Degenerative Disc Disease LumbarNCT03928041
A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages in the Lumbar Spine
A study testing Device: EVOS Lumbar Interbody System (EVOS-HA) in people with Degenerative Disc Disease Lumbar and Spondylolisthesis, Grade 1, run by Invibio Ltd at 2 sites in United States.
Trial summary
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo interbody spinal fusion using the EVOS Lumbar Interbody System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease Lumbar, Spondylolisthesis, Grade 1
- What is being tested?
- Device: EVOS Lumbar Interbody System (EVOS-HA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jun 2019to 25 Sep 2023
- 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
- Is the subject aged 18 years of age or older and skeletally mature?
- Does the subject have a primary diagnosis of symptomatic degenerative disc disease (DDD) or symptomatic degenerative disc disease (DDD) with spondylolisthesis (Grade 1) at one or two contiguous levels from L2 to S1?
- Does the subject have discogenic back pain with degeneration of the disc confirmed by medical history, radiographic examination and MRI (MRI must be obtained within the 6 months prior to subject surgery and radiographs obtained within 3 months prior to subject surgery)?
- Is the subject judged by the Investigator to be suitable for transforaminal lumbar interbody fusion (TLIF) surgery based on their medical history?
- Is the subject indicated for surgical treatment with the EVOS Lumbar Interbody System with autologous bone graft?
- Has the subject completed at least 6 months of conservative non-operative treatment without obtaining adequate symptomatic relief?
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- If the subject is female and of childbearing age, do they have a negative pregnancy test (by Beta HCG qualitative analysis), or do they have a history of a surgical sterilisation, or a history of no menses in the past twelve months?
- Is the subject, in the opinion of the Investigator, able to understand this clinical study, co-operate with the procedures and are they willing to return to the hospital for all the required post-operative follow-ups?
- Is the subject able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained?
Who cannot join
- Has the subject undergone previous spinal surgery at the affected disc level(s), excluding discectomy and laminectomy procedures?
- Does the subject have evidence of tumour and/or malignant disease with resultant life expectancy of less than two years?
- Does the subject have known osteoporosis or severe osteopenia as determined by the Investigator?
- Does the subject have rheumatoid arthritis, ankylosing spondylitis or are they immunocompromised?
- Does the subject have a known allergy to the material used in the instrumentation?
- Does the subject have evidence of an active infection and/or do they have any condition that would compromise their participation and follow-up in this clinical study?
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- Is the subject receiving any drug treatment that may affect bone metabolism?
- If the subject is female, are they pregnant or lactating?
- Is the subject a current smoker, or have they stopped smoking less than 6 months ago?
- Is the subject a known drug or alcohol abuser or do they have a baseline opioid use greater than 30 mg of morphine equivalent/day or do they have psychological disorders that could affect follow-up care or treatment outcomes?
- Is the subject currently enrolled in a clinical study?
Trial locations and contacts
2 sites in 1 country.
United States2 sites
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Prospective, Non-comparative, Multi-center, Post-market Clinical Study to Evaluate the Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages for the Treatment of Degenerative Disc Disease and Spondylolisthesis in the Lumbar Spine
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo interbody spinal fusion using the EVOS Lumbar Interbody System.
Read the detailed description
This prospective, non-comparative, multi-center, post-market trial will evaluate the safety and efficacy of the PEEK-OPTIMA™ HA Enhance Interbody Cages System - EVOS- HA in patients suffering from degenerative disc disease and spondylolisthesis in the lumbar spine. The trial will capture clinical outcomes, radiographic and CT outcomes over a 24 month period post operatively. Two centers will be involved in the recruitment of 30 patients. All patients will be drawn from clinics which focus on this type of treatment.
