71 - Novel 3D Printed PEKK Interbody Devices: Positive Results from a Non-Randomized, Prospective Study

Saturday, June 3, 2023

11:30 AM – 11:32 AM

Location: Salons 10-12

Co-Author(s)

GC

G. Bryan Cornwall, PhD, MBA, PEng

Surgalign
San Diego, California, United States

Co-Author(s)

JO

Joseph R. OBrien, MD, MPH

Clinical Associate Professor
Aligned Orthopaedics
Bethesda, Maryland, United States
KS

K Brandon Strenge, MD

Orthopaedic Spine Surgeon
The Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States
CK

Christopher K. Kepler, MD, MBA

Associate Professor
Rothman Orthopaedic Institute, United States
JB

John Barker, MD

Rocky Mountain Spine Clinic
Lone Tree, Colorado, United States
GS

Gregory D. Schroeder, MD

Associate Professor
Rothman Orthopaedic Institute, United States
ST

Stacie Tran

United States

Submitter(s)

GC

G. Bryan Cornwall, PhD, MBA, PEng

Surgalign
San Diego, California, United States

Presenting Author (Person doing the Podium Present(s)

SS

Sophia Sangiorgio

United States

Introduction. Interbody fusion (IBF) implants support alignment, stability, and facilitate fusion. This study evaluates an FDA-cleared and CE-marked, 3-D printed polymer-based IBF devices, indicated for use in cervical and lumbar procedures. The IBF implants are fabricated with polyetherketoneketone (PEKK) and provides a nano-roughened surface.
Methods. A two-year prospective, multi-center, non-randomized post-market study evaluating safety and performance of the PEKK IBF devices. There are three arms in the study with 50 patients enrolled in each arm; one for cervical, and two for lumbar: C, TS, and L, respectively. Fusion rates and clinical outcomes including Visual Analog Scale (VAS), Short Form 12 (SF-12), Oswestry Disability Index (ODI), and Neck Disability Index (NDI) were analyzed within each arm of the study. This study is on clinicaltrials.gov (NCT03761563).

Results. 151 subjects were enrolled at 14 sites in the United States: 51 subjects in C, 50 subjects in each TS and L. 6-month fusion rate in the C group was 82%, which is comparable to published ACDF results where average fusion rate at 1 year was 90%. The 12-month fusion rate for the lumbar arms, TS and L, were also favorable at 95.8% and 100%, respectively as summarized in Table 1. Low reported reoperation rates in both TS and L groups, and none in the C group. VAS, ODI, NDI, and SF-12 Physical component scores significantly improved from baseline at every follow-up visit (All p< 0.05) and are summarized in Figure 1.

Conclusions. Fusion results are similar to published literature. Pain and disability outcomes were significantly improved, with low reoperation rates. The PEKK IBF devices are safe and effective to support fusion in the cervical and lumbar spine.