Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05182489
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ohio State University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spinal Canal Stenosis, Spondylolisthesis, Osteophyte, Bony Growth Formation, Degenerative Disc Disease

Additional Details

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.

Arms & Interventions

Arms

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).

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).

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Columbus, Ohio

Status

Recruiting

Address

The Ohio State University Wexner Medical Center Neurological Surgery

Columbus, Ohio, 43219

Site Contact

Shukri Ahmed

[email protected]

614-366-3439

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