Regeneration of diaphyseal bone defects using resorbable poly(L/DL-lactide) and poly(D-lactide) membranes in the Yucatan pig model.

Objectives: To determine the effects of tubular resorbable polymer membranes on the healing of a segmental diaphyseal bone defect.

Design: A randomized prospective study using the minipig model. Animals were evaluated with in vivo roentgenograms on a biweekly basis until explanted at twelve weeks.

Setting: After surgery, animals were allowed unrestricted activity and weight bearing between twenty-four and forty-eight hours.

Animals: Fifteen yearling Yucatan minipigs.

Intervention: A 2.5- to 3.0-centimeter mid-diaphyseal defect was created in the middle third of the radius. Animals were assigned in groups of three to receive the following implants: (a) poly(L/DL-lactide), (b) poly(L/DL-lactide)-CaCO3, (c) poly(D-lactide), (d) poly(D-lactide)-CaCO3, and (e) an untreated defect. No adjunctive internal or external fixation was used as the ulna was left intact.

Main Outcome Measures: The limbs were studied with in vivo anterior-posterior and lateral radiographs at biweekly intervals for the presence and pattern of bone formation. All limbs were explanted at twelve weeks postimplantation for methyl-methacrylate embedding and histologic and microradiographic study.

Results: The bone defects covered with membranes were completely reconstituted by six to eight weeks. Untreated defects healed with less bone formation and in a more disorganized pattern. Histologic evaluation of the implants demonstrated that the entire lumen of the implant was filled with bone, with some periosteal bone formation occurring on the outer surface of the membrane. There was direct apposition of bone onto the membrane surface or minimal fibrous tissue interposition between membrane and new bone. There was no foreign body or adverse reaction to the membrane. Untreated defects showed woven bone formation with clefts and irregularly shaped margins occupied by fibrous tissues or surrounding muscle tissues.

Conclusions: This study supports the concept that a membrane enhances bone defect healing by excluding nonosseous tissues from a defect and providing structural scaffolding for periosteal and endosteal bone regeneration.