Lumbar Fusion With Nanotube Versus Titanium Cage
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFrancis Farhadi
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is scheduled to undergo 1- or 2-level TLIF with the principal investigator.
Subject has failed nonoperative management for a minimum of 3 months prior to enrollment.
Diagnosis is degenerative disc disease (DDD), defined as discogenic back pain with disc degeneration confirmed by history and radiographic studies, at 1 or 2 contiguous spinal levels from L2 to S1. Subjects may have up to grade 1-2 spondylolisthesis or retrolisthesis at the index level(s).
Subject is able to provide written informed consent.
Disqualifiers
Prior lumbar arthrodesis surgery at any level.
Diagnosis of osteoporosis (T-score = -2.5) or severe osteopenia (T-score = -2.0 with fragility fracture history).
Body mass index (BMI) greater than 40 kg/m².
Requirement for additional bone grafting materials beyond milled local autograft bone (e.g., rhBMP-2, iliac crest autograft, allograft structural spacers).
Trial design
Design model
Parallel
Treatments tested in this trial
Adaptix nanoPEEK Cage
DeviceFDA- approved interbody cage used during lumbar fusion surgery.
Capstone PTC Cage
DeviceFDA- approved interbody cage used during lumbar fusion surgery.
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: Adaptix nanoPEEK CageExperimental treatment 1 intervention
Group B: Capstone PTC CageActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Radiographic Fusion
Radiographic fusion will be assessed using the Brantigan and Steffee classification as modified by Fraser (BSF Scale). Radiographic success is defined as BSF-3 fusion, with bone bridges present with at least half fusion area and at least the density originally achieved at surgery.
Time frame
6 Months After SurgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Francis Farhadi
Lead sponsor
University of Kentucky
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: