Karma Ambispective Study

NCT07207187 | Enrolling By Invitation

• 1 other identifier: TSN-2025-SEK
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

Degenerative spine; Karma

Outcome Measures

Primary Outcomes (1)

• Fusion

  Fusion at treated levels as measured by x-rays and CT scan.

  12 month post surgery (≥10 months post surgery)

Secondary Outcomes (4)

• Serious Adverse Events

  Surgery through study completion

• Change in Pain

  Baseline and 12 months post surgery

• Change in Disability

  Baseline and 12 months post surgery

• Change in Quality of Life

  Baseline and 12 months post surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study will include a maximum of 10 US sites.

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

Sponsors & Collaborators

• Spinal Elements: lead
• The Spine Network: collaborator

Study Sites (4)

Sonoran Spine

Gilbert, Arizona, 85297, United States

Location

Ascension St. Vincent's

Jacksonville, Florida, 32259, United States

Location

The Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Neuroscience Specialist

Oklahoma City, Oklahoma, 73134, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: March 6, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

US (4)