Study of the Long-Term Outcomes of Posterior Spinal Fixation With the Karma Device

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Disc Disease
• Intervention / Treatment: Device: Karma Posterior Fixation Device

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Spine Institute of Louisiana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects needing a lumbar fusion surgery

Description

Inclusion Criteria:

1. Skeletally mature and age ≥ 18 years of age
2. 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.

3. Failed at least six months of conservative treatment. This may or may not include any of the following,

   1. Spinal injections
   2. Chiropractic care
   3. Physical therapy
   4. Activity modification and/or with anti-inflammatory medications
4. Oswestry Low Back Pain Disability Questionnaire score of at least 30%
5. Visual Analog Scale (VAS) for back/hip/lower extremity pain ranking at a minimum at least 3/10 (30%)
6. 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.

Exclusion Criteria:

1. Patients with greater than two levels of degenerative disease or deformity for INTENDED operative levels.
2. Previous fusion or total disc replacement at the intended level/s
3. Known allergy to implant and instrument materials
4. Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
5. Degenerative spondylolisthesis of grade >2
6. Isthmic spondylolisthesis
7. Back or leg pain of unknown etiology
8. Active systemic infection or infection at the location planned surgery
9. Active or suspected malignancy. If symptom free for 2 years, patients with prior malignancy may be included.
10. Morbid obesity defined as a body mass index > 40
11. Patient being treated for other specific medical conditions that may affect bone density or the ability to obtain fusion (ie: steroids, etc)
12. Pregnant or have plans to become pregnant in the next year.
13. Currently a prisoner
14. Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol
15. Participation in a concurrent clinical study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion Rate	Interbody Fusion Rate	12 months

Collaborators and Investigators

• Sponsor: Spinal Elements

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Actual): June 16, 2025
• Study Completion (Actual): June 16, 2025

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SEI-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No