3D Printed Custom Made

Bone Solutions

(clinical implementation)

Joris J.W. Ploegmakers, MD, PhD

Department of Orthopaedic Surgery

Complex orthopaedic reconstruction

Revision PJI Oncology

University Medical Center Groningen

J.J.W.Ploegmakers@UMCG.Nl

The author declares that the research for and communication of this independent body of work does not constitute any financial or other conflict of interest.UMCG-employed

StrykerKCI

Disclosure statement

Introduction

• Physiology of bone and homeostasis• Classic surgical innovations• New possibilities• “Tips & Tricks”

Physiology

4-types of cells: form-maintain-remodel

Osteogenic cell Osteoblast Osteocyte Osteoclast

1. Osteogenic(Formation of new bone by the cells contained within the graft)

2. OsteoinductivityChemically active process: Ability to promote cellular functions leading to new bone

formation.

(Bone Morphogenetic proteins convert cells into bone forming cells. Active process)

3. Osteoconductivity(Physically: using a scaffold, for growing bone from host bone)

The ability of a scaffold to facilitate new bone formation in direct apposition to the

biomaterial by allowing attachment, proliferation, migration and phenotypic expression

of bone cells. Passive process

Definition

Osteopromotive (DBMs)

Osteostimulative(bioglass)

Osteosupportive (hybrid )

Stability

DefinitionThe perfect graft

Elliot D.A. et al. A unified theory of bone healing an donunion. BJJ 2016

Pentagon Model

OsteoinductiveBMP7 BMP2 TGF-β FGF

Giannoudis PV et al. Fracture healing: the diamond concept. Injury 2007: 38Giannoudis PV et al. The diamond concept-open questions. Injury 2008: 39

Critical Size Defect

Pentagon Model

Giannoudis PV et al. Fracture healing: the diamond concept. Injury 2007: 38Giannoudis PV et al. The diamond concept-open questions. Injury 2008: 39

Growth factorsBMP7 BMP2 TGF-β FGF

2014 2014 2014 2017

Graft

1668 First bone graft (v Meekeren)

1912 Nobel Prize (vasc anasto)

1945 First bone bank (VS)

1953 Substitute (Osteo-RCT)**

1960 Dutch bone bank -20°C

1979 BIG (T. Slooff)*Rusell A. Hibbs, An operation for progressive spinal deformities, NY Med J93(1911):1013-16.

**Leonard F. Peltier. The Use of Plaster of Paris to Fill Defects in Bone, Clin Orthop 21 (1961):1-31.

GraftGraft Modality Substance / implant Osteo genic Osteo ind Osteo conduct Remodeling Structural support

Autograft Cancellous bone +++ ++ +++ +++ -

Cortical bone + +/- +/- ++ ++

Bone marrow aspirate ++ +/- - - -

Allograft Fresh - +/- ++ + ++

Frozen - +/- + - ++

Cancellous bone - +/- + - +

Demineralized bone matrix - +/- + - +

Ceramics Hydroxyapatite - - + - +/-

TriCalciumPhosphate - - + - +/-

Growth factors BMP-2 BMP-7 - ++ - - -

PMMA - - - - +++

Scaffold + AB

Scaffold

Graft implanted Acute inflam

Chronic inflam

Bone formation

(fusion)

Angiogenesis

Scar tissue

(no fusion)

0

hrs

24

hrs

72

hrs

3

wks

6 - 12

wks

Coagulation

0

hrs

24

hrs

72

hrs

3

wks

6 - 12

wks

Inflammation

Neutrophils

Maturation & remodeling

VascularisationMacrophages

Granulation tissue

Lukas A. van Dijk Biphasic calcium phosphate with submicron surface topography

in an Ovine model of instrumented posterolateral spinal fusion. JOR Spine 2018 .

Classical solutions & limitations

Intercalary allograft

pro’s & cons

Biology ? Ingrowth 2mm > depends vascPreserves joint Preserves function Long rehabLong lasting Failure

2012 2013

2014 2015 2016

Vascularised fibula

pro’s & consbiology Non weight bearing vascularised OR time

54% thrombose 1/60Necrosis 9/60Graft # 13/60

BJJ 2017. Houdek MT. The outcome and complications of vascularised fibular grafts., Bayne CO, Bishop AT, Shin AY.Plast Recon Surg. 2002. Arai. Complications of vascularized fibula graft for reconstruction of long bones.

OR 12011 17 yr OstS.

It does not always heal

2015OR 2

2016OR 3

2017OR 4

2018OR 5

OR 6

2018 24 yr

Distraction osteogensis(Masquelet technique)

pro’s & consBiology vascularyt

Safe and effective (3-24cm)

Distraction histogenesis results in

functional matrix

No grafts required

Rehabilitatoin

Timely (Up to 2 yr)

2x OR

SSI

Pain & discomfort

Meticulous planning

Intercalary prosthesis

pro’s & cons Preserves joint 10 cm docking stemWeight bearing No biology

No vascularisation

120mm

100mm

J. I. Albergo. Failure rates and functional results for intercalary femur recon after

tumour resection. Muscul surg 2019.

Classical solutions & limitations

Ongrowth: 2 mmRemodeling: 10*-35** mm (1 year) BIG vascA femur is not a tibia (femur osteo distraction < tibia)#,##

Biology / Angiogenesis is time consuming

*Butscheidt. Incorporation and Remodeling of Structural Allografts in Acetabular Reconstruction: Multiscale, Micro-Morphological Analysis of 13 Pelvic Explants. JBJS Am 2018. **Sörensen. Rapid bone and blood flow formation in impacted morselized allografts: positron emission tomography (PET) studies on allografts in 5 femoral component revisions of total hip arthroplasty. Acta OS 2003. # Houdek MT The outcome and complications of vascularised fibular grafts. BJJ 2017.## Arai Complications of vascularized fibula graft for reconstruction of long bones. Plast Reconstr Surg. 2002.

We would like to see this

2014

2013. 57yr, PJI

HypothesisProblems:Compromised soft tissueTime is of essence

Biological affinity Durable Loadable Resistant to Infection

Amputation NA +++ + +

Prosthesis - + +++ -

Allograft + -/+ - -

Fibula +++ ++ - +

Allo + Fib ++ ++ + -/+

Osteo distr +++ ++ - +

Cage prost ++ ++ ++ -/+

Goal:Early mobilisation by stabilityBiological incorporation for durabilityBiological incorporation for PI prevention

1. Measurements “bone defect”

2. Plan CT3. Planning with tech

14 yr, OstSarc

Bram Merema

1. Measure “ bone defect”2. Plan CT3. Planning with technicians4. ComSol

1. Measure “ bone defect”2. Plan CT3. Planning with technicians4. ComSol5. Discuss concept6. Improve

Autograft

Reamer Irrigator Aspirator

*Marchand LS et al. Is This Autograft Worth It?: The Blood Loss and Transfusion Rates Associated With Reamer Irrigator Aspirator Bone Graft Harvest. J Orthop Trauma. 2017 Apr;31(4):205-209.

30cc

Scaffold + AB

Scaffold

2-stage due to #

FDG Pet 18

Work proces1. Measure “critical bone defect”2. Plan CT3. Planning with technicians4. ComSol5. Discuss concept6. Improve7. Plan CAS & 3d8. Work-process CE

Work-proces CE

Tips & Tricks• Start with easy cases (C spacer / 3d guides / C implant)• Take time to plan (from CT to sterilisation, 6wk)• Take time to plan (CAS)• Certify work- process (May 2020 new legislation)

J.J.W.Ploegmakers@UMCG.Nl

UnfortunatelyMechanostat

1. Instability2. No remodelling

hypertrofic non-union3. Implant failure

Questions

J.J.W.Ploegmakers@UMCG.Nl

2018, 28y OstSarc

Work process example• Plan Ct

• Technician• CE certification

• CAS + custom guide

Work process example