Understanding Non-Response in Spine Fusion Surgery
2 other identifiers
observational
184
1 country
4
Brief Summary
To identify patient characteristics associated with non-response after spine fusion surgery for the treatment of degenerative disc disease (DDD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2015
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 18, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedResults Posted
Study results publicly available
May 30, 2019
CompletedMay 30, 2019
May 1, 2019
2.3 years
November 18, 2015
December 17, 2018
May 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
Adults (18 and over) undergoing spine fusion surgery in Washington State.
You may qualify if:
- Subject has diagnosis of degenerative disc disease
- Subject is undergoing lumbar spine fusion surgery
You may not qualify if:
- Subject is less than 18 years of age
- Subject is not fluent in English
- Subject requires a caretaker for medical decision making
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Washington
Seattle, Washington, 98105, United States
Proliance Surgeons
Seattle, Washington, 98122, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Confluence Health
Wenatchee, Washington, 98801, United States
Related Links
Limitations and Caveats
Clinical variables were collected from SCOAP which is a quality improvement database and variables are not as reliable as research variables. It is unknown if participants that did not complete the surveys would have responded to surgery or not.
Results Point of Contact
- Title
- Dr. Amy Cizik - Research Assistant Professor, Ph.D., M.P.H.,
- Organization
- Surgical Outcomes Research Center - SORCE
Study Officials
- STUDY DIRECTOR
Amy M Cizik, MPH, PhC
University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director, Surgical Outcomes Research Center
Study Record Dates
First Submitted
November 18, 2015
First Posted
November 20, 2015
Study Start
April 1, 2015
Primary Completion
August 1, 2017
Study Completion
June 1, 2018
Last Updated
May 30, 2019
Results First Posted
May 30, 2019
Record last verified: 2019-05