A novel apparatus to assess the mechanical properties of Ankle-Foot Orthoses: Stiffness analysis of the Codivilla spring.

Ankle-Foot Orthoses (AFOs) are the most common devices prescribed to support the ankle and restore a quasi-normal gait pattern in drop-foot patients. AFO stiffness is possibly the main mechanical property affecting foot and ankle biomechanics. A variety of methods to evaluate this property have been reported, however no standard procedure has been validated and widely used. This study is reporting the repeatability of a novel apparatus to measure AFO stiffness in ideal frictionless conditions. The apparatus is based on a servo-hydraulic testing machine and allows to apply a displacement-controlled rotation of the AFO shell, simulating the physiological ankle dorsi/plantarflexion movement. The repeatability of the apparatus in measuring AFO stiffness in dorsiflexion and plantarflexion was assessed intra- and inter-session in a sample of standard polypropylene AFOs of different sizes (Codivilla spring). The repeatability of the apparatus in measuring the AFO stiffness was high. The Intra- and Inter-session Coefficient of Variation ranged between 0.02 ÷ 1.3 % and 1.3 ÷ 5 %, respectively. The Intra Class Correlation Coefficient ranged between 0.999 ÷ 1 intra- and 0.993 ÷ 0.997 inter-session. AFOs stiffness was observed to increase with the AFO size. The setup is easy to replicate and can be implemented with any torsion-controlled servo-hydraulic testing machine and has resulted simple to use and flexible enough to adapt to AFOs with different sizes. The frictionless contacts characterizing the apparatus make it possible to measure the ideal AFO stiffness by excluding the effect of the fixation methods to the leg and help to improve the repeatability of measurements.

Effect of long-term physiological activity on the long-term stem stability of cemented hip arthroplasty: in vitro comparison of three commercial bone cements.

Long-term endurance of the cement mantle is fundamental for the survival of cemented hip prostheses. Current protocols to characterize bone cements are unsuitable to predict the actual clinical outcome. The aim of this study was to assess if it is possible to rank cement types having diverse clinical outcome by using a simplified in vitro physiological test. Composite femurs were implanted with identical stems (Lubinus-SPII), using different commercial cement types: CMW1 to represent cement with poor clinical outcome; Simplex-P and Cemex-RX to represent cements with a positive clinical outcome. Implanted femurs were subjected to a validated protocol that simulated a demanding but physiological loading spectrum. Inducible micromotions and permanent migrations were recorded throughout the test. After test completion, the cement mantles were sectioned and inspected with dye penetrants to quantify the fatigue-induced cracks. Micromotions did not differ significantly between cement types (possibly because a successful prosthesis was chosen that is very stable in the host bone). Significant differences were observed in terms of cement cracks: CMW1 induced significantly more numerous and larger cracks than Simplex-P and Cemex-RX; no difference was observed between Simplex-P and Cemex-RX. This indicates that this protocol: (a) can discriminate between 'good' and 'bad' cements and (b) yields consistent results when comparable cements are tested. The proposed protocol overcomes the limitations of existing standardized material tests for bone cements. New cements can be assessed in comparison with other cements with known (positive/negative) clinical outcome, tested with the same protocol.

Long-term implant-bone fixation of the femoral component in total knee replacement.

Success of total knee replacement (TKR) depends on the prosthetic design. Aseptic loosening of the femoral component is a significant failure mode that has received little attention. Despite the clinical relevance of failures, no protocol is available to test long-term implant-bone fixation of TKR in vitro. The scope of this work was to develop and validate a protocol to assess pre-clinically the fixation of TKR femoral components. An in vitro protocol was designed to apply a simplified but relevant loading profile using a 6-degrees-of-freedom knee simulator for 1,000000 cycles. Implant-bone inducible micromotions and permanent migrations were measured at three locations throughout the test. After test completion, fatigue damage in the cement was quantified. The developed protocol was successfully applied to a commercial TKR. Additional tests were performed to exclude artefacts due to swelling or creep of the composite femur models. The components migrated distally; they tilted towards valgus in the frontal plane and in extension in the sagittal plane. The migration patterns were consistent with clinical roentgen-stereophotogrammetric recordings with TKR. Additional indicators were proposed that could quantify the tendency to loosen/stabilize. The type and amount of damage found in the cement, as well as the migration patterns, were consistent with clinical experience with the specific TKR investigated. The proposed pre-clinical test yielded repeatable results, which were consistent with the clinical literature. Therefore, its relevance and reliability was proved.

Preclinical assessment of the long-term endurance of cemented hip stems. Part 1: effect of daily activities--a comparison of two load histories.

The loads during daily activities contribute to fixation failure of cemented hip stems. In-vitro preclinical testing so far has consisted of simulating one or two conditions. Only a small percentage of hip implants fail, with a higher failure rate in most active patients. The goal was to define a procedure to assess the long-term effect of the lifestyle of a reasonably active patient on implant micromotions. Thus, a cyclic load of constant amplitude is unsuitable. All activities inducing high loads were included, to replicate the most critical scenario in terms of fatigue. The following motor tasks were simulated: stair climbing and descending, car entry and exit, bathtub entry and exit, and stumbling. An in-vitro simulation running for 15 days was able to replicate the load peaks occurring in 24 years of patient activity. Inducible micromotion and permanent migration were monitored. The load history was successfully applied to two different designs with known clinical performance, yielding significantly different micromotions for the two types. Results from the present load history were compared against a simpler profile including only stair climbing. Results showed that the new load profile is more sensitive to differences and can more easily discriminate between different designs. Part 2 of this work describes a further validation against retrieved implants.

Preclinical assessment of the long-term endurance of cemented hip stems. Part 2: in-vitro and ex-vivo fatigue damage of the cement mantle.

Fatigue damage in the cement mantle surrounding hip stems has been studied in the past. However, so far no quantitative method has been validated for assessing ex-vivo damage and for predicting the in-vitro risk of cement fracture. This work presents a method for measuring cement damage; the cement mantle was sliced and sections were inspected with dye penetrants and an optical microscope. Cracks were counted, measured, and classified by type in each region of the cement mantle. Statistical indicators (in total and per unit volume of cement) were proposed that allow quantitative comparison. The method was first validated on two implant types with known clinical success rate, which were tested in vitro using a physiological loading profile (described in Part 1 of this work). The most relevant indicators were able to detect statistical differences between the two designs. Retrieved cement mantles (the same design as one of the in-vitro stems) from revision surgery were also processed with the same inspection method. Excellent qualitative and quantitative agreement was found between the in-vitro generated fatigue damage and the cracking pattern found in the ex-vivo retrieved cement mantles. This demonstrated the effectiveness of the cement inspection protocol and provided a further validation to the in-vitro testing method.