A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.

Study Purpose

The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Aged 18 years of age or older. 2. Primary diagnosis of symptomatic degenerative disc disease (DDD) or symptomatic degenerative disc disease (DDD) with spondylolisthesis (Grade 1), or retrolisthesis, at one or two contiguous levels from L2 to S1. 3. Have discogenic back pain. 4. Suitable for transforaminal lumbar interbody fusion (TLIF) surgery. 5. Indicated for surgical treatment with the Keos Lumbar IBFD with autologous bone graft. 6. Completed at least 6 months of conservative non-operative treatment. 7. Female subjects of childbearing age must have a negative pregnancy test. 8. Able to understand this clinical study, co-operate with procedures. 9. Able to give voluntary, written informed consent to participate.

Exclusion Criteria:

1. Not undergone previous spinal surgery at the affected disc level(s). 2. Evidence of tumour and/or malignant disease. 3. Known osteoporosis or severe osteopenia. 4. Known rheumatoid arthritis, ankylosing spondylitis or who are immunocompromised. 5. Known allergy to the material used in the instrumentation. 6. Evidence of an active infection. 7. Any conditions outlined as contraindicated in the Instructions for Use. 8. Receiving any drug treatment that may affect bone metabolism. 9. Female subjects who are pregnant or lactating. 10. Current smokers or have stopped smoking less than 6 months ago. 11. Known drug or alcohol abusers. 12. Currently enrolled in a clinical study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04416321
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Invibio Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Louis A Marotti, M.D. PhD
Principal Investigator Affiliation Neurosurgical Associates of Lancaster
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryOtherIndustryIndustryOther
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis
Additional Details

This prospective, non-comparative, single-center, post-market trial will evaluate the safety and efficacy of the PEEK-OPTIMA ™ HA Enhanced Keos Lumbar Interbody Fusion Device in patients suffering from degenerative disc disease, spondylolisthesis and retrolisthesis in the lumbar spine. The trial will capture clinical outcomes, radiographic and CT outcomes over a 24 month period post operatively. One centre will be involved in the recruitment of 30 patients the clinic involved will focus on this type of treatment.

Arms & Interventions

Arms

Other: Device

All subjects who are entered into this trial will receive the Keos Lumbar Interbody Fusion Device.

Interventions

Device: - Surgery with the Keos Lumbar Interbody Fusion Device

All subjects will received the Keos Lumbar Interbody Fusion Device if according to the investigators opinion they are clinically indicated to have surgery treatment for degenerative disc disease, spondylolisthesis and retrolisthesis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Neurosurgical Associates of Lancaster, Lancaster, Pennsylvania

Status

Address

Neurosurgical Associates of Lancaster

Lancaster, Pennsylvania, 17601

Site Contact

Nichole Beaty

[email protected]

717-358-0800 #215