NCT00719485

Brief Summary

This study evaluated the hypothesis that the implementation of an educational program that informs spine patients about their condition, treatment options, prioritization on the wait list, and post-operative care would improve functional outcome and quality of life scores following surgery

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 6, 2009

Status Verified

July 1, 2008

Enrollment Period

1.8 years

First QC Date

July 17, 2008

Last Update Submit

February 5, 2009

Conditions

Decompression, Surgical

Keywords

lumbar decompression

Outcome Measures

Primary Outcomes (1)

  • Functional outcome scores

    2 years following surgery

Secondary Outcomes (1)

  • Quality of life scores

    2 years following surgery

Study Arms (2)

1

EXPERIMENTAL

Educational program

Other: Educational program

2

NO INTERVENTION

Standard care

Interventions

Educational programOTHER

Informing patients about their condition, treatment options, prioritization on the wait list, and post-operative care

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Degenerative condition of the lumbar spine requiring decompressive surgery

You may not qualify if:

  • emergent spinal condition
  • acute bowel/bladder dysfunction
  • cervical spine condition
  • inability to participate in follow up and/or functional tests or questionnaires during study timeline (due to substance abuse, etc...)
  • revision surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Albert Yee, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Albert Yee, MD

CONTACT

416-480-6815albert.yee@sunnybrook.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 21, 2008

Study Start

April 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 6, 2009

Record last verified: 2008-07