A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.
Primary Purpose
Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgery with the Keos Lumbar Interbody Fusion Device
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Lumbar Degenerative Disc Disease, Spondylolisthesis, retrolisthesis
Eligibility Criteria
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.
Sites / Locations
- Neurosurgical Associates of LancasterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Device
Arm Description
All subjects who are entered into this trial will receive the Keos Lumbar Interbody Fusion Device.
Outcomes
Primary Outcome Measures
Interbody fusion rate
Interbody fusion will be graded along the superior and inferior interfaces separately in 25% increments
Secondary Outcome Measures
To measure how much pain the subject is in according to a pain scale 0-10
Visual analogue scale for back and leg 0-10 cm (no pain - worst possible pain)
To measure the Quality of Life of the subject according to a set list of questions: Questionnaire SF-12
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.
Functional Impairment
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)
Full Information
NCT ID
NCT04416321
First Posted
June 2, 2020
Last Updated
September 26, 2023
Sponsor
Invibio Ltd
Collaborators
Keos LLC, Medical Metrics Diagnostics, Inc, Technomics Research, Viedoc Technologies
1. Study Identification
Unique Protocol Identification Number
NCT04416321
Brief Title
A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Invibio Ltd
Collaborators
Keos LLC, Medical Metrics Diagnostics, Inc, Technomics Research, Viedoc Technologies
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis
Keywords
Lumbar Degenerative Disc Disease, Spondylolisthesis, retrolisthesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects recruited and will receive the Keos Lumbar Interbody Fusion Device
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Device
Arm Type
Other
Arm Description
All subjects who are entered into this trial will receive the Keos Lumbar Interbody Fusion Device.
Intervention Type
Device
Intervention Name(s)
Surgery with the Keos Lumbar Interbody Fusion Device
Intervention Description
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 Measure Information:
Title
Interbody fusion rate
Description
Interbody fusion will be graded along the superior and inferior interfaces separately in 25% increments
Time Frame
6 months post - operatively
Secondary Outcome Measure Information:
Title
To measure how much pain the subject is in according to a pain scale 0-10
Description
Visual analogue scale for back and leg 0-10 cm (no pain - worst possible pain)
Time Frame
6 weeks, 3, 6, 12 and 24 months post operatively
Title
To measure the Quality of Life of the subject according to a set list of questions: Questionnaire SF-12
Description
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.
Time Frame
pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively
Title
Functional Impairment
Description
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)
Time Frame
pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Robson
Phone
+44 7765 220492
Email
karen.robson@invibio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sheryl O'Farrell
Phone
+44 7880024484
Email
sheryl.ofarrell@invibio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis A Marotti, M.D. PhD
Organizational Affiliation
Neurosurgical Associates of Lancaster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurosurgical Associates of Lancaster
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nichole Beaty
Phone
717-358-0800
Ext
215
Email
nbeaty@argiresmarotti.com
12. IPD Sharing Statement
Plan to Share IPD
No
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A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.
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