Subjects Treated With Karma Fixation System as Part of Their Spine Surgery
Conditions
Keywords
Degenerative spine, Karma
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)
Interventions
None listed
Sponsors
The Spine Network
Spinal Elements
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion | 12 month post surgery (≥10 months post surgery) | Fusion at treated levels as measured by x-rays and CT scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Disability | Baseline and 12 months post surgery | Disability improvement as measured by Oswestry Disability Index (ODI), 0-100%. High score indicates increase disability |
| 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. |
Countries
United States
Outcome results
None listed