Subjects Treated With Karma Fixation System as Part of Their Spine SurgeryNCT07207187
Karma Ambispective Study
An observational study of Subjects Treated With Karma Fixation System as Part of Their Spine Surgery, run by Spinal Elements at 4 sites in United States.
Trial summary
The purpose of this observational, multi-center, ambispective study is collect real world patient outcomes that characterize the effectiveness of the Karma Fixation System in the lumbar spine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subjects Treated With Karma Fixation System as Part of Their Spine Surgery
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Mar 2025to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Study will include a maximum of 10 US sites.
Who may be able to join
- Skeletally mature and age ≥ 18 years of age at the time of surgery
- Previously treated with the Karma Fixation System
- Has at least 12-months post-surgery imaging obtained including a minimum 2 view x-rays (lateral flexion and lateral extension) and CT scan, or willing to return to obtain imaging
- Be willing and able to comply with the study protocol requirements
- Be willing to sign the study-specific Informed Consent Document
Who cannot join
- Previous fusion or total disc replacement at the index level(s)
- Active systemic infection at the index level at the time of surgery
- Current active or suspected malignancy, or a cancer diagnosis that was ongoing during the patient's treatment and healing period
- Diagnosis of osteomalacia or Paget's bone disease
- Currently enrolled in a competing research study
- Currently incarcerated \
- Currently pregnant or plans to become pregnant
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Sonoran Spine
Gilbert, Arizona, 85297
Ascension St. Vincent's
Jacksonville, Florida, 32259
Neuroscience Specialist
Oklahoma City, Oklahoma, 73134
The Spine Institute of Louisiana
Shreveport, Louisiana, 71101
About this study
Official title: An Ambispective Efficacy Evaluation of the Karma Fixation System
The purpose of this observational, multi-center, ambispective study is collect real world patient outcomes that characterize the effectiveness of the Karma Fixation System in the lumbar spine.
Read the detailed description
This is a multicenter, observational, ambispective study of up to 100 patients across a maximum of 10 US sites. Retrospective data collection will be performed from preoperative up to the single prospective visit. Prospective data collection will include a one-time visit to obtain post-operative imaging. In the event a subject has a complete 12-month data set available retrospectively, the prospective visit may not be required.
PRIMARY ENDPOINTS:
- Fusion status at a minimum of 12-months postoperative (≥10 months post surgery)
SECONDARY ENDPOINTS:
- Procedure-or device-related serious adverse events (SAE)
- Patient reported outcomes if available included, Oswestry Disability Index (ODI), Back and leg pain as measured by Visual Analog Scale (VAS), 12-Item Short Form Health Survey (SF-12)
- Keywords
- Degenerative spine, Karma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects treated with the Karma Fixation System as part of their spine surgery. | Subjects implanted with the Karma Fixation System in the lumbar spine as part of their spine surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion
Fusion at treated levels as measured by x-rays and CT scan.
Measured: 12 month post surgery (≥10 months post surgery)
Secondary outcomes (4)
Serious Adverse Events
Incidence of serious adverse events (SAE).
Measured: Surgery through study completion
Change in Pain
Pain improvement as measured by Visual Analog Scale (VAS), 0-100mm. Higher score indicates increased pain.
Measured: Baseline and 12 months post surgery
Change in Disability
Disability improvement as measured by Oswestry Disability Index (ODI), 0-100%. High score indicates increase disability
Measured: Baseline and 12 months post surgery
Change in Quality of Life
Improvement in qualify of life as measured by 12-item Short Form Health Survey (SF-12), 0-100. High score indicates increase quality of life.
Measured: Baseline and 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start6 Mar 2025
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects Treated With Karma Fixation System as Part of Their Spine SurgeryStudies 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
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spinal Elements
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Spine Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207187
- Sponsor's protocol ID
- TSN-2025-SEK
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ambispective Efficacy Evaluation of the Karma Fixation System
- ClinicalTrials.gov ID
- NCT07207187
- Acronym / sponsor ID
- TSN-2025-SEK
- Keywords
- Degenerative spine, Karma
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Spinal ElementsIndustry (pharma, biotech, devices)
- Collaborators
- The Spine Network
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 3 Oct 2025 (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 observational, multi-center, ambispective study is collect real world patient outcomes that characterize the effectiveness of the Karma Fixation System in the lumbar spine.
Detailed description
This is a multicenter, observational, ambispective study of up to 100 patients across a maximum of 10 US sites. Retrospective data collection will be performed from preoperative up to the single prospective visit. Prospective data collection will include a one-time visit to obtain post-operative imaging. In the event a subject has a complete 12-month data set available retrospectively, the prospective visit may not be required.
PRIMARY ENDPOINTS:
- Fusion status at a minimum of 12-months postoperative (≥10 months post surgery)
SECONDARY ENDPOINTS:
- Procedure-or device-related serious adverse events (SAE)
- Patient reported outcomes if available included, Oswestry Disability Index (ODI), Back and leg pain as measured by Visual Analog Scale (VAS), 12-Item Short Form Health Survey (SF-12)
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects treated with the Karma Fixation System as part of their spine surgery. | – | –Subjects implanted with the Karma Fixation System in the lumbar spine as part of their spine surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study will include a maximum of 10 US sites.
Key inclusion criteria (5 listed)
- Skeletally mature and age ≥ 18 years of age at the time of surgery
- Previously treated with the Karma Fixation System
- Has at least 12-months post-surgery imaging obtained including a minimum 2 view x-rays (lateral flexion and lateral extension) and CT scan, or willing to return to obtain imaging
- Be willing and able to comply with the study protocol requirements
- Be willing to sign the study-specific Informed Consent Document
Key exclusion criteria (7 listed)
- Previous fusion or total disc replacement at the index level(s)
- Active systemic infection at the index level at the time of surgery
- Current active or suspected malignancy, or a cancer diagnosis that was ongoing during the patient's treatment and healing period
- Diagnosis of osteomalacia or Paget's bone disease
- Currently enrolled in a competing research study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fusion
Time frame: 12 month post surgery (≥10 months post surgery)
Fusion at treated levels as measured by x-rays and CT scan.
4 secondary outcomes
Serious Adverse Events
Time frame: Surgery through study completion
Change in Pain
Time frame: Baseline and 12 months post surgery
Change in Disability
Time frame: Baseline and 12 months post surgery
Change in Quality of Life
Time frame: Baseline and 12 months post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subjects Treated With Karma Fixation System as Part of Their Spine Surgery, run by Spinal Elements at 4 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 5 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
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 (time frame: 12 month post surgery (≥10 months post surgery)). 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 3 Oct 2025.