Skip to main content
OpenTrials
Completed

NCT Number: NCT00678353

Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

This study is to provide additional data to support the safety and efficacy of OP-1 Putty as a replacement for autograft in patients undergoing posterolateral spinal fusion.

Completed

Looking for future studies?

Notify Me

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

Observational

Primary location

Halifax, Nova Scotia, Canada

Loading trial locations.

About this study

Follow-up study 06-UPLF-01 was a prospective collection of longer-term data on the patient population from pivotal study S01-01US, and was conducted to expand the information regarding efficacy, particularly with regard to radiographic assessment of fusion, as well as the longer-term safety of OP-1 Putty in uninstrumented posterolateral fusion (PLF) as compared to autograft

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patient was treated in Stryker Biotech clinical protocol S01-01US (Pivotal IDE study) and not a retreatment failure at the time of completion.
  • The patient or legal guardian is willing and able to understand, sign and date the study specific Patient Informed Consent.
  • The patient agrees to complete the necessary clinical and radiographic evaluations.

Exclusion criteria

  • There are no exclusion criteria for participation in this protocol.

Treatment and study plan

Primary outcomes

  1. Evidence of bone by CT scan

    Time frame: 3+ years post-treatment from the Pivotal study S01-01US

Secondary outcomes

  1. Re-assessments of all clinical parameters from S01-01US

    Time frame: 3+ years post-treatment from the Pivotal study S01-01US

Sponsors and collaborators

Lead sponsor

Olympus Biotech Corporation

Industry

Registry information

Official study title

Prospective Data Collection From the Stryker Biotech Pivotal IDE Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

Important dates

Study start
2007
Study completion
2007
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.