CompletedNot Applicable

Comprehensive Spinal Alignment Planning Study

United States306 participantsStarted 2016-03

Plain-language summary

A comprehensive approach to the evaluation of alignment in spinal surgery patients - through preoperative planning, intraoperative assessment, and postoperative confirmation - has not been well-studied. This study aims to assess the value of such planning through clinical and radiographic outcomes.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male and female patients who are at least 18 years of age;
✓. Patients with planned thoracolumbar (any number of levels between T1 and the pelvis) spine fusion surgery and available preoperative standing lateral radiographs, inclusive of the femoral head axis;
✓. Able to undergo surgery based on physical exam, medical history and surgeon judgment;
✓. Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation.

Exclusion criteria

✕. Patient has a mental or physical condition that would limit the ability to comply with study requirements;
✕. Patient is a prisoner;
✕. Patient is participating in another clinical study that would confound study data.

What they're measuring

Evaluate the utility of alignment planning using surgical planning software

Timeframe: Postoperative (3 months)

Trial details

NCT IDNCT02606695

SponsorNuVasive

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More Spine Surgery trials