Status:
ACTIVE_NOT_RECRUITING
Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages
Lead Sponsor:
Ohio State University
Conditions:
Spinal Canal Stenosis
Spondylolisthesis
Eligibility:
All Genders
18+ years
Phase:
NA
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, s...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05182489
Start Date
November 19 2021
End Date
April 1 2026
Last Update
June 25 2025
Active Locations (1)
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1
The Ohio State University Wexner Medical Center Neurological Surgery
Columbus, Ohio, United States, 43219