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

Launched by INVIBIO LTD · Jun 2, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a new spinal device called the Keos Lumbar Interbody Fusion Device, which is used to help patients with certain back problems like degenerative disc disease and related conditions. The goal is to see how well this device works in patients who have ongoing back pain and have already tried other treatments for at least six months without improvement. The trial is open to adults aged 18 and older who are suitable candidates for a specific type of spinal surgery.

If you join this trial, you’ll undergo a surgery that involves placing the Keos device into your spine, and doctors will track your recovery through various tests, including imaging scans. It's important to know that certain conditions may exclude you from participating, such as having had previous back surgery at the same level or specific health issues like active infections or severe bone diseases. Overall, this study aims to gather valuable information that could help improve treatment options for people with similar back conditions in the future.

Gender

ALL

Eligibility 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.