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Interbody Fusion Device

Spinal Fusion Surgery with PEEK-OPTIMA™ HA Enhanced for Degenerative Disc Disease

N/A
Recruiting
Led By Louis A Marotti, M.D. PhD
Research Sponsored by Invibio Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have discogenic back pain
Aged 18 years of age or older
Must not have
Known rheumatoid arthritis, ankylosing spondylitis or who are immunocompromised
Evidence of an active infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 3, 6, 12 and 24 months post operatively
Awards & highlights
No Placebo-Only Group

Summary

This trial is collecting data on patients who had spinal surgery using a certain device to see how effective it was.

Who is the study for?
This trial is for adults over 18 with lower back issues like degenerative disc disease, spondylolisthesis, or retrolisthesis needing spinal fusion surgery. Participants must have tried non-surgical treatments for at least 6 months and be able to follow study procedures. Pregnant women, smokers, drug/alcohol abusers, those with certain diseases or bone metabolism-affecting drugs are excluded.
What is being tested?
The Keos Lumbar Interbody Fusion Device is being tested in patients requiring spinal fusion surgery. The study aims to assess the safety and performance of this device by monitoring clinical outcomes through radiographic and CT scans post-surgery.
What are the potential side effects?
While not explicitly listed here, typical side effects from similar surgeries may include pain at the graft site, nerve damage, blood clots, infection risk at the surgical site or spine area following the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have back pain caused by a disc problem.
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I am 18 years old or older.
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I have completed 6 months of non-surgical treatment.
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I am recommended for spine surgery using the Keos system with my own bone graft.
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I have been diagnosed with painful disc disease or disc disease with spine misalignment in my lower back.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have rheumatoid arthritis, ankylosing spondylitis, or a weakened immune system.
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I currently have an infection.
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I have not had spinal surgery at the affected disc level.
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I have been diagnosed with osteoporosis or severe osteopenia.
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I am not pregnant or breastfeeding.
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I am currently smoking or quit less than 6 months ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 3, 6, 12 and 24 months post operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 3, 6, 12 and 24 months post operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Interbody fusion rate
Secondary study objectives
Functional Impairment
To measure how much pain the subject is in according to a pain scale 0-10
To measure the Quality of Life of the subject according to a set list of questions: Questionnaire SF-12

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DeviceExperimental Treatment1 Intervention
All subjects who are entered into this trial will receive the Keos Lumbar Interbody Fusion Device.

Find a Location

Who is running the clinical trial?

Invibio LtdLead Sponsor
10 Previous Clinical Trials
348 Total Patients Enrolled
1 Trials studying Spondylolisthesis
22 Patients Enrolled for Spondylolisthesis
Keos LLCUNKNOWN
Medical Metrics Diagnostics, IncIndustry Sponsor
13 Previous Clinical Trials
1,734 Total Patients Enrolled
3 Trials studying Spondylolisthesis
421 Patients Enrolled for Spondylolisthesis

Media Library

Keos Lumbar Interbody Fusion Device (Interbody Fusion Device) Clinical Trial Eligibility Overview. Trial Name: NCT04416321 — N/A
Spondylolisthesis Research Study Groups: Device
Spondylolisthesis Clinical Trial 2023: Keos Lumbar Interbody Fusion Device Highlights & Side Effects. Trial Name: NCT04416321 — N/A
Keos Lumbar Interbody Fusion Device (Interbody Fusion Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04416321 — N/A
~7 spots leftby Jan 2026
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