Karma Ambispective Study
Part of paid clinical trials in Gilbert, Arizona.
- Sponsor
- Spinal Elements
- Study ID
- NCT07207187
- Status
- Enrolling By Invitation
Conditions
- Subjects Treated With Karma Fixation System as Part of Their Spine Surgery
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- Mar 6, 2025
- Status verified
- Sep 2025
- Primary completion
- Jan 31, 2026
- Completion
- Jan 31, 2026
Study Design
- Enrollment
- 100 participants (estimated)
Arms
- Arm: 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.
Primary Outcome Measure
Fusion [ Time Frame: 12 month post surgery (≥10 months post surgery) ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sonoran Spine | Gilbert | Arizona | 85297 | - |
| Ascension St. Vincent's | Jacksonville | Florida | 32259 | - |
| The Spine Institute of Louisiana | Shreveport | Louisiana | 71101 | - |
| Neuroscience Specialist | Oklahoma City | Oklahoma | 73134 | - |