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Completed

NCT Number: NCT00679107

A Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions

This study will explore the use of OP-1 Putty in conjunction with surgical treatment for the treatment of spinal decompression and lumbar spinal fusion.

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Key information

Conditions

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

Age range

18 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Haven, Connecticut, United States

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About this study

It is postulated that the addition of OP-1 Putty to autogenous bone will prove beneficial in the treatment of patients requiring decompression and lumbar spinal fusion. The Investigational system is intended to stimulate bone growth. It is indicated as an adjunct or a replacement for autograft in spinal fusion.

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

Use of OP-1 Putty in Uninstrumented posterolateral fusion

Device

Use of OP-1 Putty in Uninstrumented posterolateral fusion

Other names: Uninstrumented posterolateral fusion

Primary outcomes

  1. Safety, by comparison of the complications and neurological status within the OP-1treatment groups and the control group (autograft alone).

    Time frame: 6 weeks; 3, 6, 9, 12, and 24 months

Secondary outcomes

  1. Efficacy, by comparison of overall fusion success and time to fusion along with pain / function outcome within the OP-1 treatment groups and the control group (autograft alone).

    Time frame: 6 weeks; 3, 6, 9, 12, and 24 months

Sponsors and collaborators

Lead sponsor

Olympus Biotech Corporation

Industry

Registry information

Official study title

A Prospective, Randomized, Controlled, Multicenter, Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions

Important dates

Study start
1999
Primary completion
2000
Study completion
2005
First posted
May 16, 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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