NCT05182489

Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages

Lumbar Fusion With Micro and Nano-textured Titanium Interbody Cages - A Single-Blinded Randomized Controlled Trial Evaluating Adaptix™ Versus PEEK Cages

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Canal Stenosis
• Spondylolisthesis
• Osteophyte
• Bony Growth Formation
• Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	Medtronic Adaptix™ titanium implants	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.
DEVICE	Medtronic CAPSTONE® PEEK cage	Medtronic CAPSTONE® PEEK cage

Timeline

• Start date: 2021-11-19
• Primary completion: 2025-10-01
• Completion: 2026-04-01
• First posted: 2022-01-10
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study