Hydroxyapatite + collagen vs. beta-tricalcium phosphate in bone substitution implantation

Study Type: Therapy
OE Level of Evidence: 2
Journal Level of Evidence: N/A
Synopsis
130 patients undergoing bone substitution implantation were randomized to one of two synthetic porous composite groups for the purpose of comparing the efficacy and safety throughout a 24-week period: (1) porous hydroxyapatite/collagen composite (HAp/CoL) or (2) porous beta-tricalcium phosphate (beta-TCP). Results demonstrated that a significantly larger proportion of patients in the HAp/CoL had "highly effective" implants and regeneration when compared to the beta-TCP group at 18 and 24 weeks. However, the number Please login to view the rest of this report. Please login to view the rest of this report.
Funding: Industry funded
Sponsor: HOYA Technosurgical Company, Contract Development Program of the Japan Sciences and Technology Agency (JST)
Conflicts: Royalties
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Why was this study needed now?
Allogenic and autogenic bone grafts are regularly used in the treatment of large bone defects caused by benign tumours and fractures. However, due to complications such as donor site morbidity and risk of disease transmission, there has been an increased demand for alternative materials that maintain or improve osteogenic capability and mechanical properties. Materials such as sintered calcium phosphate, injectable calcium phosphate, demineralized bone matrix, and mineralized naturally derived polymers have been proposed, but current evidence has yet to determine a definative gold standard. Synthetic hydroxyapatite/collagen composite (HAp/CoL) has been demonstrated to have excellent osteoconductivity and bio-resorbability in basic science and animal research trials; however, its efficacy in human population had yet to be evaluated in a high-quality clinical trial.
What was the principal research question?
For patients undergoing bone substitution implantation treatment for large bone defects, did the use of porous hydroxyapatite/collagen composite (HAp/CoL) provide significantly improved implant success and patient safety when compared to porous beta-tricalcium phosphate (beta-TCP) when assessed over a 24-week period post-surgery?
Population: 130 patients over the age of 20 who required bone substitution implantation were included. Bone defects were required to have an area of less than 30 cm^2 and to have been caused by a benign bone tumor, fracture, or harvesting of a bone autograft.
Intervention: HAp/CoL group: patients were given porous hydroxyapatite/collagen composite (HOYA Technosurgical Co., Tokyo, Japan). Substitute was in a block format (10X10X10 mm or 30X20X10 mm size) with 95% porosity and a macrospore size between 100 to 500 micrometers. Immediately prior to implantation, substitute was wet by either saline or blood from the operative field for softening (n=65, 59 completed follow-up; mean age= 43.2+/-13.4, 31F/28M).
Comparison: Beta-TCP group: patients were given commercially available porous beta-tricalcium phosphate composite (Olympus Co., Tokyo, Japan). Substitute was in a block format (10X10X10 mm or 30X20X10 mm) with 75% porosity and a macropore size between 100 and 400 micrometers and in granular formats (where granule size ranged from 0.1-1.5, 1.0-3.0, 2.3-5.0, and 4.7-8.0 mm) (n=65, 60 completed follow-up; mean age= 43.2+/-14.8, 24F/36M).
Outcomes: Radiographs assessing continuity with surrounding tissue and bone regeneration/remodeling at the implantation were obtained and evaluated by three independent expert raters, where success score was allocated after discussion and majority rule (four-point scale, indicating highly effective, effective, less effective and ineffective). In cases where implantation volume was larger than 10 cm^3, computed tomography images were additionally obtained for scoring reference. Patient blood and urine samples were obtained throughout study period to analyze effects of biodegradable material resorption by osteoclasts.
Methods: RCT: multi-centre, phase-III clinical trial
Time: Outcomes of interest were evaluated perioperatively with follow-up at 2, 4, 8, 12, 18, and 24 postoperative weeks.
What were the important findings?
What should I remember most?
How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.