Spine FusionNCT02611479

Understanding Non-Response in Spine Fusion Surgery

An observational study of Spine Fusion, run by University of Washington at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Spine Fusion
How many people: 184 participants
Where: 4 sitesUnited States
Study dates: Apr 2015to Jun 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adults (18 and over) undergoing spine fusion surgery in Washington State.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

University of Washington
Seattle, Washington, 98105
Proliance Surgeons
Seattle, Washington, 98122
Swedish Medical Center
Seattle, Washington, 98122
Confluence Health
Wenatchee, Washington, 98801

Other trials in United States

About this study

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

Conditions: Spine Fusion
Keywords: patient reported outcomes

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 60 day, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Jun 2018

First posted20 Nov 2015 (estimated)
Study startApr 2015
Primary completionAug 2017
Study completionJun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Spine FusionStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02611479
Sponsor's protocol ID: STUDY00001700
Other IDs: R21AR068009
Status last verified: May 2019
First submitted: 18 Nov 2015
Last updated: 30 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices
Fusion of Spine, Sacroiliac; Fusion
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Recruiting
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Lumbar Spine Degeneration, Lumbar Spine Instability
Recruiting
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Degenerative Spine Disease

All Spine Fusion trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Understanding Non-Response in Spine Fusion Surgery
ClinicalTrials.gov ID: NCT02611479
Acronym / sponsor ID: STUDY00001700
Conditions: Spine Fusion
Keywords: patient reported outcomes
Study type: Observational
Recruitment status: Completed
Enrolment: 184 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study start: Apr 2015 (actual)
Primary completion: Aug 2017 (actual)
Study completion: Jun 2018 (actual)
First posted: 20 Nov 2015 (estimated)
Results: Posted 30 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adults (18 and over) undergoing spine fusion surgery in Washington State.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

Results and safety

Results posted to the registry on 30 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spine Fusion Participants	184	171

Primary outcome: Oswestry Disability Index

Time frame: Baseline, 60 day, 1 year. Mean (Standard Deviation). Unit: score on a scale

Measure	Spine Fusion Participants n = 140
Baseline	41.3 (15.4)
60-day	30.4 (17.1)
12-month	19.4 (17.3)

Population analysed: 140 participants out of the 149 baseline participant population were analyzed since 9 participants were excluded due to incomplete Oswestry Disability Index data.

Adverse events

Time frame: Adverse Events not tracked and are inapplicable to this study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spine Fusion Participants	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Spine Fusion

RecruitingObservational study
Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices
Fusion of Spine, Sacroiliac; Fusion
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Recruiting
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Lumbar Spine Degeneration, Lumbar Spine Instability
Recruiting
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Degenerative Spine Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amy M Cizik, MPH, PhC study director

University of Washington

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Spine Fusion, run by University of Washington at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oswestry Disability Index (time frame: Baseline, 60 day, 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02611479.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.