Compositions and methods for arthrodetic procedures

1. A method of performing an arthrodetic procedure on a subject comprising:

a step of applying to a site of desired bone fusion in a joint a composition comprising a platelet derived growth factor (PDGF) solution and a biocompatible matrix, wherein the solution is disposed in the biocompatible matrix;

wherein the biocompatible matrix comprises either a bone scaffolding material or comprises a bone scaffolding material and a biocompatible binder;

wherein the bone scaffolding material comprises β-tricalcium phosphate (β-TCP) having interconnected pores; and

wherein the method promotes fusion of bones of the joint.

2. The method of claim 1 , wherein the biocompatible binder is selected from the group consisting of: collagen, polysaccharides, carbohydrates, poly(α-hydroxy acids), poly(lactones), poly(amino acids), poly(anhydrides), polyurethanes, poly(orthoesters), poly(anhydride-co-imides), poly(orthocarbonates), poly(α-hydroxy alkanoates), poly(dioxanones), poly(phosphoesters), polylactic acid, poly(L-lactide) (PLLA), poly(D,L-lactide) (PDLLA), polyglycolide (PGA), poly(lactide-co-glycolide (PLGA), poly(L-lactide-co-D,L-lactide), poly(D,L-lactide-co-trimethylene carbonate), polyglycolic acid, polyhydroxybutyrate (PHB), poly(ε-caprolactone), poly(δ-valerolactone), poly(γ-butyrolactone), poly(caprolactone), polyacrylic acid, polycarboxylic acid, poly(allylamine hydrochloride), poly(diallyldimethylammonium chloride), poly(ethyleneimine), polypropylene fumarate, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene, polymethylmethacrylate, carbon fibers, poly(ethylene glycol), poly(ethylene oxide), poly(vinyl alcohol), poly(vinylpyrrolidone), poly(ethyloxazoline), poly(ethylene oxide)-co-poly(propylene oxide) block copolymers, poly(ethylene terephthalate)polyamide, alginic acid, arabic gum, guar gum, xantham gum, gelatin, chitin, chitosan, chitosan acetate, chitosan lactate, chondroitin sulfate, lecithin, N,O-carboxymethyl chitosan, phosphatidylcholine derivatives, a dextran, fibrin glue, glycerol, hyaluronic acid, sodium hyaluronate, a cellulose, a glucosamine, a proteoglycan, a starch, lactic acid, a pluronic acid, sodium glycerophosphate, glycogen, a keratin, silk, and copolymers and mixtures thereof.

3. The method of claim 2 , wherein the biocompatible binder comprises collagen.

4. The method of claim 1 , wherein the PDGF concentration is about 0.1 to about 1.0 mg/ml.

5. The method of claim 1 , wherein the PDGF concentration is about 0.3 mg/ml.

6. The method of claim 1 , wherein the PDGF comprises PDGF-BB.

7. The method of claim 1 , wherein the PDGF comprises recombinant human PDGF-BB (rhPDGF-BB).

8. The method of claim 1 , wherein the rhPDGF-BB comprises at least 65% intact rhPDGF-BB.

9. The method of claim 1 , wherein the bone scaffolding material comprises particles having an average diameter of: from about 100 microns to about 5000 microns, from about 1000 microns to about 2000 microns; or from about 100 microns to about 300 microns.

10. The method of claim 1 , wherein the bone scaffolding material comprises a porosity greater than about 50%.

11. The method of claim 1 , wherein the bone scaffolding material comprises a porosity greater than about 90%.

12. The method of claim 1 , wherein the bone scaffolding material comprises macroporosity.

13. The method of claim 1 , wherein the bone scaffolding material comprises a porosity that facilitates osteoinduction and osteoconduction into the biocompatible matrix.

14. The method of claim 1 , wherein the arthrodetic procedure further comprises the additional steps of aligning the bones to be fused and inserting at least one screw into at least one bone or of the joint.

15. The method of claim 1 , wherein the arthrodetic procedure comprises an arthrodetic procedure of the foot and ankle.

16. The method of claim 1 , wherein the arthrodetic procedure comprises a subtalar arthrodesis, a talonavicular arthrodesis, a triple arthrodesis, or an ankle arthrodesis.

17. The method of claim 1 , wherein the site of the desired bone fusion is selected from the group consisting of a subtalar joint, a talonavicular joint, a calcaneocuboid joint, and an ankle joint.

