Nanotube vs Titanium Cage for Lumbar Fusion

FF
Overseen ByFrancis Farhadi, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is comparing two FDA-approved cages used during lower back surgery. The study will look at whether one cage helps the bones in the back fuse together better than the other. Adults who are having a 1 or 2 level lumbar fusion surgery will be randomly assigned to receive either the Adaptix nanoPEEK cage or the Capstone PTC cage. Participants will have follow-up visits with imaging and questionnaires to evaluate bone fusion, back and leg pain, physical function, and overall health.

Are You a Good Fit for This Trial?

This trial is for adults who need lower back surgery (lumbar fusion) at one or two levels due to degenerative disc disease. Participants must be eligible for this type of surgery and able to attend follow-up visits.

Inclusion Criteria

I have degenerative disc disease in my lower back confirmed by scans and history.
I am able to follow study instructions and attend all required visits.
Subject is able to provide written informed consent
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Exclusion Criteria

I have poor tissue coverage or an open wound at my surgery site.
I need extra bone graft materials besides my own bone for my procedure.
I have osteoporosis or severe bone loss with a history of fractures.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lumbar fusion surgery with either the Adaptix nanoPEEK cage or the Capstone PTC cage

Surgery day
1 visit (in-person)

Follow-up

Participants are monitored for spinal fusion progress and device condition with imaging and questionnaires

24 months
Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Adaptix nanoPEEK Cage
  • Capstone PTC Cage

Trial Overview

The study compares two types of cages used in lumbar fusion surgery: the Adaptix nanoPEEK cage and the Capstone PTC cage. Patients are randomly assigned to receive one of these devices during their procedure.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Adaptix nanoPEEK CageExperimental Treatment1 Intervention
Group II: Capstone PTC CageActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Francis Farhadi

Lead Sponsor

Trials
2
Recruited
330+