title: [Manufacture and biocompatibility study of poly-D,L-lactic acid plate containing rhBMP-2].
abstract: OBJECTIVE
  To investigate the manufacture and biocompatibility of a bioabsorbable poly-D,L-lactic acid (PDLLA) plate containing rhBMP-2.
  
  
  METHODS
  rhBMP-2 was composited with PDLLA (0.05 mg/plate) through vacuum to prepare PDLLA plate containing rhBMP-2. Thirty-two New Zealand rabbits (male or female) weighted (3.0 +/- 0.5) kg were used in the study. A 2.5 mm middle ulna osteotomy was made bilaterally. The bones as well as periosteum were removed. The right side of all the animals was experimental side (n=32), was fixed internally by PDLLA plate containing rhBMP-2.The left side of all the animals was control side (n=32), was fixed by common PDLLA plate. After a follow-up of 2, 4, 8 and 12 weeks, the ulnas were examined visually, radiographically, histologically, and by computer graph analysis to compare the biocompatibility.
  
  
  RESULTS
  Porosity of PDLLA plate containing rhBMP-2 was 90%, aperture was 150 microm, tensile strength was higher than 50 MPa, three point flexural strength was higher than 90 MPa and intrinsic viscosity was 1.6 dL/g (chloroform solvent). All animals had a good healing 1 or 2 weeks after operation. All the animal's diet and movement were normal. All the fractures were stable. The plates in the experimental group degraded faster than those in the control group. Relative values of callus density evaluated by X-ray at 2, 4, 8 and 12 weeks after operation in the experimental group were 39.22 +/- 2.48, 48.79 +/- 1.26, 63.78 +/- 1.78 and 78.60 +/- 1.25 respectively. Those in the control defects were 33.83 +/- 1.13, 41.28 +/- 1.25, 55.23 +/- 0.68 and 66.54 +/- 1.33. At each time point, the experimental side produced better and more trabeculae than the control side did (P < 0.01). Histological examination showed that the new bone formation in the experimental side at 2, 4, 8 and 12 weeks after operation was 0.106% +/- 0.015%, 0.292% +/- 0.019%, 0.457% +/- 0.048% and 0.601% +/- 0.037%, while those in the control side was 0, 0.193% +/- 0.019%, 0.339% +/- 0.029% and 0.574% +/- 0.047% respectively. At each time point, the experimental side produced better new bone formation than the control side did (P < 0.05). The experimental side showed better compatibility between plates and surrounding tissue, faster bone formation, more bone regeneration mass and better medullary canal structure than the control side.
  
  
  CONCLUSIONS
  PDLLA plate containing rhBMP-2 has good biocompatibility and osteoinducibility to enhance fracture healing.
authors: Shanghai Institute for Microsurgery of Extremities, Shanghai, 200233, P.R. China.
authors: Shangchun
authors: S
authors: Guo
authors: Jinwu
authors: J
authors: Wang
authors: Cunyi
authors: C
authors: Fan
authors: Weifeng
authors: W
authors: Ni
authors: Bingfang
authors: B
authors: Zeng
authors: Xuesong
authors: X
authors: Li
mesh_terms: D000818:Animals; D001672:Biocompatible Materials / Q000737:chemistry; D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins; D001860:Bone Plates; D005260:Female; D005593:Fracture Fixation, Internal / Q000295:instrumentation / Q000379:methods*; D017102:Fracture Healing; D019344:Lactic Acid; D008297:Male; D010012:Osteogenesis; D011091:Polyesters; D011108:Polymers; D011817:Rabbits; D011994:Recombinant Proteins; D023822:Tissue Engineering / Q000379:methods*; D016212:Transforming Growth Factor beta; D014458:Ulna Fractures / Q000601:surgery*
chemical_list: D001672:Biocompatible Materials; D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins; D011091:Polyesters; D011108:Polymers; D011994:Recombinant Proteins; D016212:Transforming Growth Factor beta; C499469:recombinant human bone morphogenetic protein-2; D019344:Lactic Acid; C033616:poly(lactide)