Spinal Elements
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 adv…
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…
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