## Protocol Section
### Identification Module
**NCT ID:** NCT02611479

**Brief Title:** Understanding Non-Response in Spine Fusion Surgery

**Official Title:** Understanding Non-Response in Spine Fusion Surgery

#### Organization Study ID Info
**ID:** STUDY00001700
#### Organization
**Class:** OTHER
**Full Name:** University of Washington
#### Secondary ID Infos
**ID:** R21AR068009
**Link:** https://reporter.nih.gov/quickSearch/R21AR068009
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2018-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2019-05-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-08

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-05-30

**Type:** ACTUAL

**Results First Submit Date:** 2018-12-17

**Results First Submit QC Date:** 2019-05-08

#### Start Date
**Date:** 2015-04

**Type:** ACTUAL

**Status Verified Date:** 2019-05

#### Study First Post Date
**Date:** 2015-11-20
**Type:** ESTIMATED
**Study First Submit Date:** 2015-11-18
**Study First Submit QC Date:** 2015-11-19
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Washington

#### Responsible Party

**Investigator Affiliation:** University of Washington

**Investigator Full Name:** David Flum

**Investigator Title:** Medical Director, Surgical Outcomes Research Center

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

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

### Conditions Module

**Conditions:**

- Spine Fusion

**Keywords:**

- patient reported outcomes

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 184

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Oswestry Disability Index

**Time Frame:** Baseline, 60 day, 1 year

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seattle

**Country:** United States

**Facility:** University of Washington

**State:** Washington

**Zip:** 98105

**Location 2:**

**City:** Seattle

**Country:** United States

**Facility:** Proliance Surgeons

**State:** Washington

**Zip:** 98122

**Location 3:**

**City:** Seattle

**Country:** United States

**Facility:** Swedish Medical Center

**State:** Washington

**Zip:** 98122

**Location 4:**

**City:** Wenatchee

**Country:** United States

**Facility:** Confluence Health

**State:** Washington

**Zip:** 98801

#### Overall Officials

**Official 1:**

**Affiliation:** University of Washington

**Name:** Amy M Cizik, MPH, PhC

**Role:** STUDY_DIRECTOR

### References Module

#### See Also Links

**Label:** Related Info

**URL:** http://www.becertain.org/

## Document Section

### Large Document Module

#### Large Docs

- Date: 2019-02-06

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 599588

- Type Abbrev: Prot

- Upload Date: 2019-05-08T18:48

- Date: 2019-02-06

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 327210

- Type Abbrev: SAP

- Upload Date: 2019-05-08T18:49

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Adverse Events not tracked and are inapplicable to this study.

#### Event Groups

**Group ID:** EG000

**Title:** Spine Fusion Participants

**Description:** Patients undergoing lumbar spine fusion surgery for any indication.

**ID:** EG000

**Title:** Spine Fusion Participants

**Frequency Threshold:** 0

**Time Frame:** Adverse Events not tracked and are inapplicable to this study.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Units:** Participants

### Group

**ID:** BG000

**Title:** Spine Fusion Participants

**Description:** Patients undergoing lumbar spine fusion surgery for any indication.

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 71

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 78

**Category Title:** >=65 years

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 83

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 65

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 148

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 144

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 5

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 140

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 2

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 149

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 15.4

**Value:** 41.3

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.2

**Value:** 55.0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.6

**Value:** 52.5

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 7.4

**Value:** 55.4

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** 1-3 months

#### Measurement

**Group ID:** BG000

**Value:** 4

**Category Title:** 3-6 months

#### Measurement

**Group ID:** BG000

**Value:** 19

**Category Title:** 6 months-1 year

#### Measurement

**Group ID:** BG000

**Value:** 39

**Category Title:** 1-5 years

#### Measurement

**Group ID:** BG000

**Value:** 51

**Category Title:** More than 5 years

#### Measurement

**Group ID:** BG000

**Value:** 35

**Category Title:** Missing

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 5.5

**Value:** 67.1

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 30

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** Not at all

#### Measurement

**Group ID:** BG000

**Value:** 38

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** To a slight degree

#### Measurement

**Group ID:** BG000

**Value:** 38

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** To a moderate degree

#### Measurement

**Group ID:** BG000

**Value:** 28

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** To a great degree

#### Measurement

**Group ID:** BG000

**Value:** 11

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** All the time

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 42

**Category Title:** Alcohol

#### Measurement

**Group ID:** BG000

**Value:** 27

**Category Title:** Cannabis Use: Score Recoded

#### Measurement

**Group ID:** BG000

**Value:** 80

**Category Title:** Missing

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 106

**Category Title:** No

#### Measurement

**Group ID:** BG000

**Value:** 37

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 6

**Category Title:** Missing

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 88

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 9

**Category Title:** Poor

#### Measurement

**Group ID:** BG000

**Value:** 43

**Category Title:** Fair

#### Measurement

**Group ID:** BG000

**Value:** 61

**Category Title:** Good

#### Measurement

**Group ID:** BG000

**Value:** 28

**Category Title:** Very good

#### Measurement

**Group ID:** BG000

**Value:** 8

**Category Title:** Excellent

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8.1

**Value:** 54.8

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8.8

**Value:** 55.2

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 112

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 149

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** There is 1 missing.
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 6
**Description:** Oswestry Low Back Pain Disability Index (ODI) Total Score Scale 0-100 Sub-Scale Measures (0-5) for each: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling.

