Karma Ambispective Study

N/AEnrolling By InvitationNCT07207187

Spinal Elements100 enrolled

Overview

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.

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

100

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Fusion

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

Time frame: 12 month post surgery (≥10 months post surgery)

Secondary Outcomes

Serious Adverse Events

Incidence of serious adverse events (SAE).

Time frame: Surgery through study completion

Change in Pain

Pain improvement as measured by Visual Analog Scale (VAS), 0-100mm. Higher score indicates increased pain.

Time frame: Baseline and 12 months post surgery

Change in Disability

Disability improvement as measured by Oswestry Disability Index (ODI), 0-100%. High score indicates increase disability

Time frame: Baseline and 12 months post surgery

Change in Quality of Life

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.

Time frame: Baseline and 12 months post surgery

Data from ClinicalTrials.gov

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