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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04775537
Other study ID # CIP.072.Spine Prospective
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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