NCT00677950

Brief Summary

The trial was designed to demonstrate the comparability of the overall success rate in the OP-1 Putty treatment group to the autograft treatment group.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
336

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2001

Longer than P75 for not_applicable

Geographic Reach
2 countries

24 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

October 1, 2001

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2008

Completed
Last Updated

June 10, 2011

Status Verified

June 1, 2011

Enrollment Period

2.1 years

First QC Date

May 13, 2008

Last Update Submit

June 9, 2011

Conditions

Degenerative Lumbar Spondylolisthesis

Keywords

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

  • Overall success rate at 24 months in the OP-1 Putty and the autograft groups, radiographic demonstration of spinal fusion, ODI improvement of at least 20%, no revisions, removals or supplemental fixations

    3, 6, 12, 24 months

Secondary Outcomes (1)

  • The number of anticipated and unanticipated complications/AEs that occurred within the study population, Visual Analog Scale Results for Pain Assessment, Donor Site Pain, Medication Use

    3, 6, 12, 24 months

Study Arms (2)

1

EXPERIMENTAL

OP-1 Putty

Procedure: Spinal fusion

2

ACTIVE COMPARATOR

Autograft

Procedure: Spinal fusion

Interventions

Spinal fusionPROCEDURE

Surgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis

Also known as: Lumbar Spinal Fusion
12

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject has a diagnosis of Degenerative Lumbar Spondylolisthesis of Grade I or II with Spinal Stenosis demonstrated by medical history, physical examination a n d radiographic imaging.
  • The subject is a candidate for decompression and spinal fusion with the use of autograft from the iliac crest.
  • The subject requires one level lumbar fusion (L-3 to S-1).
  • The subject has a preoperative Oswestry Disability Index of 30-100.

You may not qualify if:

  • The subject has active spinal and/or systemic infection.
  • The subject is morbidly obese.
  • The subject has a known sensitivity to any component of the OP-1 Putty.
  • The subject has spinal instability measured on flexion / extension radiographs of greater than 50% translation of the vertebrae and greater than or equal to 20 degrees of angular motion.
  • The subject uses tobacco or nicotine or is prescribed steroids such as cortisone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Unknown Facility

Santa Monica, California, United States

Location

Unknown Facility

Stanford, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Newark, Delaware, United States

Location

Unknown Facility

Clearwater, Florida, United States

Location

Unknown Facility

Fort Lauderdale, Florida, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Kalamazoo, Michigan, United States

Location

Unknown Facility

Southfield, Michigan, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Akron, Ohio, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Germantown, Tennessee, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Charlottesville, Virginia, United States

Location

Unknown Facility

Fairfax, Virginia, United States

Location

Unknown Facility

Halifax, Nova Scotia, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Spinal Fusion

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

ArthrodesisOrthopedic ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 13, 2008

First Posted

May 15, 2008

Study Start

October 1, 2001

Primary Completion

November 1, 2003

Study Completion

November 1, 2005

Last Updated

June 10, 2011

Record last verified: 2011-06

Locations

CA(3)US(21)