- Being tested
- Device: EVOS Lumbar Interbody System (EVOS-HA)
- Keywords
- Lumbar Degenerative Disc Disease, Spondylolisthesis
- Medical subject headings
- Spondylolisthesis, Lymphoma, Follicular, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: EVOS Lumbar Interbody System (EVOS-HA)Device
All subjects will receive the EVOS Lumbar Interbody System (EVOS-HA) device if according to the investigators opinion they are clinically indicated to have surgery treatment for degenerative disc disease and spondylolisthesis.
| Study group | Role | What they receive |
|---|---|---|
| single prospective study | Other | All subjects who are entered into this trial will receive the EVOS Lumbar Interbody System (EVOS- HA). Receives: Device: Device: EVOS Lumbar Interbody System (EVOS-HA) |
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 in accordance with Cook et al. 2004 where bridging bone is 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 summarized into Physical and Mental Health Composite Scores (PCS \& MCS) and range from 0 to 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 uses to assess functional impairment of the patient. Regarding lifting, ability to walk, sit, stand sleep, travel 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 posted25 Apr 2019
- Study start27 Jun 2019
- Primary completion22 May 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc Disease LumbarStudies 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
- Sequential
- Model description
- All subjects will be recruited and receive the EVOS-HA prospectively.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invibio Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical Metrics Diagnostics, Inc
- Responsible party
- Sponsor
- Investigators
- Mark A Kurd, M.D., Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928041
- Sponsor's protocol ID
- CES01
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2019
- Last updated
- 10 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-comparative, Multi-center, Post-market Clinical Study to Evaluate the Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages for the Treatment of Degenerative Disc Disease and Spondylolisthesis in the Lumbar Spine
- ClinicalTrials.gov ID
- NCT03928041
- Acronym / sponsor ID
- CES01
- Keywords
- Lumbar Degenerative Disc Disease, Spondylolisthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Invibio LtdIndustry (pharma, biotech, devices)
- Collaborators
- Medical Metrics Diagnostics, Inc
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 25 Apr 2019 (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 interbody spinal fusion using the EVOS Lumbar Interbody System.
Detailed description
This prospective, non-comparative, multi-center, post-market trial will evaluate the safety and efficacy of the PEEK-OPTIMA™ HA Enhance Interbody Cages System - EVOS- HA in patients suffering from degenerative disc disease and spondylolisthesis in the lumbar spine. The trial will capture clinical outcomes, radiographic and CT outcomes over a 24 month period post operatively. Two centers will be involved in the recruitment of 30 patients. All patients will be drawn from clinics which focus on this type of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will be recruited and receive the EVOS-HA prospectively.
| Arm | Type | Receives |
|---|---|---|
| single prospective study | Other | Device: Device: EVOS Lumbar Interbody System (EVOS-HA)All subjects who are entered into this trial will receive the EVOS Lumbar Interbody System (EVOS- HA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Is the subject aged 18 years of age or older and skeletally mature?
- Does the subject have a primary diagnosis of symptomatic degenerative disc disease (DDD) or symptomatic degenerative disc disease (DDD) with spondylolisthesis (Grade 1) at one or two contiguous levels from L2 to S1?
- Does the subject have discogenic back pain with degeneration of the disc confirmed by medical history, radiographic examination and MRI (MRI must be obtained within the 6 months prior to subject surgery and radiographs obtained within 3 months prior to subject surgery)?
- Is the subject judged by the Investigator to be suitable for transforaminal lumbar interbody fusion (TLIF) surgery based on their medical history?
- Is the subject indicated for surgical treatment with the EVOS Lumbar Interbody System with autologous bone graft?
Key exclusion criteria (11 listed)
- Has the subject undergone previous spinal surgery at the affected disc level(s), excluding discectomy and laminectomy procedures?
- Does the subject have evidence of tumour and/or malignant disease with resultant life expectancy of less than two years?
- Does the subject have known osteoporosis or severe osteopenia as determined by the Investigator?
- Does the subject have rheumatoid arthritis, ankylosing spondylitis or are they immunocompromised?
- Does the subject have a 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 |
|---|---|---|
| Device: EVOS Lumbar Interbody System (EVOS-HA)All subjects will receive the EVOS Lumbar Interbody System (EVOS-HA) device if according to the investigators opinion they are clinically indicated to have surgery treatment for degenerative disc disease and spondylolisthesis. | Device | single prospective study |
Primary outcome
Interbody fusion rate
Time frame: 6 months post - operatively
Interbody fusion will be graded in accordance with Cook et al. 2004 where bridging bone is 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 10 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Mark A Kurd, M.D. principal investigator
Thomas Jefferson University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: EVOS Lumbar Interbody System (EVOS-HA) in people with Degenerative Disc Disease Lumbar and Spondylolisthesis, Grade 1, run by Invibio Ltd at 2 sites 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 11 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 10 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 2 sites 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 10 Sep 2026.