In this study, a novel custom-designed high-density nano-hydroxyapatite/polyamide (n-HA/PA) prosthesis with a polyvinyl alcohol (PVA) hydrogel humeral head surface was employed to repair the shoulder joint head for hemiarthroplasty in rabbits. The prosthesis was fabricated using three-dimensional computed tomography and computer-aided design and computer-aided manufacturing systems for perfect fitting. Sixteen New Zealand white rabbits underwent humeral head excision, and received the composite prostheses for hemiarthroplasty. The implant sites were free from suppuration and necrosis at all periods. The X-ray results showed that there was a clear space between the prosthesis head and the glenoid surface, and the joint capsules and surfaces of the glenoid and PVA were well preserved without any damage during the whole inspection period. A high density of bone was observed around the firmware part of the prosthesis. Histological results revealed that significant osteogenesis was surrounding the firmware part, and the joint space was clear and the cartilage of the upper joint surface was basically intact. There was no visible absorption of the joint surfaces even after 3 months of continuous functional motions. The maximum tensile strength between the prosthesis and host bone reached 2.63 MPa at the 12th week postimplantation. In conclusion, the customized prosthesis by combination of PVA and high-density n-HA/PA has excellent biocompatibility and biological fixation, and offers a promising substitute for both the cartilage and the bone of the humeral head in a rabbit model as level V evidence.
Keywords: Custom-designed prosthesis; Nano-hydroxyapatite/polyamide; Polyvinyl alcohol hydrogel; Shoulder hemiarthroplasty; Synovial joint.
Copyright © 2014 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.