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Objectives

Bioresorbable orthopaedic devices with calcium phosphate (CaP) fillers are commercially available on the assumption that increased calcium (Ca) locally drives new bone formation, but the clinical benefits are unknown. Electron beam (EB) irradiation of polymer devices has been shown to enhance the release of Ca. The aims of this study were to: 1) establish the biological safety of EB surface-modified bioresorbable devices; 2) test the release kinetics of CaP from a polymer device; and 3) establish any subsequent beneficial effects on bone repair in vivo.

Methods

ActivaScrew Interference (Bioretec Ltd, Tampere, Finland) and poly(L-lactide-co-glycolide) (PLGA) orthopaedic screws containing 10 wt% β-tricalcium phosphate (β-TCP) underwent EB treatment. In vitro degradation over 36 weeks was investigated by recording mass loss, pH change, and Ca release. Implant performance was investigated in vivo over 36 weeks using a lapine femoral condyle model. Bone growth and osteoclast activity were assessed by histology and enzyme histochemistry.


The early failure and revision of bimodular primary total hip arthroplasty prostheses requires the identification of the risk factors for material loss and wear at the taper junctions through taper wear analysis. Deviations in taper geometries between revised and pristine modular neck tapers were determined using high resolution tactile measurements. A new algorithm was developed and validated to allow the quantitative analysis of material loss, complementing the standard visual inspection currently used.

The algorithm was applied to a sample of 27 retrievals (in situ from 2.9 to 38.1 months) of the withdrawn Rejuvenate modular prosthesis. The mean wear volumes on the flat distal neck piece taper was 3.35 mm3 (0.55 to 7.57), mainly occurring in a characteristic pattern in areas with high mechanical loading. Wear volume tended to increase with time to revision (r² = 0.423, p = 0.001). Implant and patient specific data (offset, stem size, patient’s mass, age and body mass index) did not correlate with the amount of material loss observed (p >  0.078). Bilaterally revised implants showed higher amounts of combined total material loss and similar wear patterns on both sides. The consistent wear pattern found in this study has not been reported previously, suggesting that the device design and materials are associated with the failure of this prosthesis.

Cite this article: Bone Joint J 2015;97-B:1350–7.