Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages

The randomized controlled trial will prospectively evaluate the efficacy of Medtronic Adaptix™ titanium implants supplemented with a pedicle screw system as compared to a Medtronic CAPSTONE® PEEK cage currently used in routine fashion for lumbar interbody fusion procedures. This study will capture clinical and radiographic outcomes on patients up to 2 years postoperatively. Both cages will be used in conjunction with a 50:50 mixture of autograft: allograft using milled local autograft bone and GRAFTON™ DBM DBF (no iliac crest autograft will be utilized).

This single-centered study will enroll up to 100 subjects, with subjects followed for 24 months post-surgery. All subjects enrolled in the study will be recruited from a pool of subjects eligible for combined interbody/posterolateral lumbar fusion surgery. The inclusion/exclusion criteria are listed below.

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.
• Subject must be over the age of 18 years old.
• Subject has been unresponsive to conservative care for a minimum of 6 months.
• 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

• Subjects with previous lumbar arthrodesis surgery.
• Subjects requiring additional bone grafting materials other than local autograft bone or GRAFTON™ DBM DBF.
• Subject has inadequate tissue coverage over the operative site.
• Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.
• Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).
• Subject has an active local or systemic infection.
• Subject has a metal sensitivity/foreign body sensitivity.
• Subject is allergic to antibiotics (gentamicin) or processing solutions found in GRAFTON™.
• Subject is morbidly obese, defined as a body mass index (BMI) greater than 45.
• Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
• Subject is currently involved in another investigational drug or device study that could confound study data.
• Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
• Subjects who are pregnant or plan to become pregnant in the next 12 months or who are lactating.
• Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain.
• Subject is a prisoner.