NCT01045473

Brief Summary

The population of the US is aging. They remain more active and place greater demands on their musculoskeletal system. A key problem is that pain and disability of age related spinal disorders will increase. Problems such as Degenerative Lumbar Spondylolisthesis, Degenerative Disk Disease, Spinal Stenosis and Degenerative Scoliosis are age related problems that are treated with spinal fusion when non-operative treatment fails. Traditional open surgery poses significant risk for patients in this age group. The use of minimally invasive spinal surgery techniques provides an opportunity to treat these patients with less morbidity than traditional open 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
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

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

Study Start

First participant enrolled

January 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

January 11, 2010

Status Verified

January 1, 2010

Enrollment Period

2 years

First QC Date

January 7, 2010

Last Update Submit

January 8, 2010

Conditions

Degenerative Disk DiseaseSpondylolisthesisSpinal StenosisDegenerative Scoliosis

Keywords

MISMinimally Invasive Spine SurgeryFusionSpineSMISS

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Orthropedic surgeon's clinic. Neurosurgeon's clinic.

You may qualify if:

  • Patient age 21 - 90 years.
  • Diagnosis of Spondylolisthesis, degenerative disk disease, and degenerative scoliosis (any curve magnitude).
  • A spinal fusion is being undertaken via the minimally invasive approach.
  • The patient agrees to follow-up for routine care for at least 2 years post-operatively.

You may not qualify if:

  • Inability for post-operative follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

SpondylolisthesisSpinal Stenosis

Condition Hierarchy (Ancestors)

SpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 7, 2010

First Posted

January 11, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2012

Study Completion

June 1, 2012

Last Updated

January 11, 2010

Record last verified: 2010-01