OssiMend BA in Posterolateral Instrumented Lumbar Fusion

Degenerative Disc Disease Clinical Trial

Official title:

OssiMend Bioactive Moldable in Posterolateral Instrumented Lumbar Fusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04775537
• Other study ID #: CIP.072.Spine Prospective
• Status: Recruiting
• Start date: January 21, 2021
• Est. completion date: August 21, 2023

Study information

• Verified date: March 2022
• Source: Collagen Matrix
• Contact: Mohamed Moawad
• Phone: 2014051477
• Email: mmoawad[@]collagenmatrix.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 21, 2023
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Disease
• Spinal Diseases

Intervention

Device:
• OssiMend™ Bioactive Moldable
Lumbar Spine fusion with OssiMend™ Bioactive Moldable

Locations

Country	Name	City	State
United States	McKenzie-willamette Medical Center	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Collagen Matrix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual analog scale (VAS) of back and leg (left and right)	Improvement of pain as defined by the Visual analog scale (VAS) of back and leg (left and right)	12 months
Secondary	Oswestry Lower Back Pain Questionnaire	Pain/Disability as measured by Oswestry Lower Back Pain Questionnaire	12 months
Secondary	SF36	Pain and function as measured by the Short - Form 36	12 months

External Links

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