Predictors of Decompressive Laminectomy Outcomes

NCT02215551 | Completed

• 1 other identifier: O0798-R
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 7

Brief Summary

Decompressive laminectomy (DL) is the most common type of back surgery performed in older adults; DL treats lumbar spinal stenosis (LSS), a degenerative narrowing of the spinal canal causes pain and trouble walking. An estimated one in three people who undergo DL do not get well and often undergo repeated surgery.1,3-6 Some studies indicate that conditions outside of the spine (e.g., depression, hip arthritis) cause people who undergo DL to do poorly,27,30-36 but no one has comprehensively examined these conditions or the impact of treating them on DL outcomes. Thus LSS treatment continues to focus on the spine alone.61 The aim of this study is to identify conditions other than LSS that place Veterans at risk of poor DL outcomes so that future comparative effectiveness studies can be designed that examine the impact of a more comprehensive approach to treatment. Investigators believe that a patient-centered rather than a disease-centered approach will lead to superior outcomes, less suffering, and more appropriate use of health care resources.

Conditions

Lumbar Spinal Stenosis

Keywords

laminectomy

Outcome Measures

Primary Outcomes (1)

• Brigham Spinal Stenosis Questionnaire

  The BSS has three scales that measure pain, function, and satisfaction. The pain and satisfaction scales can be administered before and after DL; the satisfaction scale measures satisfaction with surgery and is only administered following DL. Threshold values have been defined for success versus failure on each of the three subscales based on receiver operating characteristic (ROC) analyses - 0.46 for the Symptom Severity Scale, 0.42 for the Physical Function Scale, and 2.42 for the Patient Satisfaction Scale. The most balanced definition of overall success requires that the patient achieve success in at least two of the three scales. Investigators use this definition, which has the greatest sensitivity and specificity, as the primary outcome in our statistical analyses.

  1 Year

Other Outcomes (1)

• Goal Attainment Scaling (GAS)

  1 Year

Study Arms (1)

Study Group

Younger than 90 years old. no communication barriers (e.g., English speaking, household telephone) Affirmative response to each of the three following questions: a) Do patients have pain, weakness, numbness, or tingling in their legs when walking standing? b) Does this pain, weakness, numbness or tingling in their legs interfere with their daily activities? c) Have patients tried at least one non-surgical treatment for their leg symptoms (e.g., physical therapy, pain medications, spinal injection)? Have been scheduled for surgery on lower back for a condition called lumbar spinal stenosis. Whom have non degenerative causes of LSS such as tumor, infection, trauma, hemorrhage, or epidural lipomatosis, Prior lumbar spinal surgery, spondylolisthesis with spinal instability, significant cognitive impairment.

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

350 Veterans with degenerative lumbar spinal stenosis (LSS) who are scheduled to undergo decompressive laminectomy (DL) will be recruited. No one will be excluded on the basis of age, race, gender or ethnicity. There is no age restriction as investigators are targeting patients with degenerative lumbar spinal stenosis, most of who are in their 50's and 60's. Investigators exclude participants with non-degenerative causes of LSS, as noted below. Investigators anticipate that the demographics of the participants will reflect that of the three participating VA sites and their affiliated University spine surgery practices. Our goal is to recruit at least 70% Veteran participants and Investigators have added three additional VA sites that will help to ensure this.

You may qualify if:

• Younger than 90 years old.
• no communication barriers (e.g., English speaking, household telephone)
• Affirmative response to each of the three following questions:
• a) Do patients have pain, weakness, numbness, or tingling in their legs when walking standing?
• b) Does this pain, weakness, numbness or tingling in their legs interfere with their daily activities?
• c) Have patients tried at least one non-surgical treatment for their leg symptoms (e.g., physical therapy, pain medications, spinal injection)?
• Have been scheduled for surgery on lower back for a condition called lumbar spinal stenosis.

You may not qualify if:

• non degenerative causes of LSS such as
• tumor,
• infection,
• trauma,
• hemorrhage,
• or epidural lipomatosis
• Prior lumbar spinal surgery
• spondylolisthesis with spinal instability
• significant cognitive impairment

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (7)

VA Eastern Colorado Health Care System, Denver, CO

Denver, Colorado, 80220, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229, United States

Location

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Debra K. Weiner, MD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: August 13, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2022
• Study Completion: January 10, 2023
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)