OssiMend BA in Posterolateral Instrumented Lumbar Fusion
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
Interventions
OssiMend™ Bioactive Moldable
Conditions
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