OssiMend BA for posterolateral instrumented lumbar fusion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hartford Hospital
  Hartford, Connecticut, United States Recruiting
• San Diego Neurosurgery
  Encinitas, California, United States Not yet 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
• Email: mpaliwal@collagenmatrix.com
• Phone: 12014051477

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.