Prospective, Observational Registry of Renaissance-guided Spine Surgeries

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

TERMINATED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-18

Study Completion Date

2016-12-30

Brief Summary

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To establish an observational registry for systematic collection of clinical data from Renaissance-guided spine surgeries.

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Detailed Description

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The key objective of this observational registry is to prospectively collect data to facilitate the quantification of potential short- and long-term benefits of Renaissance-guided spine surgery. It establishes a common framework for collaboration between surgeons performing Renaissance-guided spine surgeries in either minimally invasive (MIS) or open surgical approaches.

The main endpoints that will be collected are surgical endpoints (e.g. complication rates), patient reported outcomes (e.g. VAS, ODI), imaging parameters (e.g. coronal and sagittal alignment, mainly in reconstructive surgeries for spinal deformities) and technical parameters (e.g. use of intraoperative fluoroscopy, ratio of planned vs. executed screws).

Conditions

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Degenerative Spine Disease Spinal Deformity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Patients undergoing spinal surgery in a posterior approach where the surgeon used Renaissance surgical guidance system.

Patient capable of complying with study requirements. Signed informed consent by patient.

Exclusion Criteria

Any significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study.

Patient cannot follow study protocol, for any reason. Patient cannot or will not sign informed consent.

Minimum Eligible Age

6 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No