Karma Ambispective Study

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

• Registration Number: NCT07207187
• Lead Sponsor: Spinal Elements

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 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 Timeline

• Study Start: 2025-03-06
• Status Verified: 2025-09
• Study First Submitted: 2025-09-26
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2026-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fusion	12 month post surgery (≥10 months post surgery)	Fusion at treated levels as measured by x-rays and CT scan.

Secondary Outcome Measures

Name	Time	Method
Change in Disability	Baseline and 12 months post surgery	Disability improvement as measured by Oswestry Disability Index (ODI), 0-100%. High score indicates increase disability
Serious Adverse Events	Surgery through study completion	Incidence of serious adverse events (SAE).
Change in Pain	Baseline and 12 months post surgery	Pain improvement as measured by Visual Analog Scale (VAS), 0-100mm. Higher score indicates increased pain.
Change in Quality of Life	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.

Trial Locations

Locations (4)

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