Lumbar Disc DiseaseNCT04984213
Study of the Long-Term Outcomes of Posterior Spinal Fixation With the Karma Device
An observational study of Lumbar Disc Disease, run by Spinal Elements at 1 site in United States.
Trial summary
The primary objective of this clinical study is to measure fusion rate in patients at 12 months following lumbar fusion in combination with posterior fixation using the Karma® device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Disease
- What is being tested?
- Karma Posterior Fixation Device
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2021to 16 Jun 2025
- Phase
- Observational
- 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
Study population: Subjects needing a lumbar fusion surgery
Who may be able to join
- Skeletally mature and age ≥ 18 years of age
- Appropriate patient as determined by the Investigator for anterior or lateral approach to lumbar interbody fusion surgery with planned posterior fixation to treat degenerative disc disease in one or two adjacent vertebral levels between L2 and S1.
- Failed at least six months of conservative treatment. This may or may not include any of the following,
- Spinal injections
- Chiropractic care
- Physical therapy
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- Activity modification and/or with anti-inflammatory medications
- Oswestry Low Back Pain Disability Questionnaire score of at least 30%
- Visual Analog Scale (VAS) for back/hip/lower extremity pain ranking at a minimum at least 3/10 (30%)
- Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule, study requirements with a signed informed consent with a study collaborator present at the time of signing to ensure compliance.
Who cannot join
- Patients with greater than two levels of degenerative disease or deformity for INTENDED operative levels.
- Previous fusion or total disc replacement at the intended level/s
- Known allergy to implant and instrument materials
- Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
- Degenerative spondylolisthesis of grade >2
- Isthmic spondylolisthesis
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- Back or leg pain of unknown etiology
- Active systemic infection or infection at the location planned surgery
- Active or suspected malignancy. If symptom free for 2 years, patients with prior malignancy may be included.
- Morbid obesity defined as a body mass index > 40
- Patient being treated for other specific medical conditions that may affect bone density or the ability to obtain fusion (ie: steroids, etc)
- Pregnant or have plans to become pregnant in the next year.
- Currently a prisoner
- Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol
- Participation in a concurrent clinical study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
About this study
Official title: CORTI-FIX: Clinical and Radiographic Outcomes Following Lumbar Interbody Placement With Posterior Minimally Invasive Intra-Laminar PEEK Ratcheting Fixation Device
The primary objective of this clinical study is to measure fusion rate in patients at 12 months following lumbar fusion in combination with posterior fixation using the Karma® device.
- Conditions
- Lumbar Disc Disease
- Being tested
- Karma Posterior Fixation Device
- Medical subject headings
- Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Karma Posterior Fixation DeviceDevice
Posterior Fixation
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion Rate
Interbody Fusion Rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start15 Aug 2021
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spinal Elements
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984213
- Sponsor's protocol ID
- SEI-004
- Status last verified
- Jun 2025
- First submitted
- 20 Jul 2021
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORTI-FIX: Clinical and Radiographic Outcomes Following Lumbar Interbody Placement With Posterior Minimally Invasive Intra-Laminar PEEK Ratcheting Fixation Device
- ClinicalTrials.gov ID
- NCT04984213
- Acronym / sponsor ID
- SEI-004
- Conditions
- Lumbar Disc Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Spinal ElementsIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 30 Jul 2021 (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 primary objective of this clinical study is to measure fusion rate in patients at 12 months following lumbar fusion in combination with posterior fixation using the Karma® device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects needing a lumbar fusion surgery
Key inclusion criteria (10 listed)
- Skeletally mature and age ≥ 18 years of age
- Appropriate patient as determined by the Investigator for anterior or lateral approach to lumbar interbody fusion surgery with planned posterior fixation to treat degenerative disc disease in one or two adjacent vertebral levels between L2 and S1.
- Failed at least six months of conservative treatment. This may or may not include any of the following,
- Oswestry Low Back Pain Disability Questionnaire score of at least 30%
- Visual Analog Scale (VAS) for back/hip/lower extremity pain ranking at a minimum at least 3/10 (30%)
Key exclusion criteria (15 listed)
- Patients with greater than two levels of degenerative disease or deformity for INTENDED operative levels.
- Previous fusion or total disc replacement at the intended level/s
- Known allergy to implant and instrument materials
- Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
- Degenerative spondylolisthesis of grade >2
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 |
|---|---|---|
| Karma Posterior Fixation DevicePosterior Fixation | Device | – |
Primary outcome
Fusion Rate
Time frame: 12 months
Interbody Fusion Rate
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 29 Jun 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Disease, run by Spinal Elements 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 10 inclusion and 15 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 29 Jun 2025. 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?
Fusion Rate (time frame: 12 months). 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 29 Jun 2025.