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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04416321
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : July 22, 2021
Sponsor:
Collaborators:
Keos LLC
Medical Metrics Diagnostics, Inc
Technomics Research
Viedoc Technologies
Information provided by (Responsible Party):
Invibio Ltd

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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Spondylolisthesis Retrolisthesis Device: Surgery with the Keos Lumbar Interbody Fusion Device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects recruited and will receive the Keos Lumbar Interbody Fusion Device
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Device
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
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 Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  11. Known drug or alcohol abusers.
  12. Currently enrolled in a clinical study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04416321


Contacts
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Contact: Karen Robson +44 7765 220492 karen.robson@invibio.com
Contact: Sheryl O'Farrell +44 7880024484 sheryl.ofarrell@invibio.com

Locations
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United States, Pennsylvania
Neurosurgical Associates of Lancaster Recruiting
Lancaster, Pennsylvania, United States, 17601
Contact: Nichole Beaty    717-358-0800 ext 215    nbeaty@argiresmarotti.com   
Sponsors and Collaborators
Invibio Ltd
Keos LLC
Medical Metrics Diagnostics, Inc
Technomics Research
Viedoc Technologies
Investigators
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Principal Investigator: Louis A Marotti, M.D. PhD Neurosurgical Associates of Lancaster
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Responsible Party: Invibio Ltd
ClinicalTrials.gov Identifier: NCT04416321    
Other Study ID Numbers: KEOS01
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Invibio Ltd:
Lumbar Degenerative Disc Disease
Spondylolisthesis
retrolisthesis
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis