Lower limb direct skeletal attachment. A Yucatan micropig pilot study.

Regardless of the type of prosthetic lower limb, successful ambulation requires proper prosthetic attachment. To help alleviate many of the problems associated with prosthetic attachment, direct skeletal attachment (DSA) has been proposed as an alternative to conventional sockets. The purpose of the current study was to evaluate the feasibility of lower limb DSA in a micropig model and to develop a systematic approach to the development and analysis of DSA systems. The DSA device consisted of two stages. The load-carrying stage embedded in the bone canal was designed using bone remodeling theory in conjunction with finite element analysis to approximate implant-induced remodeling and stabilization out to 36 months postimplantation. The skin-interfacing stage was designed to maintain an immutable infection barrier where the prosthesis exited the body. Following successful design, fabrication, and benchtop evaluation, the device was surgically implanted in a Yucatan micropig. The animal trial was successful out to 10 weeks and revealed potential flaws in the surgical protocol related to thermal necrosis. However, no signs of infection were present at the time of implant retrieval. While results of this pilot study support the feasibility of a DSA approach to prosthetic limb attachment, additional animal trials are necessary to prove long-term viability.

Distal femoral fixation: a biomechanical comparison of trigen retrograde intramedullary (i.m.) nail, dynamic condylar screw (DCS), and locking compression plate (LCP) condylar plate.

BACKGROUND: The purpose of this study was to establish if there are biomechanical differences between implants in stiffness of construct, microdisplacement, and fatigue failure in a supracondylar femoral fracture model. METHODS: A retrograde intramedullary (i.m.) nail, dynamic condylar screw (DCS), and locked condylar plate (LCP) were tested using 33-cm long synthetic femurs. A standardized supracondylar medial segmental defect was created in the distal femur bone models. A gap away from the distal joint axis and parallel to the knee axis was created for axial testing of the specimens (Arbeitsgemeinschaft fur Osteosynthesefragen [AO] type 33-A) and a T-fracture (33-C) was created for the fatigue testing of the specimens. Peak displacements were measured, and analysis was done to determine construct stiffness and gap micromotion in axial loading. Cyclic loading was performed for fatigue testing. RESULTS: It was observed that there were statistically significant differences in micromotion across the fracture gap and overall stiffness of various implant constructs. The stiffness of the i.m. nail, DCS, and LCP were 1,106, 750, and 625 N/mm, respectively. The average total micromotion across the fracture gap for the i.m. nail, DCS, and LCP were 1.96, 10.55, and 17.74 mm, respectively. In fatigue testing, the i.m. nail distal screws failed at 9,000 cycles, the DCS did not fail (80,000 cycles completed), and the LCP failed at 19,000 and 23,500 cycles. CONCLUSIONS: When considering micromotion and construct stiffness, the i.m. nail had statistically significant higher stiffness and significantly lower micromotion across the fracture gap with axial compression. Hence, the i.m. nail tested had the greatest stability for type 33-A fractures. However, the nail demonstrated the least amount of resistance to fatigue failure with type 33-C fractures, whereas the DCS did not fail with testing in any pattern.

Pullout strength and load to failure properties of self-tapping cortical screws in synthetic and cadaveric environments representative of healthy and osteoporotic bone.

BACKGROUND: The parameters of self-tapping screw (STS) performance in normal and osteoporotic bone have been defined in representative environments, but the question remains as to the clinical application of such findings. The goal of this study was to analyze the biomechanical performance of STSs in cadaveric and synthetic environments representative of healthy and osteoporotic bone. METHODS: Ninety-six Synthes STSs were inserted into cadaveric and synthetic models representative of osteoporotic and healthy bone. Screws were inserted to depths of 1 mm short of the far cortex, flush and 1 mm and 2 mm beyond the far cortex. Screws were tested with an Instron 8511 material testing system utilizing axial pullout forces. A SAS procedure was used to conduct analysis of variance for unbalanced datasets. RESULTS: Substantial differences were appreciated with respect to screw performance between osteoporotic and healthy bone specimens. Although a similar pattern of increased pullout strength and loading energy with increasing depth of insertion was demonstrated, absolute values were lower in osteoporotic specimens. Although performance trends were similar in cadaveric and synthetic testing models for both osteoporotic and healthy bone, values obtained during testing were different. Incomplete insertion of STSs resulted in a 21.5% and 37% reduction of biomechanical properties in osteoporotic and normal bone, respectively. CONCLUSIONS: These results indicate that previously published findings on the performance of STSs in synthetic models cannot reasonably be applied to the clinical realm. Although trends may be similar, screw performance in synthetic, as compared with cadaveric, models is markedly different.

