Actively Recruiting

Age: 18Years +
All Genders
NCT04775537

OssiMend BA in Posterolateral Instrumented Lumbar Fusion

Led by Collagen Matrix · Updated on 2025-10-16

120

Participants Needed

4

Research Sites

314 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

OssiMend BA in Posterolateral Instrumented Lumbar Fusion

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be 18 years of age or older at the time of consent
  • Have a documented diagnosis of degenerative disc disease (DDD) that has not improved after at least 6 months of nonoperative treatment
  • Have back and/or radicular pain with disc degeneration confirmed by medical history, physical exam, and imaging studies such as CT, MRI, X-ray, discography, or myelography
  • Show one or more of the following findings: instability (>3mm translation or >5 degrees angulation), osteophyte formation of facet joints or vertebral endplates, decreased disc height (>2mm average depending on spinal level), herniated nucleus pulposus, or facet joint degeneration/changes
Not Eligible

You will not qualify if you...

  • Be under 18 years of age at the time of consent
  • Have had prior lumbar spine fusion surgery at any level
  • Currently be undergoing treatment for malignancy or have a history of cancer treatment
  • Be pregnant, nursing, or planning to become pregnant within 24 months after surgery
  • Have an active infection or be receiving treatment for infection
  • Be involved in workers compensation claims or active litigation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

San Diego Neurosurgery

Encinitas, California, United States, 92024

Not Yet Recruiting

2

Hartford Hospital

Hartford, Connecticut, United States, 06102

Actively Recruiting

3

University Orthopaedic Associates, Division of OrthoNJ

Somerset, New Jersey, United States, 08873

Not Yet Recruiting

4

McKenzie-willamette Medical Center

Eugene, Oregon, United States, 97401

Completed

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Research Team

M

Meenakshi Paliwal

CONTACT

P

Peggy Hansen

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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