NCT07207187
Karma Ambispective Study
Enrolling by Invitation
Not specifiedAges 18+ObservationalSpinal Elements
~100 participants
Updated 2025-10-03 on ClinicalTrials.gov
At a glance
Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fusion
Measured over 12 month post surgery (≥10 months post surgery)
Conditions
Where it's being run
4 sites across 4 statesArizona1
Florida1
Louisiana1
Oklahoma1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
Exclusion
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
What this trial measures
- Fusion12 month post surgery (≥10 months post surgery)
Fusion at treated levels as measured by x-rays and CT scan.