Karma Ambispective Study

September 26, 2025 updated by: Spinal Elements

An Ambispective Efficacy Evaluation of the Karma Fixation System

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.

Study Overview

Status

Enrolling by invitation

Conditions

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 prospective visit. Prospective data collection will include a one-time visit to obtain post-operative imaging. In the event a subject has a complete 12-month data set available retrospectively, the prospective visit may not be required.

PRIMARY ENDPOINTS:

- Fusion status at a minimum of 12-months postoperative (≥10 months post surgery)

SECONDARY ENDPOINTS:

  • Procedure-or device-related serious adverse events (SAE)
  • Patient reported outcomes if available included, Oswestry Disability Index (ODI), Back and leg pain as measured by Visual Analog Scale (VAS), 12-Item Short Form Health Survey (SF-12)

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Sonoran Spine
    • Florida
      • Jacksonville, Florida, United States, 32259
        • Ascension St. Vincent's
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • The Spine Institute of Louisiana
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73134
        • Neuroscience Specialist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study will include a maximum of 10 US sites.

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fusion
Time Frame: 12 month post surgery (≥10 months post surgery)
Fusion at treated levels as measured by x-rays and CT scan.
12 month post surgery (≥10 months post surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Adverse Events
Time Frame: Surgery through study completion
Incidence of serious adverse events (SAE).
Surgery through study completion
Change in Pain
Time Frame: Baseline and 12 months post surgery
Pain improvement as measured by Visual Analog Scale (VAS), 0-100mm. Higher score indicates increased pain.
Baseline and 12 months post surgery
Change in Disability
Time Frame: Baseline and 12 months post surgery
Disability improvement as measured by Oswestry Disability Index (ODI), 0-100%. High score indicates increase disability
Baseline and 12 months post surgery
Change in Quality of Life
Time Frame: Baseline and 12 months post surgery
Improvement in qualify of life as measured by 12-item Short Form Health Survey (SF-12), 0-100. High score indicates increase quality of life.
Baseline and 12 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spinal Elements

Collaborators

The Spine Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

September 26, 2025

First Submitted That Met QC Criteria

September 26, 2025

First Posted (Actual)

October 3, 2025

Study Record Updates

Last Update Posted (Actual)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TSN-2025-SEK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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