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

COMPLETEDNA

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

A Prospective, Non-comparative, Single-centre, Post-market Clinical Study to Evaluate the Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages for the Treatment of Degenerative Disc Disease in the Lumbar Spine

NCT04416321•Invibio Ltd

View on ClinicalTrials.gov

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 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Locations (1)

Neurosurgical Associates of Lancaster

Lancaster, Pennsylvania, United States

Key Dates

Start Date

July 1, 2021

Primary Completion Date

January 27, 2026

Completion Date

January 27, 2026

Last Updated

January 29, 2026

Enrollment

ACTUAL participants

Conditions

Degenerative Disc DiseaseSpondylolisthesisRetrolisthesis

Interventions

Surgery with the Keos Lumbar Interbody Fusion Device

DEVICE

A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease

NCT07254806

Degenerative Disc Disease

View study

RECRUITINGNA

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

NCT05508360

Degenerative Disc DiseaseChronic Low-back Pain

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

Real World Data Collection on the Synergy Disc