porous titanium cervical implants.

Transcription

1 Preliminary results of quantitative functional X-ray analysis of CABO meeting 2017 stand-alone interbody 3D printed porous titanium cervical implants. Mark Arts, MD PhD Jasper Wolfs, MD Neurosurgery Department Haaglanden MC The Hague Netherlands Nancy Lamerigts, MD PhD VP Marketing & Research EIT

2 Disclaimer Mark Arts, MD PhD & Jasper Wolfs, MD Neurosurgery Department Haaglanden MC The Hague Netherlands EIT: Consultant Royalties Silony: Consultant Member Medical Advisory Board Zimmer-Biomet: Consultant Training & Education

3 Preliminary results EFFECT Trial Abstract SSA 2017 White paper Preliminary results of quantitative functional X-ray analysis of stand-alone EIT cervical implants in comparison to PEEK implants at 3 and 12 months follow up Mark Arts, MD PhD Haaglanden MC The Hague the Netherlands Jasper Wolfs, MD Haaglanden MC The Hague the Netherlands

4 Definition of fusion Imaging courtesy Cascade Trial Arts and Wolfs

5 Definition of fusion in ACDF Experts opinion: Always fusion Material not important Literature: Less than 4º motion? < 3 mm displacement? bridging bone? Imaging courtesy Cascade Trial Arts and Wolfs

6 Definition of fusion in ACDF Best way to show fusion: dynamic X-rays, analyzed by Medicalmetrics, FXA Imaging courtesy Cascade Trial Arts and Wolfs

7 Definition of fusion in ACDF Cochrane review 2004 & 2011 No superior treatment for cervical disc herniation No correlation clinical parameters and fusion Few studies Small studies Small sample sizes Generally poor research design Fusion measurement not described

8 EIT Cellular Titanium : First clinical experience cervical implant Advantages Very good grip / tight hold in disc space Porous microstructure No bone or substitute Good anatomical fit Good visibility on X-ray / CT / MRI Big surface less subsidence? Faster bone ingrowth?

9 EFFECT Trial Prospective trial of Porous Titanium Cervical Cages to analyze bone fusion capacity and NDI improvement. The EFFECT (Examination of Fast Fusion with EIT Cellular Titanium) Trial 50 consecutive patients receiving the EIT Cellular Titanium cervical cage Prospective follow up Clinical (NDI) and radiological parameters (FXA) Control group: 50 patients PEEK with autograft CASCADE trial.

10 EFFECT Trial Prospective trial of Porous Titanium Cervical Cages to analyze bone fusion capacity and NDI improvement. Primary Objective To evaluate the improvement of NDI 3, 6 and 12 months after surgery. Secondary Objective To evaluate fusion at several time points using lateral flexion-extension radiographs, analyzed by FXA (Functional X-Ray Analysis) of Aces GmbH.

11 EFFECT Trial Preliminary outcome Prospective trial of Porous Titanium Cervical Cages to analyze bone fusion capacity and NDI improvement. Preliminary radiological results of first 10 patients with 3 and 12 months follow up. Data compared with control group of CASCADE trial: PEEK versus SiN (accepted for publication in European spine journal and Clinical Orthopaedics and related research)

12 EFFECT Trial Preliminary outcome Prospective trial of Porous Titanium Cervical Cages to analyze bone fusion capacity and NDI improvement. EIT PEEK Mean ROM 3 months 2,8 (0,2-6,0) 3,4 (1,1-7,5) 12 months 1,2 (0,0-4,5) 1,8 (0,0-6,8) Mean Subsidence 6 months 1,24 mm 1,57 mm

13 FXA: analyses of motion / rotation 3 months post-op

14 FXA: analyses of motion / rotation 12 months post-op

15 FXA: Fusion percentage with ROM < % 89% PEEK EIT Percentage of fusion months 12 months PEEK: n=43 EIT: n=10 PEEK: n=41 EIT: n=9

16 FXA: Fusion percentage with ROM < % % PEEK EIT Percentage of fusion months 12 months PEEK: n=43 EIT: n=10 PEEK: n=41 EIT: n=9

17 Take home message Lack of uniformity in definition fusion Dynamic X-ray essential Fusion may be associated with outcome Results EFFECT trial: Promising results, to be continued end of 2017.

18 Thank you for your attention