NCT07207187

Karma Ambispective Study

An Ambispective Efficacy Evaluation of the Karma Fixation System

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Spinal Elements · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

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

Timeline

• Start date: 2025-03-06
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-10-03
• Last updated: 2025-10-03

Locations

4 sites across 1 country: United States