Basics of Cartilage Restoration Introduction of TruFit

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1 Basics of Cartilage Restoration Introduction of TruFit Philip A. Davidson, MD Heiden Orthopaedics Park City, Utah USA Smith & Nephew Seminar London, UK October 2008

2 Cartilage Restoration A wide realm between.. Arthroscopic debridement

3 Goals: Biological Cartilage Restoration Relieve pain Restore functional histologic architecture Improve Mechanics Long lasting Prevent or Limit Future Degenerative Changes

4 Goal of Cartilage Restoration Replicate Hyaline Articular Cartilage

5 Common Biological Treatment Options for Cartilage Defects < 1 cm cm 2 >4 cm 2 MST Mosaicplasty Debridement MST Mosaicplasty Allo OAT Chondrocytes MST Allo OAT Chondrocytes

6 Techniques - Drilling - Picking - Abrasion - Microfracture Marrow Stimulation Marrow stimulation results: - Fibrocartilage Limited potential with increased age, injury chronicity Cheap, fast, easy Short term efficacy seductive.

7 Biological Options Autologous Chondrocytes ACI MACI Osteochondral Grafts Autogenous Allogeneic Biologically Active Scaffolds

8 Additional biologic treatment options Minced allografts Enhanced autografts Hydrogels Orthobiologic Scaffolds SNE- OBI plugs Biomet - Osseofit

9 Comprehensive Knee Treatment Articular Cartilage restoration not in isolation Stability Alignment Meniscal status

10 What is needed for osteochondral healing? Scaffolds: Orthobiologic Implant Stimulants: Wound Site Surgical Technique + Rehab Cells:Patient

11 ORTHOBIOLOGICS Tissue engineering concept integrative Scaffold Cells/genes Bioactive agents/molecules/ factors

12 Where does orthobiologic osteochondral scaffold fit in? Off the shelf alternative better than microfracture Less morbidity than mosaicplasty Fill donor sites mosaicplasty No allograft donor issues Smaller type defects < appx 2cm

13 Orthobiologic graft has several appealing features No bridges burned Immediate smoothing Easy technique Readily available Minimally invasive Biological alternative Immediate Pain relief No risk of disease transmission Patient acceptance

14 Orthobiologic Scaffold- How it Works Keeps blood / cells where they need to be during healing Solid construct prevents formation of fibrous tissue Clean cut / press fit gives good host-implant contact Optimized pore size for chondrocyte and cellular migration Provides gradual loading as tissue matures

15 What does the Plug Provide? Multilayered product Each layer is designed to match the physical and mechanical properties of the adjacent tissue Absorbable Composed of: Poly(D,L-lactide-coglycolide) Calcium sulfate PGA fibersreinforcement beams Trace amount of surfactant articular cartilage tidemark subchondral bone

16 TRUFIT CB Plugs Preformed circular plugs with diameters ranging from 5 to 11 mm Ideal for filling circular drill holes in bone, 6-17 mm deep Allows for tissue regeneration Press fit into defect site to maintain space Patent 5,607,474 plus others issued and pending

17 TRUFIT CB Angled Plugs Treatment of osteochondral defects of the medial or lateral aspect of the talus Offered in 5 mm, 7 mm and 9 mm Custom delivery devices and defect creation tools for accurate installation of the implants

18 TRUFIT CB Saddle Plug Plug geometry mimics trochlea surface Clear outer sleeve to aid in visualization Available in 2 diameters: 9 and 11mm Markings at ends help in orientation

19 6 Weeks post-op Blood, marrow, cells are contained in pores Intimate contact to promote good contact and enhance integration Entire scaffold is filled with new tissue Defect walls are maintained Bone is infiltrating the scaffold from the periphery

20 Preclinical Testing 6 months-trochlear groove and medial femoral condyle

21 Preclinical Testing 12 months histology Treated with TruFit Empty - femoral condyle Jackson, et al. trochlear groove femoral condyle

22 Preclinical Testing 12 months histology close-ups trochlear groove femoral condyle Repair tissue exhibits normal cellular structure Stains positively for type II collagen

23 Thank You

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