Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages
United States100 participantsStarted 2021-11-19
Plain-language summary
The purpose of this randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo combined interbody/posterolateral lumbar fusion procedures, supplemented with pedicle screw instrumentation, using one of the following interbody cages; the Medtronic Adaptix™ cage with roughened micro and nano-textured titanium surfaces or the CAPSTONE® poly-ether-ether-ketone cage.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is scheduled to undergo combined interbody and posterolateral spinal fusion surgery using either the Medtronic Adaptix™ titanium cage or Medtronic CAPSTONE® PEEK cage in conjunction with a 50:50 mixture of local autograft and GRAFTON™ DBM DBF, and supplementation with a pedicle screw system.
âś“. Subject must be over the age of 18 years old.
âś“. Subject has been unresponsive to conservative care for a minimum of 6 months.
âś“. The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
Exclusion criteria
âś•. Subjects with previous lumbar arthrodesis surgery.
✕. Subjects requiring additional bone grafting materials other than local autograft bone or GRAFTON™ DBM DBF.
âś•. Subject has inadequate tissue coverage over the operative site.
âś•. Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.
âś•. Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).
âś•. Subject has an active local or systemic infection.