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NCT04775537Recruiting

OssiMend BA in Posterolateral Instrumented Lumbar Fusion

Collagen Matrix

Start Date

1/21/2021

Completion Date

1/30/2027

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

Detailed Description

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. The primary endpoints are radiographic evidence of fusion and the absence of serious adverse events attributable to OssiMend Bioactive Moldable. The secondary objective is to evaluate the clinical outcomes over a period of 1 year (2 years, if possible).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Criteria: 1. Subject is under 18 years of age at the time of consent 2. Subject has had prior lumbar spine fusion surgery at any level 3. Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy 4. Subject is pregnant or nursing or planning to become pregnant during the two years (24 months) following arthrodesis 5. Subject has an active (local or systemic) infection or is undergoing adjunctive treatment for infection 6. Subjects under workers compensation or active litigation

Interventions

DEVICE

OssiMend™ Bioactive Moldable

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Conditions

Spinal DiseaseDegenerative Disc Disease

Locations

San Diego Neurosurgery

Encinitas, California 92024

United States

Hartford Hospital

Hartford, Connecticut 06102

United States

University Orthopaedic Associates, Division of OrthoNJ

Somerset, New Jersey 08873

United States

McKenzie-willamette Medical Center

Eugene, Oregon 97401

United States