Status:
ENROLLING_BY_INVITATION
Karma Ambispective Study
Lead Sponsor:
Spinal Elements
Collaborating Sponsors:
The Spine Network
Conditions:
Subjects Treated With Karma Fixation System as Part of Their Spine Surgery
Eligibility:
All Genders
18+ years
Brief 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.
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 prosp...
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
Key Trial Info
Start Date :
March 6 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07207187
Start Date
March 6 2025
End Date
January 1 2026
Last Update
October 3 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Sonoran Spine
Gilbert, Arizona, United States, 85297
2
Ascension St. Vincent's
Jacksonville, Florida, United States, 32259
3
The Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101
4
Neuroscience Specialist
Oklahoma City, Oklahoma, United States, 73134