Understanding Non-Response in Spine Fusion Surgery

Spine Fusion Clinical Trial

Official title:

Understanding Non-Response in Spine Fusion Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02611479
• Other study ID #: STUDY00001700
• Secondary ID: R21AR068009
• Status: Completed
• Start date: April 2015
• Est. completion date: June 2018

Study information

• Verified date: May 2019
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: June 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spine Fusion

Locations

Country	Name	City	State
United States	Proliance Surgeons	Seattle	Washington
United States	Swedish Medical Center	Seattle	Washington
United States	University of Washington	Seattle	Washington
United States	Confluence Health	Wenatchee	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index	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.	Baseline, 60 day, 1 year

External Links

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