An observational study in Spine Fusion, sponsored by University of Washington. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-30.
Sponsored by University of Washington · Observational
To identify patient characteristics associated with non-response after spine fusion surgery for the treatment of degenerative disc disease (DDD).
University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults (18 and over) undergoing spine fusion surgery in Washington State.
Exclusion Criteria:
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.
Time frame: Baseline, 60 day, 1 year
| Milestone | Spine Fusion Participants |
|---|---|
| Started | 184 |
| Completed | 171 |
| Not completed | 13 |
| Withdrew: Exited study | 13 |
| Milestone | Spine Fusion Participants |
|---|---|
| Started | 171 |
| Completed | 169 |
| Not completed | 2 |
| Withdrew: No surgery reported | 2 |
| Milestone | Spine Fusion Participants |
|---|---|
| Started | 169 |
| Completed | 151 |
| Not completed | 18 |
| Withdrew: Lost to follow-up | 18 |
| Milestone | Spine Fusion Participants |
|---|---|
| Started | 151 |
| Completed | 149 |
| Not completed | 2 |
| Withdrew: No baseline function or pain metrics | 2 |
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.
| score on a scale | Spine Fusion Participants |
|---|---|
| Baseline | 41.3 ± 15.4 |
| 60-day | 30.4 ± 17.1 |
| 12-month | 19.4 ± 17.3 |
Collected over Adverse Events not tracked and are inapplicable to this study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Spine Fusion Participants | — | — | — |
| Age, Categorical(Participants) | Spine Fusion Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 71 |
| >=65 years | 78 |
| Sex: Female, Male(Participants) | Spine Fusion Participants |
|---|---|
| Female | 83 |
| Male | 65 |
| Ethnicity (NIH/OMB)(Participants) | Spine Fusion Participants |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 144 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Spine Fusion Participants |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 140 |
| More than one race | 2 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Spine Fusion Participants |
|---|---|
| United States | 149 |
| Functional Limitations from back pain (ODI)(units on a scale) | Spine Fusion Participants |
|---|---|
| Mean | 41.3 ± 15.4 |
| Anxiety(T-scores) | Spine Fusion Participants |
|---|---|
| Mean | 55.0 ± 9.2 |
| Depression(T-scores) | Spine Fusion Participants |
|---|---|
| Mean | 52.5 ± 9.6 |
11 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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University of Washington