ACTIVE_NOT_RECRUITING

Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages

Conditions

Spinal Canal Stenosis Spondylolisthesis Osteophyte Bony Growth Formation Degenerative Disc Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-11-19

Study Completion:2026-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05182489

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Locations (Sites)

The Ohio State University Wexner Medical Center Neurological Surgery

Columbus, Ohio, 43219

United States

Collaborators and Investigators

Sponsor: Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-19

Study Completion Date2026-04-01

Study Record Updates

Study Start Date2021-11-19

Study Completion Date2026-04-01

Terms related to this study

Additional Relevant MeSH Terms

Spinal Canal Stenosis
Spondylolisthesis
Osteophyte
Bony Growth Formation
Degenerative Disc Disease