By InvitationNot Applicable

A Prospective Analysis of the Efficacy of Allosync Expand and Autograft Bone Graft in Open Lumbar Spinal Fusion

United States40 participantsStarted 2024-06-05

Plain-language summary

The purpose of this study is to assess the radiographic and clinical outcomes of spinal fusion following use of Allosync Expand and autograft bone graft.

Who can participate

Age range22 Years

SexALL

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Inclusion criteria

✓. At least 22years of age at the time of consent
✓. Subject must have a documented diagnosis of spondylolisthesis up to Grade I. and have confirmed back and/or radicular pain with associated spinal stenosis as documented by conditions such as:
✓. Instability as defined by \>3mm translation or \>5 degree angulation
✓. Osteophyte formation of facet joints or vertebral endplates
✓. Subject presents with one or more of the following:
✓. Radiculopathy
✓. Sensory deficit
✓. Motor weakness

Exclusion criteria

✕. Subject has had prior lumbar spine fusion surgery at any level.
✕. Subject has greater than grade 1 spondylolisthesis of the lumbar spine.
✕. Subject is pregnant or nursing or planning to become pregnant during the two years (24 months) following arthrodesis
✕. Subject has an active local or systemic infection.
✕. Subject is a prisoner
✕. Patient has any condition (including malignancy), that in the opinion of the Investigator, would prohibit the patient from complying with and/or completing the protocol

What they're measuring

Lumbar fusion rate assessed via CT

Timeframe: 12 months post surgery

Trial details

NCT IDNCT06415110

SponsorResearch Source

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Spondylolisthesis, Grade 1 trials