Karma Ambispective Study

Spinal Elements

Status: Invitation-only

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

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT07207187

TSN-2025-SEK

Details and patient eligibility

About

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.

Full 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)

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Subjects treated with the Karma Fixation System as part of their spine surgery.

Description:

Subjects implanted with the Karma Fixation System in the lumbar spine as part of their spine surgery.