OssiMend BA in Posterolateral Instrumented Lumbar Fusion

• Conditions: Spinal Disease; Degenerative Disc Disease
• Interventions: Device: OssiMend™ Bioactive Moldable

• Registration Number: NCT04775537
• Lead Sponsor: Collagen Matrix

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).

Study Timeline

• Study Start: 2021-01-21
• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-22
• Primary Completion: 2022-12-21
• Study Completion: 2023-08-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OssiMend™ Bioactive Moldable	OssiMend™ Bioactive Moldable	Patients undergoing Lumber Spine Fusion

Primary Outcome Measures

Name	Time	Method
Fusion Success	12 months	Fusion will be assessed with A/P and Lateral radiographs taken and scored with Lenke's classification of posterolateral fusion success

Secondary Outcome Measures

Name	Time	Method
Oswestry Lower Back Pain Questionnaire	12 months	Pain/Disability as measured by Oswestry Lower Back Pain Questionnaire
SF36	12 months	Pain and function as measured by the Short - Form 36
Visual analog scale (VAS) of back and leg (left and right)	12 months	Improvement of pain as defined by the Visual analog scale (VAS) of back and leg (left and right)

Trial Locations

Locations (1)

McKenzie-willamette Medical Center; 🇺🇸 Eugene, Oregon, United States