OssiMend BA in Posterolateral Instrumented Lumbar Fusion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCollagen Matrix
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- OssiMend™ Bioactive Moldable
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov