Fortifying the Bone-Implant Interface Part 2: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants.

MacBarb RF et al.Int J Spine Surg. 2017;11:116-28. DOI: 10.14444/4016.

Abstract

Background
Minimally invasive surgical fusion of the sacroiliac (SI) joint using machined solid triangular titanium plasma spray (TPS) coated implants has demonstrated positive clinical outcomes in SI joint pain patients. Additive manufactured (AM), i.e. 3D-printed, fenestrated triangular titanium implants with porous surfaces and bioactive agents, such as nanocrystalline hydroxyapatite (HA) or autograft, may further optimize bony fixation and subsequent biomechanical stability.

Methods
A bilateral ovine distal femoral defect model was used to evaluate the cancellous bone-implant interfaces of TPS-coated and AM implants. Four implant groups (n=6/group/time-point) were included: 1)TPS-coated, 2)AM, 3)AM+HA, and 4)AM+Autograft. The bone-implant interfaces of 6- and 12-week specimens were investigated via radiographic, biomechanical, and histomorphometric methods.

Results
Imaging showed peri-implant bone formation around all implants. Push-out testing demonstrated forces greater than 2500 N, with no significant differences among groups. While TPS implants failed primarily at the bone-implant interface, AM groups failed within bone ~2-3mm away from implant surfaces. All implants exhibited bone ongrowth, with no significant differences among groups. AM implants had significantly more bone ingrowth into their porous surfaces than TPS-coated implants (p<0.0001). Of the three AM groups, AM+Auto implants had the greatest bone ingrowth into the porous surface and through their core (p<0.002).

Conclusions
Both TPS and AM implants exhibited substantial bone ongrowth and ingrowth, with additional bone through growth into the AM implants’ core. Overall, AM implants experienced significantly more bone infiltration compared to TPS implants. While HA-coating did not further enhance results, the addition of autograft fostered greater osteointegration for AM implants.

Clinical Relevance
Additive manufactured implants with a porous surface provide a highly interconnected porous surface that has comparatively greater surface area for bony integration. Results suggest this may prove advantageous toward promoting enhanced biomechanical stability compared to TPS-coated implants for SI joint fusion procedures.

Author Information
Regina F. MacBarb, PhD, Derek P. Lindsey, MS,1 Shane A. Woods, MS,2 Peggy A. Lalor, PhD,3 Mukund I. Gundanna, MD,4  Scott A. Yerby, PhD1

1 SI-BONE, Inc., San Jose, CA, USA, 2 MPI Research, Mattawan, MI, USA, 3 Histion LLC, Everett, WA, USA, 4 Brazos Spine, College Station, TX

Disclosures & COI
This study was funded by SI-BONE, Inc. RFM, DPL, and SAY are employees of SI-BONE, Inc. MIG is a consultant of SI-BONE, Inc. There are no other conflicts to report.