Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages

NCT05182489 | Active Not Recruiting FDA Device

• 1 other identifier: 2021H0244
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Timing of fusion

  24 months

Study Arms (2)

Medtronic Adaptix™ titanium implants

EXPERIMENTAL

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

Medtronic CAPSTONE® PEEK cage

ACTIVE COMPARATOR

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

Interventions

Medtronic Adaptix™ titanium implants DEVICE

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 Adaptix™ titanium implants

Medtronic CAPSTONE® PEEK cage DEVICE

Medtronic CAPSTONE® PEEK cage

Medtronic CAPSTONE® PEEK cage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center Neurological Surgery

Columbus, Ohio, 43219, United States

Location

Related Publications (17)

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MeSH Terms

Conditions

Spinal Stenosis; Spondylolisthesis; Osteophyte; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis; Exostoses; Hyperostosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be blinded to their group status for the duration of the study assessments and procedures (24 months post-operatively).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All subjects will be randomized in the trial 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. Subject randomization will be stratified according to smoking status. Subjects will be blinded to their group status for the duration of the study assessments and procedures (24 months post-operatively).

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 10, 2022
• Study Start: November 19, 2021
• Primary Completion: October 1, 2025
• Study Completion: April 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2025-06

Locations

US (1)