Comparing two types of spinal fusion cages for surgery

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

This study is testing which type of spinal fusion cage, either the titanium or PEEK cage, works better for patients having back surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ohio State University (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT05182489 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial aims to evaluate the clinical and radiographic outcomes of patients undergoing combined interbody and posterolateral lumbar fusion procedures using either the Medtronic Adaptix™ titanium cage or the Medtronic CAPSTONE® PEEK cage. The study will follow up with participants for 24 months post-surgery to assess the effectiveness of these two interbody cages. A total of 100 subjects will be enrolled, all of whom must meet specific eligibility criteria related to their spinal conditions and previous treatments.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who have not responded to conservative care for at least 6 months and are scheduled for lumbar fusion surgery.

Not a fit: Patients who have previously undergone lumbar arthrodesis surgery or require additional bone grafting materials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients undergoing lumbar fusion surgery.

How similar studies have performed: Other studies comparing different types of interbody cages have shown promising results, suggesting that this approach is supported by existing evidence.

Eligibility 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.

Where this trial is running

Columbus, Ohio

• The Ohio State University Wexner Medical Center Neurological Surgery — Columbus, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Shukri Ahmed, MPH

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