Lumbar Fusion With Micro and Nano-textured Titanium Interbody Cages - A Single-Blinded Randomized Controlled Trial Evaluating Adaptix™ Versus PEEK Cages
Overview
- Phase
- Not Applicable
- Intervention
- Medtronic Adaptix™ titanium implants
- Conditions
- Spinal Canal Stenosis
- Sponsor
- Ohio State University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Fusion rate at 6 months
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Andrew Grossbach
Principal Investigator
Ohio State University
Eligibility Criteria
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
- •Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
Arms & Interventions
Medtronic Adaptix™ titanium implants
This arm will use Medtronic Adaptix™ titanium implants supplemented with a pedicle screw system. 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).
Intervention: Medtronic Adaptix™ titanium implants
Medtronic CAPSTONE® PEEK cage
This arm will use Medtronic CAPSTONE® PEEK cage supplemented with a pedicle screw system. 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).
Intervention: Medtronic CAPSTONE® PEEK cage
Outcomes
Primary Outcomes
Fusion rate at 6 months
Time Frame: 6 months
A subject will be considered a success if fusion is a Grade BSF-3 at 6 months. The primary outcome measure of effectiveness will be determined by the fusion rate at 6 months post-operatively in subjects implanted with either titanium cage as compared to the PEEK cage.
Secondary Outcomes
- Timing of fusion(24 months)