Karma Ambispective Study

Enrolling by invitation

Conditions studied: Subjects Treated With Karma Fixation System as Part of Their Spine Surgery

In brief

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 facts

Study ID

NCT07207187

Run by

Spinal Elements

People needed

100

Starts

2025-03-06

Expected to finish

2026-01-01

Last updated by the study team

2025-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sonoran Spine — Gilbert, Arizona, United States
• Ascension St. Vincent's — Jacksonville, Florida, United States
• The Spine Institute of Louisiana — Shreveport, Louisiana, United States
• Neuroscience Specialist — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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