NCT00555659

Brief Summary

Introduction: Degenerative changes of the discs and facet joints in the lumbar spine can result in pain and disability from spondylosis, spondylolisthesis and stenosis. Patients who are suffering with back and/or leg pain are potential candidates for an ALIF procedure. Purpose: To assess and compare clinical outcomes and fusion rates in patients undergoing an instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic categories. Comparisons between type of interbody spacer, graft type, and type of instrumentation will also be made

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 12, 2013

Status Verified

August 1, 2013

Enrollment Period

5.4 years

First QC Date

November 7, 2007

Last Update Submit

August 8, 2013

Conditions

DegenerationSpondylosisSpondylolithesisStenosis

Keywords

DegenerationSpondylosisSpondylolisthesisStenosis

Outcome Measures

Primary Outcomes (1)

  • Intake data will include all fields traditionally associated with a detailed note. Subsequent visit instruments will include visual analog scale and oswestry disability index.

    2 years

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any person who comes into the clinic and gives consent to participate in this prospective study.

You may qualify if:

  • Standard of care

You may not qualify if:

  • Standard of care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia Orthopaedic Group

Columbia, Missouri, 65201, United States

Location

MeSH Terms

Conditions

SpondylosisSpondylolisthesisConstriction, Pathologic

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysisPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • John D Miles, MD

    Columbia Orthopaedic Group, LLP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

November 7, 2007

First Posted

November 9, 2007

Study Start

September 1, 2007

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

August 12, 2013

Record last verified: 2013-08

Locations

US(1)