Degenerative Disc DiseaseNCT04416321
A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.
A study testing Surgery with the Keos Lumbar Interbody Fusion Device in people with Degenerative Disc Disease and Spondylolisthesis, run by Invibio Ltd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis
- What is being tested?
- Surgery with the Keos Lumbar Interbody Fusion Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 27 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Neurosurgical Associates of Lancaster
Lancaster, Pennsylvania, 17601
About this study
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
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.
Read the 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.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis
- Being tested
- Surgery with the Keos Lumbar Interbody Fusion Device
- Keywords
- Lumbar Degenerative Disc Disease, Spondylolisthesis, retrolisthesis
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with the Keos Lumbar Interbody Fusion DeviceDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Device | Other | All subjects who are entered into this trial will receive the Keos Lumbar Interbody Fusion Device. Receives: Device: Surgery with the Keos Lumbar Interbody Fusion Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interbody fusion rate
Interbody fusion will be graded along the superior and inferior interfaces separately in 25% increments
Measured: 6 months post - operatively
Secondary outcomes (3)
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)
Measured: 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
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.
Measured: pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively
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)
Measured: pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jul 2021
- Primary completion27 Jan 2026
- Study completion27 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects recruited and will receive the Keos Lumbar Interbody Fusion Device
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invibio Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Keos LLC, Medical Metrics Diagnostics, Inc, Technomics Research, Viedoc Technologies
- Responsible party
- Sponsor
- Investigators
- Louis A Marotti, M.D. PhD, Principal investigator, Neurosurgical Associates of Lancaster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416321
- Sponsor's protocol ID
- KEOS01
- Status last verified
- Apr 2025
- First submitted
- 2 Jun 2020
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04416321
- Acronym / sponsor ID
- KEOS01
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis
- Keywords
- Lumbar Degenerative Disc Disease, Spondylolisthesis, retrolisthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Invibio LtdIndustry (pharma, biotech, devices)
- Collaborators
- Keos LLC, Medical Metrics Diagnostics, Inc, Technomics Research, Viedoc Technologies
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 27 Jan 2026 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects recruited and will receive the Keos Lumbar Interbody Fusion Device
| Arm | Type | Receives |
|---|---|---|
| Device | Other | Device: Surgery with the Keos Lumbar Interbody Fusion DeviceAll subjects who are entered into this trial will receive the Keos Lumbar Interbody Fusion Device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery with the Keos Lumbar Interbody Fusion DeviceAll 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 | Device |
Primary outcome
Interbody fusion rate
Time frame: 6 months post - operatively
Interbody fusion will be graded along the superior and inferior interfaces separately in 25% increments
3 secondary outcomes
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
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
Functional Impairment
Time frame: pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Degenerative Disc Disease
Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis A Marotti, M.D. PhD principal investigator
Neurosurgical Associates of Lancaster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery with the Keos Lumbar Interbody Fusion Device in people with Degenerative Disc Disease and Spondylolisthesis, run by Invibio Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interbody fusion rate (time frame: 6 months post - operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.