RecruitingNCT04775537

OssiMend BA in Posterolateral Instrumented Lumbar Fusion

OssiMend Bioactive Moldable in Posterolateral Instrumented Lumbar Fusion

Sponsor

Collagen Matrix

Enrollment

120 participants

Start Date

Jan 21, 2021

Study Type

OBSERVATIONAL

Conditions

Degenerative Disc Disease Spinal Disease

Summary

The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Subject must be 18 years of age or older at the time of consent and must have a documented diagnosis of degenerative disc disease (DDD) that has failed to respond to nonoperative treatment for at least 6 months. DDD is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings:
Instability as defined by \>3mm translation or \>5 degrees angulation
Osteophyte formation of facet joints or vertebral endplates
Decreased disc height, on average by \>2mm, but dependent upon the spinal level
Herniated nucleus pulposus
Facet joint degeneration/changes

Exclusion Criteria6

Subject is under 18 years of age at the time of consent
Subject has had prior lumbar spine fusion surgery at any level
Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy
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 or is undergoing adjunctive treatment for infection
Subjects under workers compensation or active litigation

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