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

NCT04416321 | Completed FDA Device

• 1 other identifier: KEOS01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Disc Disease; Spondylolisthesis; Retrolisthesis

Keywords

Lumbar Degenerative Disc Disease; Spondylolisthesis; retrolisthesis

Outcome Measures

Primary Outcomes (1)

• Interbody fusion rate

  Interbody fusion will be graded along the superior and inferior interfaces separately in 25% increments

  6 months post - operatively

Secondary Outcomes (3)

• To measure how much pain the subject is in according to a pain scale 0-10

  6 weeks, 3, 6, 12 and 24 months post operatively

• To measure the Quality of Life of the subject according to a set list of questions: Questionnaire SF-12

  pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively

• Functional Impairment

  pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively

Study Arms (1)

Device

OTHER

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

Device: Surgery with the Keos Lumbar Interbody Fusion Device

Interventions

Surgery with the Keos Lumbar Interbody Fusion Device 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

Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Invibio Ltd: lead
• Keos LLC: collaborator
• Viedoc Technologies: collaborator
• Medical Metrics Diagnostics, Inc: collaborator
• Technomics Research: collaborator

Study Sites (1)

Neurosurgical Associates of Lancaster

Lancaster, Pennsylvania, 17601, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Officials

• Louis A Marotti, M.D. PhD

  Neurosurgical Associates of Lancaster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects recruited and will receive the Keos Lumbar Interbody Fusion Device

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: July 1, 2021
• Primary Completion: January 27, 2026
• Study Completion: January 27, 2026
• Last Updated: January 29, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)