OssiMend BA in Posterolateral Instrumented Lumbar Fusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OssiMend™ Bioactive Moldable.
- Who it may be relevant to
- Registry conditions: Spinal Disease, Degenerative Disc Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
OssiMend Bioactive Moldable in Posterolateral Instrumented Lumbar Fusion
Overview
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).
Interventions
- Device OssiMend™ Bioactive Moldable
Lumbar Spine fusion with OssiMend™ Bioactive Moldable
Primary outcome measures
- Fusion Success [Time frame: 12 months]
Secondary outcome measures (3)
- Visual analog scale (VAS) of back and leg (left and right) [Time frame: 12 months]
- Oswestry Lower Back Pain Questionnaire [Time frame: 12 months]
- SF36 [Time frame: 12 months]
Eligibility criteria
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 4 centers
- San Diego Neurosurgery — Encinitas
- Hartford Hospital — Hartford
- University Orthopaedic Associates, Division of OrthoNJ — Somerset
- McKenzie-willamette Medical Center — Eugene
Identifiers
NCT: NCT04775537 · CIP.072.Spine Prospective