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

Completed · Not applicable

Conditions studied: Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis

In brief

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.

Key facts

Study ID

NCT04416321

Run by

Invibio Ltd

People needed

25

Starts

2021-07-01

Expected to finish

2026-01-27

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 years of age or older.
• 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.
• Have discogenic back pain.
• Suitable for transforaminal lumbar interbody fusion (TLIF) surgery.
• Indicated for surgical treatment with the Keos Lumbar IBFD with autologous bone graft.
• Completed at least 6 months of conservative non-operative treatment.
• Female subjects of childbearing age must have a negative pregnancy test.
• Able to understand this clinical study, co-operate with procedures.
• Able to give voluntary, written informed consent to participate.

You may not qualify if…

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

Where it is running

• Neurosurgical Associates of Lancaster — Lancaster, Pennsylvania, United States

Full record on ClinicalTrials.gov

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