An interventional study of Medtronic Adaptix™ titanium implants and Medtronic CAPSTONE® PEEK cage in Spinal Canal Stenosis, Spondylolisthesis and Osteophyte, sponsored by Ohio State University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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.
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.
459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 283 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
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Exclusion Criteria:
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).
Device: Medtronic Adaptix™ titanium implants
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).
Device: Medtronic CAPSTONE® PEEK cage
Patients who will be having a spinal fusion procedure as part of their standard of care treatment will be randomized to receive either the Medtronic titanium or the PEEK cage supplemented with a pedicle screw system and milled local autograft bone supplemented with GRAFTON DBM DBF. In order to assess fusion, patients will undergo a research-only CT Scan at 6 months post-surgery.
Medtronic CAPSTONE® PEEK cage
Fusion rate at 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.
Time frame: 6 months
Timing of fusion
Secondary measures of effectiveness will be determined by the principal investigator by evidence and timing of fusion observed in X-rays post-operatively (3, 6, 12, and 24 months).
Time frame: 24 months
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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