OssiMend BA in Posterolateral Instrumented Lumbar Fusion
OssiMend Bioactive Moldable in Posterolateral Instrumented Lumbar Fusion
1 other identifier
observational
120
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2021
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2021
CompletedFirst Submitted
Initial submission to the registry
February 11, 2021
CompletedFirst Posted
Study publicly available on registry
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 30, 2027
October 16, 2025
January 1, 2025
5.9 years
February 11, 2021
October 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fusion Success
Fusion will be assessed with A/P and Lateral radiographs taken and scored with Lenke's classification of posterolateral fusion success
12 months
Secondary Outcomes (3)
Visual analog scale (VAS) of back and leg (left and right)
12 months
Oswestry Lower Back Pain Questionnaire
12 months
SF36
12 months
Study Arms (1)
OssiMend™ Bioactive Moldable
Patients undergoing Lumber Spine Fusion
Interventions
Lumbar Spine fusion with OssiMend™ Bioactive Moldable
Eligibility Criteria
Subjects 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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Collagen Matrixlead
Study Sites (4)
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2021
First Posted
March 1, 2021
Study Start
January 21, 2021
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
January 30, 2027
Last Updated
October 16, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share