18. The method of claim 1 , wherein the arthrodetic procedure comprises a spinal arthrodetic procedure.

19. The method of claim 1 , wherein the biocompatible matrix consists of the bone scaffolding material and collagen.

20. The method of claim 19 , wherein the PDGF concentration is about 0.1 to about 1.0 mg/ml.

21. The method of claim 19 , wherein the PDGF concentration is about 0.3 mg/ml.

22. The method of claim 19 , wherein the PDGF comprises PDGF-BB.

23. The method of claim 19 , wherein the PDGF comprises recombinant human PDGF-BB (rhPDGF-BB).

24. The method of claim 19 , wherein the rhPDGF-BB comprises at least 65% intact rhPDGF-BB.

25. The method of claim 19 , wherein the bone scaffolding material consists of particles having an average diameter of: from about 100 microns to about 5000 microns; from about 100 microns to about 300 microns; or from about 1000 microns to about 2000 microns.

26. The method of claim 19 , wherein the bone scaffolding material comprises a porosity greater than about 50%.

27. The method of claim 19 , wherein the bone scaffolding material comprises a porosity greater than about 90%.

28. The method of claim 19 , wherein the bone scaffolding material comprises macroporosity.

29. The method of claim 19 , wherein the bone scaffolding material comprises a porosity that facilitates osteoinduction and osteoconduction into the biocompatible matrix.

30. The method of claim 19 , wherein the collagen comprises Type I collagen.

31. The method of claim 19 , where the ratio of collagen: β-tricalcium phosphate is about 20:80 by weight.

32. The method of claim 1 , wherein the bone scaffolding material consists of particles having an average diameter from about 100 to about 5000 microns, wherein the PDGF concentration is about 0.1 to about 1.0 mg/ml, and wherein the PDGF comprises rhPDGF-BB.

33. The method of claim 32 , wherein the β-tricalcium phosphate comprises a porosity greater than about 50%.

34. The method of claim 32 , wherein the PDGF concentration is about 0.3 mg/ml.

35. The method of claim 32 , wherein the arthrodetic procedure further comprises the additional steps of aligning the bones to be fused and inserting at least one screw into at least one bone of the joint.

36. The method of claim 32 , wherein the arthrodetic procedure comprises an arthrodetic procedure of the foot and ankle.

37. The method of claim 36 , wherein the arthrodetic procedure comprises a subtalar arthrodesis, a talonavicular arthrodesis, a triple arthrodesis, or an ankle arthrodesis.

38. The method of claim 32 , wherein the site of the desired bone fusion is selected from the group consisting of a subtalar joint, a talonavicular joint, a calcaneocuboid joint, and an ankle joint.

39. The method of claim 32 , wherein the arthrodetic procedure comprises a spinal arthrodetic procedure.

40. The method of claim 1 , wherein the bone scaffolding material consists of particles having an average diameter from about 100 to about 300 microns, wherein the PDGF concentration is about 0.1 to about 1.0 mg/ml, and wherein the PDGF comprises rhPDGF-BB.

41. The method of claim 40 , wherein the β-tricalcium phosphate comprises a porosity greater than about 50%.

42. The method of claim 40 , wherein the PDGF concentration is about 0.3 mg/ml.

43. The method of claim 40 , wherein the arthrodetic procedure further comprises the additional steps of aligning the bones to be fused and inserting at least one screw into at least one bone of the joint.

44. The method of claim 40 , wherein the arthrodetic procedure comprises a spinal arthrodetic procedure.

45. The method of claim 1 , wherein the bone scaffolding material consists of particles having an average diameter from about 1000 to about 2000 microns, wherein the PDGF concentration is about 0.1 to about 1.0 mg/ml, and wherein the PDGF comprises rhPDGF-BB.

46. The method of claim 45 , wherein the @-tricalcium phosphate comprises a porosity greater than about 50%.

47. The method of claim 45 , wherein the PDGF concentration is about 0.3 mg/ml.

48. The method of claim 45 , wherein the arthrodetic procedure further comprises the additional steps of aligning the bones to be fused and inserting at least one screw into at least one bone of the joint.

49. The method of claim 45 , wherein the arthrodetic procedure comprises a spinal arthrodetic procedure.

50. The method of claim 1 , wherein the bone scaffolding material consists of particles having an average diameter from about 250 to about 1000 microns, wherein the PDGF concentration is about 0.1 to about 1.0 mg/ml, and wherein the PDGF comprises rhPDGF-BB.

51. The method of claim 50 , wherein the arthrodetic procedure further comprises the additional steps of aligning the bones to be fused and inserting at least one screw into at least one bone of the joint.

52. The method of claim 50 , wherein the arthrodetic procedure comprises a spinal arthrodetic procedure.

53. The method of claim 1 , wherein the composition is flowable, moldable, and/or extrudable.

54. The method of claim 1 , wherein the composition is flowable, moldable, and/or injectable.

55. The method of claim 1 , wherein the composition is moldable, extrudable, and/or injectable.