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Completed

NCT Number: NCT00677950

OP-1 Putty for Posterolateral Fusions

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.

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Key information

Conditions

Degenerative Lumbar Spondylolisthesis Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Halifax, Nova Scotia, Canada

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About this study

A controlled, open- label, blinded radiographic assessment, randomized, prospective, multicenter, multinational pivotal study in which patients with single level (L3-S1) degenerative lumbar spondylolisthesis (Grade 1 or 2) with spinal stenosis underwent decompression and spinal fusion and received OP-1 Putty or autograft. This study was a one-sided, non- inferiority trial comparing the overall success between the OP-1 Putty group and the control autograft group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Spinal Fusion

Procedure

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

Other names: Lumbar Spinal Fusion

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

    Time frame: 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

    Time frame: 3, 6, 12, 24 months

Sponsors and collaborators

Lead sponsor

Olympus Biotech Corporation

Industry

Registry information

Important dates

Study start
2001
Primary completion
2003
Study completion
2005
First posted
May 15, 2008
Registry last updated
Jun 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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