Status:
ACTIVE_NOT_RECRUITING
A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.
Lead Sponsor:
Invibio Ltd
Collaborating Sponsors:
Keos LLC
Medical Metrics Diagnostics, Inc
Conditions:
Degenerative Disc Disease
Spondylolisthesis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
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 fro...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04416321
Start Date
July 1 2021
End Date
January 1 2026
Last Update
November 21 2025
Active Locations (1)
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1
Neurosurgical Associates of Lancaster
Lancaster, Pennsylvania, United States, 17601