OssiMend BA for posterolateral instrumented lumbar fusion

OssiMend Bioactive Moldable in Posterolateral Instrumented Lumbar Fusion

This trial will try OssiMend Bioactive Moldable as the bone graft in adults having instrumented posterolateral lumbar fusion for degenerative disc disease to see if the spine fuses by 12 months.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Collagen Matrix (industry)
• Locations: 4 sites (Encinitas, California and 3 other locations)
• Trial ID: NCT04775537 on ClinicalTrials.gov

What this trial studies

This observational, multi-center study follows adults with degenerative disc disease who receive instrumented posterolateral lumbar arthrodesis using OssiMend Bioactive Moldable as the bone graft material. The primary outcome is the rate of radiographic fusion at 12 months combined with the absence of serious adverse events attributed to OssiMend. Secondary outcomes include clinical measures of pain and function tracked for one year (and up to two years if possible). Subjects must be 18 or older, have failed conservative care for at least six months, and have no prior lumbar fusion at any level.

Who should consider this trial

Good fit: Adults (18+) with degenerative disc disease who have failed nonoperative treatment for at least six months and are scheduled for instrumented posterolateral lumbar fusion, with no prior lumbar fusion, are ideal candidates.

Not a fit: Patients under 18, those with prior lumbar fusion at any level, or those currently receiving treatment for malignancy are not likely to benefit from participation.

Why it matters

Potential benefit: If successful, OssiMend could offer a synthetic bone graft option that helps achieve spinal fusion without the need for autograft and its donor-site morbidity.

How similar studies have performed: Other bone graft substitutes and bioactive graft materials have demonstrated fusion in some studies, but results vary by product and long-term, product-specific data remain limited.

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

Where this trial is running

Encinitas, California and 3 other locations

• San Diego Neurosurgery — Encinitas, California, United States (NOT_YET_RECRUITING)
• Hartford Hospital — Hartford, Connecticut, United States (RECRUITING)
• University Orthopaedic Associates, Division of OrthoNJ — Somerset, New Jersey, United States (NOT_YET_RECRUITING)
• McKenzie-willamette Medical Center — Eugene, Oregon, United States (COMPLETED)

Study contacts

• Study coordinator: Meenakshi Paliwal

Conditions: Spinal Disease, Degenerative Disc Disease, Bone Graft, Lumbar Fusion