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OpenTrials
Completed

NCT Number: NCT02611479

Understanding Non-Response in Spine Fusion Surgery

To identify patient characteristics associated with non-response after spine fusion surgery for the treatment of degenerative disc disease (DDD).

Completed

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Key information

Conditions

Spine Fusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Proliance Surgeons, Seattle, Washington, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject has diagnosis of degenerative disc disease
  • Subject is undergoing lumbar spine fusion surgery

Exclusion criteria

  • Subject is less than 18 years of age
  • Subject is not fluent in English
  • Subject requires a caretaker for medical decision making

Treatment and study plan

Primary outcomes

  1. Oswestry Disability Index

    Time frame: Baseline, 60 day, 1 year

    Change in pain and function after spine fusion surgery was measured by the Oswestry Disability Index. Scores range from 0 to 100.

    The questionnaire has 10 questions about pain intensity, personal care, lifting ability, walking ability, sitting ability, standing ability, sleeping ability, sex ability, social life, and travelling. Each question is followed by 6 options which describe the amount of disability a patient may face in these situations and the patient marks the statement most applicable to them. Each question is scored on a scale (0-5) with the first option "0" indicating the least amount of disability and "5" indicating the most severe disability. Higher scores indicate worse outcomes, lower scores indicate better outcomes.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Nov 20, 2015
Registry last updated
May 30, 2019

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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