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Study of the Long-Term Outcomes of Posterior Spinal Fixation With the Karma Device | Clinical Trials | Clareo Health

COMPLETED

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

NCT04984213•Spinal Elements

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (1)

Spine Institute of Louisiana

Shreveport, Louisiana, United States

Key Dates

Start Date

August 15, 2021

Primary Completion Date

June 16, 2025

Completion Date

June 16, 2025

Last Updated

June 29, 2025

Enrollment

ACTUAL participants

Conditions

Lumbar Disc Disease

Interventions

Karma Posterior Fixation Device

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Postoperative Scar in the Control Excess of Mobility Induced by Annulus Removal on Inserting a Lumbar Disc Prosthesis

Advanced XLIF Monitoring Pilot Study

Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease

Effects of Kinesio Taping on Pain, Endurance, Proprioception, Mobility and Disability in Lumbar Disc Herniation

The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.

Injection of Autologous Bone Marrow Aspirate in Patients With Degenerative Disc Disease.