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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Degenerative Disc Disease
Intervention / Treatment

-

Contacts and Locations

Lancaster

Neurosurgical Associates of Lancaster, Lancaster, Pennsylvania, United States, 17601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Invibio Ltd,

Louis A Marotti, M.D. PhD, PRINCIPAL_INVESTIGATOR, Neurosurgical Associates of Lancaster

Study Record Dates

2026-01