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Clinical Trials in the USA / NCT04775537
Recruiting Observational

OssiMend BA in Posterolateral Instrumented Lumbar Fusion

NCT04775537 · tracked via the Priya Life Science USA tracker
Sponsor
Collagen Matrix
Phase
Observational
Started
2021-01-21
Last updated
2025-10-16

Condition(s) studied

Spinal DiseaseDegenerative Disc Disease

Investigational drug(s) / intervention(s)

OssiMend™ Bioactive Moldable

OssiMend™ Bioactive Moldable: Lumbar Spine fusion with OssiMend™ Bioactive Moldable

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
San Diego Neurosurgery Encinitas California Not Yet Recruiting
Hartford Hospital Hartford Connecticut Recruiting
University Orthopaedic Associates, Division of OrthoNJ Somerset New Jersey Not Yet Recruiting
McKenzie-willamette Medical Center Eugene Oregon Completed

More Collagen Matrix trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04775537 on ClinicalTrials.gov ↗ ← All trials in the USA