Clinical trial NCT04775537: OssiMend BA in Posterolateral Instrumented Lumbar Fusion
Official title: OssiMend Bioactive Moldable in Posterolateral Instrumented Lumbar Fusion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Disease
Degenerative Disc Disease
Keywords: Bone Graft
Lumbar Fusion
Lead sponsor: Collagen Matrix
Sponsor class: INDUSTRY
First posted: 2021-03-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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

Detailed description: 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. The primary endpoints are radiographic evidence of fusion and the absence of serious adverse events attributable to OssiMend Bioactive Moldable. The secondary objective is to evaluate the clinical outcomes over a period of 1 year (2 years, if possible).

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

Primary outcomes:
measure: Fusion Success
timeFrame: 12 months
Secondary outcomes:
measure: Visual analog scale (VAS) of back and leg (left and right)
timeFrame: 12 months
measure: Oswestry Lower Back Pain Questionnaire
timeFrame: 12 months
measure: SF36
timeFrame: 12 months
Other outcomes:
Locations:
city: Eugene
country: United States
facility: McKenzie-willamette Medical Center
state: Oregon
Study officials:
References: