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Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages

Primary Purpose

Spinal Canal Stenosis, Spondylolisthesis, Osteophyte

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Medtronic Adaptix™ titanium implants

Medtronic CAPSTONE® PEEK cage

About this trial

This is an interventional treatment trial for Spinal Canal Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

The Ohio State University Wexner Medical Center Neurological SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Medtronic Adaptix™ titanium implants

Medtronic CAPSTONE® PEEK cage

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Timing of fusion

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).

Full Information

NCT ID

NCT05182489

First Posted

December 9, 2021

Last Updated

February 22, 2023

Sponsor

Ohio State University

1. Study Identification

Unique Protocol Identification Number

NCT05182489

Brief Title

Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 13, 2021 (Actual)

Primary Completion Date

November 23, 2024 (Anticipated)

Study Completion Date

January 23, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Participant

Masking Description

Subjects will be blinded to their group status for the duration of the study assessments and procedures (24 months post-operatively).

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Medtronic Adaptix™ titanium implants

Arm Type

Experimental

Arm Description

Arm Title

Medtronic CAPSTONE® PEEK cage

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Medtronic Adaptix™ titanium implants

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Medtronic CAPSTONE® PEEK cage

Intervention Description

Medtronic CAPSTONE® PEEK cage

Primary Outcome Measure Information:

Title

Fusion rate at 6 months

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Timing of fusion

Description

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).

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shukri Ahmed, MPH

Phone

6143663439

shukri.ahmed@osumc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Shelby Miracle

Phone

6143661648

shelby.miracle@osumc.edu

Facility Information:

Facility Name

The Ohio State University Wexner Medical Center Neurological Surgery

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43219

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shukri Ahmed

Phone

614-366-3439

shukri.ahmed@osumc.edu

First Name & Middle Initial & Last Name & Degree

Shelby Miracle

Phone

614-366-1648

shelby.miracle@osumc.edu

12. IPD Sharing Statement

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Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages

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