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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 3, 6, 12 and 24 months post operatively
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks, 3, 6, 12 and 24 months post operatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 3, 6, 12 and 24 months post operatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Interbody fusion rate
Secondary outcome measures
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
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
9 Previous Clinical Trials
198 Total Patients Enrolled
1 Trials studying Spondylolisthesis
22 Patients Enrolled for Spondylolisthesis
Keos LLCUNKNOWN
Medical Metrics Diagnostics, IncIndustry Sponsor
12 Previous Clinical Trials
1,675 Total Patients Enrolled
2 Trials studying Spondylolisthesis
337 Patients Enrolled for Spondylolisthesis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have rheumatoid arthritis, ankylosing spondylitis, or a weakened immune system.I have been diagnosed with cancer.I currently have an infection.I have not had spinal surgery at the affected disc level.I have back pain caused by a disc problem.I have been diagnosed with osteoporosis or severe osteopenia.I am taking medication that could affect my bone health.I am 18 years old or older.I am of childbearing age and have a negative pregnancy test.I have completed 6 months of non-surgical treatment.I understand the study and can follow its procedures.I am not pregnant or breastfeeding.I am a candidate for spine surgery to relieve back pain.I am recommended for spine surgery using the Keos system with my own bone graft.I have been diagnosed with painful disc disease or disc disease with spine misalignment in my lower back.I am currently smoking or quit less than 6 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants has this clinical investigation recruited thus far?
"Affirmative, the clinicaltrials.gov database reflects that this trial is currently accepting patients. It was initially posted on July 1st 2021 and has been updated most recently on August 4th 2022. The study requires 30 participants situated across a singular location."
Answered by AI
Are there any further openings for participants in this experiment?
"Affirmative. As per the information hosted on clinicaltrials.gov, this medical investigation is currently recruiting patients; it was initially published on July 1st 2021 and recently updated on August 4th 2022. The trial necessitates 30 people to be enrolled from a single site."
Answered by AI
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