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Resorbable calcium phosphate bone substitute

D Knaack1, M E Goad, M Aiolova

  • 1ETEX Corporation, Cambridge, Massachusetts 02139, USA.

Journal of Biomedical Materials Research
|December 17, 1998
PubMed
Summary

This study tested a new bone substitute made from calcium phosphate. The material is injectable and hardens at body temperature, forming a stable bone-like structure. In a canine model, the material supported new bone growth similar to traditional autografts. Over 26 weeks, the substitute resorbed completely, leaving behind new bone. The material’s properties were confirmed using imaging and chemical analysis. The findings suggest that this fully resorbable bone substitute could be a promising alternative to autografts in clinical settings.

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Area of Science:

  • Biomaterials in orthopedic surgery
  • Tissue engineering within regenerative medicine
  • Calcium phosphate applications in bone repair

Background:

Current bone grafting techniques rely heavily on autografts, which come with donor site morbidity. Synthetic bone substitutes offer alternatives but often lack resorbability or integration. Prior research has shown that calcium phosphate materials can mimic bone mineral and support osteogenesis. However, the long-term in vivo stability and resorption profiles of such materials remain unclear. No prior work had resolved the full resorption timeline of apatitic calcium phosphate in a large animal model. This gap motivated the development of a fully resorbable calcium phosphate bone substitute. The need for a material that hardens at body temperature and integrates with new bone is well established. The injectability and resorption properties of calcium phosphate have been studied, but not in a fully resorbable formulation. This paper's contribution is the first detailed in vivo evaluation of a novel apatitic calcium phosphate bone substitute.

Purpose Of The Study:

Keywords:
apatitic calcium phosphatebone substituteresorbable graft materialcanine bone repair

Frequently Asked Questions

The study found that the ABS material supports new bone formation and resorbs completely within 26 weeks in a canine model.

The ABS hardens endothermically at 37°C to form a poorly crystalline apatitic calcium phosphate.

The model was selected to mimic clinical bone repair scenarios and evaluate new bone growth and defect filling characteristics.

FTIR and XRD analysis of rabbit intramuscular implants confirmed the stability of the ABS material at 4, 7, and 14 days post-implantation.

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This study aimed to evaluate the in vitro and in vivo properties of a novel, fully resorbable apatitic calcium phosphate bone substitute. The specific problem addressed is the need for a bone graft material that is injectable, hardens at body temperature, and resorbs completely. The motivation stems from limitations in current bone graft options, including donor site complications and incomplete resorption. The ABS was designed to form a poorly crystalline apatitic calcium phosphate upon hydration. The study sought to confirm the material’s stability and resorption rate in vivo. The canine femoral slot defect model was selected to mimic clinical bone repair scenarios. The goal was to compare new bone formation and resorption between ABS and autograft. The study also aimed to track the timeline of defect filling and bone maturation in both groups.

Main Methods:

The ABS was synthesized from calcium phosphate precursors and hydrated to form an injectable paste. The paste hardened endothermically at 37°C to form poorly crystalline apatitic calcium phosphate. Rabbit intramuscular implants were analyzed using FTIR and XRD at 4, 7, and 14 days post-implantation. Canine femoral slot defects were filled with either ABS or autograft. Animals were sacrificed at 3, 4, 12, 26, and 52 weeks for histomorphometric evaluation. Bone formation was assessed using histological and radiographic techniques. The resorption rate of ABS was quantified by measuring residual material in defect sites. The study compared trabecular and cortical bone formation in both groups. The timeline of new bone growth was tracked across multiple time points.

Main Results:

New bone formation in ABS-filled defects progressed similarly to autograft-filled defects. Trabecular bone filled the defect within 3 to 4 weeks in both groups. Lamellar bone formation was evident by week 12 in both conditions. Histomorphometric analysis showed that ABS was greater than 99% resorbed within 26 weeks. At 26 weeks, residual ABS occupied 0.36 ± 0.36% of the original defect area. The resorption rate was consistent across all four specimens analyzed. No significant differences were observed in new bone growth between the two materials. The ABS material maintained stability in vivo as confirmed by FTIR and XRD analysis. The endothermic hardening process at 37°C was effective in forming a stable apatitic calcium phosphate.

Conclusions:

The ABS material demonstrated resorption rates and new bone formation comparable to autograft in a canine model. The material hardened endothermically at body temperature to form a stable apatitic calcium phosphate. The resorption timeline of ABS was greater than 99% within 26 weeks. The study confirmed that ABS supports trabecular and lamellar bone formation. No significant differences were observed in defect filling or bone growth between ABS and autograft. The material’s injectability and in vivo stability were key findings. The authors propose that ABS is a viable alternative to autograft in bone repair. The study supports further clinical evaluation of this fully resorbable bone substitute.

New bone formation was assessed using histological and radiographic techniques across multiple time points.

The authors propose that ABS is a viable alternative to autograft in bone repair due to its resorption rate and bone formation support.