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OssiMend BA in Posterolateral Instrumented Lumbar Fusion for Spinal Disease

This observational study is looking at how well a device called OssiMend™ Bioactive Moldable works when used in spinal fusion surgery. Spinal fusion is an operation that joins two or more bones in your spine. Researchers want to see if using OssiMend™ Bioactive Moldable as the bone grafting material helps achieve successful fusion. You may be able to join if you are 18 or older and have degenerative disc disease (DDD), a condition where the discs between your spinal bones break down, causing back or leg pain. Your DDD must not have improved with other treatments for at least six months. The study will measure fusion success after 12 months. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 120 participants. It will look at the results of spinal fusion surgery using OssiMend™ Bioactive Moldable.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 12 months to check for fusion success and up to 2 years for clinical outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04775537

OssiMend BA in Posterolateral Instrumented Lumbar Fusion

Recruiting
Not specifiedAges 18+Observational
Collagen Matrix
~120 participants
Updated 2025-10-16 on ClinicalTrials.gov
What's tested:OssiMend™ Bioactive Moldable

At a glance

Recruiting sites
1 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fusion Success
Measured over 12 months

Conditions

Spinal Disease
Degenerative Disc Disease

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NCT04775537

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Hartford Hospital

    Hartford, Connecticutstudy coordinator listed

    Recruiting

  • University Orthopaedic Associates, Division of OrthoNJ

    Somerset, New Jerseystudy coordinator listed

    Not yet recruiting

  • San Diego Neurosurgery

    Encinitas, Californiano site contact published

    Not yet recruiting

  • McKenzie-willamette Medical Center

    Eugene, Oregonno site contact published

    Completed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Meenakshi Paliwal
[email protected]
12014051477
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

What this trial measures

  • Fusion Success12 months

    Fusion will be assessed with A/P and Lateral radiographs taken and scored with Lenke's classification of posterolateral fusion success