Karma Ambispective Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-06

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No