Advanced Materials Science in XLIF Study (NCT03649490) | Clinical Trial Compass
By InvitationNot Applicable
Advanced Materials Science in XLIF Study
United States300 participantsStarted 2018-08-19
Plain-language summary
This study is being conducted to evaluate the clinical and radiographic outcomes of three different interbody implant types when used with cancellous allograft chips with BMA or cellular allograft in patients undergoing XLIF surgery. The study will evaluate success by comparing the rate of fusion, complications profile, and any relationships between clinical outcomes (pain and function) and radiographic outcomes (fusion rate) between the three implant groups.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Male and female patients who are 18-80 years of age;
✓. Planned interbody fusion surgery, including at least one level of extreme lateral interbody fusion (XLIF) prior to enrollment in the research at one or two consecutive lumbar levels for degenerative disc disease, including those with up to Grade 2 spondylolisthesis, with one of the following NuVasive, Inc. interbody implants:
✓. Coroent® XL PEEK interbody implant; or
✓. Modulus® 3D-printed titanium interbody implant; or
✕. Use of BMP, synthetic bone graft substitutes, allografts, or any other graft material in the interbody or intrafacet spaces other than those under study;
✕. Posterior grafting other than the allowed intrafacet fusion at the treated level(s);
✕. Revision of prior fusion at treated level(s) (adjacent level interbody fusion is acceptable);
✕. XLIF procedure that requires or results in the release of the anterior longitudinal ligament or posterior osteotomy;