Karma Ambispective Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Subjects Treated With Karma Fixation System as Part of Their Spine Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Ambispective Efficacy Evaluation of the Karma Fixation System
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.
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)
Primary outcome measures
- Fusion [Time frame: 12 month post surgery (≥10 months post surgery)]
Secondary outcome measures (4)
- Serious Adverse Events [Time frame: Surgery through study completion]
- Change in Pain [Time frame: Baseline and 12 months post surgery]
- Change in Disability [Time frame: Baseline and 12 months post surgery]
- Change in Quality of Life [Time frame: Baseline and 12 months post surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 4 centers
- Sonoran Spine — Gilbert
- Ascension St. Vincent's — Jacksonville
- The Spine Institute of Louisiana — Shreveport
- Neuroscience Specialist — Oklahoma City
Identifiers
NCT: NCT07207187 · TSN-2025-SEK