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Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05182489
Recruitment Status : Recruiting
First Posted : January 10, 2022
Last Update Posted : January 10, 2022
Sponsor:
Information provided by (Responsible Party):
Andrew Grossbach, Ohio State University

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.

Condition or disease Intervention/treatment Phase
Spinal Canal Stenosis Spondylolisthesis Osteophyte Bony Growth Formation Degenerative Disc Disease Device: Medtronic Adaptix™ titanium implants Device: Medtronic CAPSTONE® PEEK cage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Single (Participant)
Masking Description: Subjects will be blinded to their group status for the duration of the study assessments and procedures (24 months post-operatively).
Primary Purpose: Treatment
Official Title: Lumbar Fusion With Micro and Nano-textured Titanium Interbody Cages - A Single-Blinded Randomized Controlled Trial Evaluating Adaptix™ Versus PEEK Cages
Actual Study Start Date : October 13, 2021
Estimated Primary Completion Date : November 23, 2024
Estimated Study Completion Date : January 23, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
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.

Active Comparator: 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).
Device: Medtronic CAPSTONE® PEEK cage
Medtronic CAPSTONE® PEEK cage




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Timing of fusion [ Time Frame: 24 months ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Subject must be over the age of 18 years old.
  3. Subject has been unresponsive to conservative care for a minimum of 6 months.
  4. 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:

  1. Subjects with previous lumbar arthrodesis surgery.
  2. Subjects requiring additional bone grafting materials other than local autograft bone or GRAFTON™ DBM DBF.
  3. Subject has inadequate tissue coverage over the operative site.
  4. Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.
  5. Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).
  6. Subject has an active local or systemic infection.
  7. Subject has a metal sensitivity/foreign body sensitivity.
  8. Subject is allergic to antibiotics (gentamicin) or processing solutions found in GRAFTON™.
  9. Subject is morbidly obese, defined as a body mass index (BMI) greater than 45.
  10. Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
  11. Subject is currently involved in another investigational drug or device study that could confound study data.
  12. 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.
  13. Subjects who are pregnant or plan to become pregnant in the next 12 months or who are lactating.
  14. Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain.
  15. Subject is a prisoner.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05182489


Contacts
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Contact: Shukri Ahmed, MPH 6143663439 shukri.ahmed@osumc.edu
Contact: Shelby Miracle 6143661648 shelby.miracle@osumc.edu

Locations
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United States, Ohio
The Ohio State University Wexner Medical Center Neurological Surgery Recruiting
Columbus, Ohio, United States, 43219
Contact: Shukri Ahmed    614-366-3439    shukri.ahmed@osumc.edu   
Contact: Shelby Miracle    614-366-1648    shelby.miracle@osumc.edu   
Sponsors and Collaborators
Ohio State University
Publications:

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Responsible Party: Andrew Grossbach, Principal Investigator, Ohio State University
ClinicalTrials.gov Identifier: NCT05182489    
Other Study ID Numbers: 2021H0244
First Posted: January 10, 2022    Key Record Dates
Last Update Posted: January 10, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spondylolisthesis
Spinal Stenosis
Osteophyte
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis
Exostoses
Hyperostosis