Interpretation: Simply add up your points for each section and plug it in to the following formula in order to calculate your level of disability: point total / 50 X 100 = % disability (aka: 'point total' divided by '50' multiply by ' 100 = percent disability)

Lower values represent better outcomes. Higher values represent worse outcomes.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Functional Limitations from back pain (ODI)
**Unit of Measure:** units on a scale
### Measure 7
**Description:** PROMIS T Score: Total Anxiety Score 4 questions scaled 1-5 about anxiety, the raw score is the sum of these questions

Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered

The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant.

Lower values represent better outcomes. Higher values represent worse outcomes.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Anxiety
**Unit of Measure:** T-scores
### Measure 8
**Description:** PROMIS T Score: Total Depression Score 4 questions scaled 1-5 about depression, the raw score is the sum of these questions

Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered

The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant.

Lower values represent better outcomes. Higher values represent worse outcomes.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Depression
**Unit of Measure:** T-scores
### Measure 9
**Description:** PROMIS T Score: Total Sleep Disturbance Score 4 questions scaled 1-5 about sleep disturbance, the raw score is the sum of these questions

Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered

The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant.

Lower values represent worse outcomes. Higher values represent better outcomes.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Sleep
**Unit of Measure:** T-scores
### Measure 10
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Pain chronicity
**Unit of Measure:** Participants
### Measure 11
**Description:** PROMIS T Score: Total Pain Interference Score 4 questions scaled 1-5 about pain interference, the raw score is the sum of these questions

Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered

The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant.

Lower values represent better outcomes. Higher values represent worse outcomes.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Pain interference
**Unit of Measure:** T-scores
### Measure 12
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Pain catastrophizing (fear avoidance)
**Unit of Measure:** Participants
### Measure 13
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Alcohol, Marijuana Use
**Unit of Measure:** Participants
### Measure 14
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Asthma
**Unit of Measure:** Participants
### Measure 15
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Opioid/additional therapies use
**Unit of Measure:** Participants
### Measure 16
**Description:** PROMIS G02: general quality of life
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Global health
**Unit of Measure:** Participants
### Measure 17
**Description:** PROMIS T Score: Total Emotional Support Score 4 questions scaled 1-5 about emotional support, the raw score is the sum of these questions

Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered

The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant.

Lower values represent better outcomes. Higher values represent worse outcomes.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Emotional support
**Unit of Measure:** T-scores
### Measure 18
**Description:** PROMIS T Score: Total Instrumental Support Score 4 questions scaled 1-5 about instrumental support, the raw score is the sum of these questions

Formula: (Raw sum x number of items on the short form)/Number of items that were actually answered

The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant.

Lower values represent better outcomes. Higher values represent worse outcomes.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Instrumental support
**Unit of Measure:** T-scores
### Measure 19
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Radiculopathy
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** 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.
### Point of Contact
**Email:** amorgan2@uw.edu
**Organization:** Surgical Outcomes Research Center - SORCE
**Phone:** 206-744-4631
**Title:** Dr. Amy Cizik - Research Assistant Professor, Ph.D., M.P.H.,
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 15.4
- **Upper Limit:** 
- **Value:** 41.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 17.1
- **Upper Limit:** 
- **Value:** 30.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 17.3
- **Upper Limit:** 
- **Value:** 19.4
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 140 participants out of the 149 baseline participant population were analyzed since 9 participants were excluded due to incomplete Oswestry Disability Index data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 60 day, 1 year
**Title:** Oswestry Disability Index
**Type:** PRIMARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Patients undergoing lumbar spine fusion surgery for any indication.
**ID:** OG000
**Title:** Spine Fusion Participants
### Participant Flow Module
#### Group
**Description:** Patients undergoing lumbar spine fusion surgery for any indication.
**ID:** FG000
**Title:** Spine Fusion Participants
#### Period
**Title:** Baseline Enrollment
##### Withdraw
**Type:** Exited study
###### Reason
**Group ID:** FG000
**Number of Subjects:** 13
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 184
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 171
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 13
#### Period
**Title:** Post-Surgery Follow-up at 30-90 Days
##### Withdraw
**Type:** No surgery reported
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 171
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 169
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
#### Period
**Title:** Post-Surgery Follow-up at 1-Year
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 18
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 169
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 151
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 18
#### Period
**Title:** Data Cleaning
##### Withdraw
**Type:** No baseline function or pain metrics
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 151
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 149
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
**Pre-Assignment Details:** If participants did not complete a baseline survey before their lumbar spine fusion surgery or were found to be ineligible they were excluded from the study before completing follow-up surveys.
**Has Results:** True