NCT04775537 OssiMend BA in Posterolateral Instrumented Lumbar Fusion
| NCT ID | NCT04775537 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Collagen Matrix |
| Condition | Spinal Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-01-21 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2021-01-21 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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: 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04775537 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04775537 currently recruiting?
Yes, NCT04775537 is actively recruiting participants. Contact the research team at mpaliwal@collagenmatrix.com for enrollment information.
Where is the NCT04775537 trial being conducted?
This trial is being conducted at Encinitas, United States, Hartford, United States, Somerset, United States, Eugene, United States.
Who is sponsoring the NCT04775537 clinical trial?
NCT04775537 is sponsored by Collagen Matrix. The trial plans to enroll 120 participants.