spinal deformities.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Minimally Invasive Surgery for Spine Metastases - A Prospective Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 20, 2015
Registry last updated
Jun 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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