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Completed

NCT Number: NCT04416321

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

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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Retrolisthesis Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurosurgical Associates of Lancaster

Lancaster, Pennsylvania, 17601, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Interbody fusion rate

    Time frame: 6 months post - operatively

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

Secondary outcomes

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

    Time frame: 6 weeks, 3, 6, 12 and 24 months post operatively

    Visual analogue scale for back and leg 0-10 cm (no pain - worst possible pain)

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

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

    Questionnaire SF-12 collection of questions health related to assess vitality, physical functioning, bodily pain, general health perceptions, emotional and physical functioning, social and mental health. Patients will pick from a set list of answers for each health related question. The responses on each item are scored and summarised into Physical and Mental Health Composite Scores (PCS & MCS) and range from 0-100. The lower the score the more disability. The higher the score the less disability i.e.a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  3. Functional Impairment

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

    Questionnaire ODI (Oswestry Disability Index) - disability questionnaire used to assess functional impairment of the patient. Regarding lifting, ability to walk, sit, stand, sleep, travel and graded by score of 0-100 (0= no disability and 100= maximum disability possible)

Sponsors and collaborators

Lead sponsor

Invibio Ltd

Industry

Collaborators

  • Keos LLC
  • Medical Metrics Diagnostics, Inc
  • Technomics Research
  • Viedoc Technologies

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2020
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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