NCT01220921

Brief Summary

The creation of a multi-center cooperative research group encompassing academic and community-based spinal practices . . .

Trial Health

90
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2010

Geographic Reach
2 countries

13 active sites

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, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

1 year

First QC Date

October 13, 2010

Last Update Submit

December 3, 2015

Conditions

Symptomatic Lumbar Disc HerniationSymptomatic Grade I Lumbar Spondylolisthesis

Outcome Measures

Primary Outcomes (2)

  • SF-36 version 1

    Health-realted quality of life outcome measure

    1-Year

  • Site and Physician Compliance

    Goal = 80% compliance in enrolling 20 patients over 1 year with completed outcomes instruments

    1 Year

Secondary Outcomes (5)

  • Oswestry Disability Index (ODI)

    1 Year

  • Visual Analog Pain Score

    1 Year

  • Return to Work

    1 Year

  • 30 day complications

    30 days

  • Delayed Surgical Complications

    1 year

Study Arms (2)

Lumbar Microdiscectomy

EXPERIMENTAL

Patients aged 18-80 with symptomatic lumbar disc herniation resulting in single nerve root compression recalcitrant to non-invasive therapies for at least 6 weeks

Procedure: Lumbar Discectomy

Single-Level Lumbar Fusion

EXPERIMENTAL

Patients aged 18-80 with symptomatic grade I degenerative or isthmic spondylolisthesis with mechanical back pain with or without radiculopathy recalcitrant to non-invasive therapies for at least 3 months

Procedure: Single-level lumbar fusion

Interventions

Lumbar DiscectomyPROCEDURE

Microsurgical removal of disc that is compressing a nerve root

Lumbar Microdiscectomy
Single-level lumbar fusionPROCEDURE

pedicle screws with arthrodesis as directed by surgeon. Fusion can be posterolateral, interbody, or both.

Single-Level Lumbar Fusion

Eligibility Criteria

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

You may qualify if:

  • Grade I degenerative or isthmic spondylolisthesis recalcitrant to non-invasive therapies for at least 3 months or Lumbar degenerative disc herniation with radiculopathy refractory to non-invasive therapies for at least 6 weeks

You may not qualify if:

  • History of previous lumbar spine surgery
  • Significant motor weakness (3/5) (i.e. foot drop)
  • Cancer, infection, or fracture
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of California - San Francisco

San Francisco, California, 94143, United States

Location

Greenwich Hospital

Greenwich, Connecticut, 06830, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

University of Medicine and Dentistry - New Jersey

Newark, New Jersey, 07103, United States

Location

Columbia University - Neurological Institute

New York, New York, 10032, United States

Location

Carolina Spine

Charlotte, North Carolina, 28204, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

University of Calgary - Alberta Health Sevices

Calgary, Alberta, T2N-2T9, Canada

Location

Study Officials

  • Zoher Ghogawala, MD FACS

    Yale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2010

First Posted

October 14, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2012

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations

US(12)CA(1)