The effect of pilot hole size on the insertion torque and pullout strength of self-tapping cortical bone screws in osteoporotic bone.

BACKGROUND: All surgical screws can experience failure if the torsional, tensile, and flexion loads exerted on the screws are excessively high. The use of self-tapping screws (STS) results in higher insertion torques (IT) as these screws cut their own threads in the pilot hole drilled in the bone. In this study, the torque for inserting the STS into an osteoporotic bone block for different pilot hole sizes (PHS) was measured and the pullout strength (PS) for extraction of the screws was determined for different depths of insertion, 0 mm, 1 mm, and 2 mm beyond the far cortex. METHODS: Seventy-two Synthes stainless steel STS (40 mm length and 3.5 mm diameter) were inserted into pilot holes of sizes 2.55 (A: 73% OD), 2.50 (B: 71.5%), 2.45 (C: 70%), and 2.8 mm (D: 80%). Using a digital torque screwdriver, screws were inserted to 0 mm, 1 mm or 2 mm past the far cortex. Pullout tests were conducted with an Instron materials testing system. Analysis of variance and Student-Neuman-Keuls tests were performed to determine the effect of DOI and PHS on the loading energy, PS, and IT. RESULTS: Results demonstrated that IT of the screws inserted into pilot holes A, B, and C were higher than those in D. It was also observed that PS and loading energy for 1 mm and 2 mm penetration past the far cortex were higher than those for 0 mm regardless of PHS. This study also found that an increase in PHS to 2.8 mm will reduce IT but will also reduce the PS relative to a PHS of 2.5 mm, the current standard for 3.5 mm screws. CONCLUSIONS: The results of previously published studies regarding the effect of pilot hole size on PS in healthy cortical bone cannot be applied to the osteoporotic environment. The findings presented in this research support using PHS no larger than 71.5% of the screw outer diameter (i.e., pilot hole size of 2.5 mm for 3.5 mm screws) and inserting screws at least 2 mm beyond the far cortex to maximize PS and minimize iatrogenic damage in osteoporotic bone.

Experimental evaluation of the holding power/stiffness of the self-tapping bone screws in normal and osteoporotic bone material.

OBJECTIVE: The goal of this study is to compare the holding power of the self-tapping bone screws in normal and osteoporotic bone materials. BACKGROUND: Self-tapping screws are increasingly being used in orthopaedic surgery due to their advantages over the other bone screws. METHODS: Screws were divided into five groups (six screws per group) based on the depth of insertion in the bone coupons that represented normal and osteoporotic bones. Screws were randomly inserted into the bone coupons with tips of the screws being -1 mm, 0 mm, 1 mm, 2 mm and 3 mm relative to the far cortex. Biomechanical testing was performed using an Instron 8,511 in accordance with the American Society for Testing and Materials standards for bone screws. Two-factor analysis of variance (ANOVA) was used to determine if the holding power of the screws were different with respect to insertion depths and bone materials. FINDINGS: The bone materials had a significant difference (P < 0.05) in the holding power and depths of insertion past the far cortex were significantly different from one another in holding power. The affect of the screw material on the holding power of the self-tapping screws in different bone materials was also examined. The performance of stainless steel screws was superior to that of titanium screws in the osteoporotic material. INTERPRETATION: Based on the results it can be concluded that the depth of insertion of the tip of the screw for adequate fracture fixation in normal bone is 1mm or more past the far cortex and in osteoporotic bone it is at least 2mm past the far cortex.

Finite element analysis as a tool for parametric prosthetic foot design and evaluation. Technique development in the solid ankle cushioned heel (SACH) foot.

In this study, we developed an approach for prosthetic foot design incorporating motion analysis, mechanical testing and computer analysis. Using computer modeling and finite element analysis, a three-dimensional (3D), numerical foot model of the solid ankle cushioned heel (SACH) foot was constructed and analyzed based upon loading conditions obtained from the gait analysis of an amputee and validated experimentally using mechanical testing. The model was then used to address effects of viscoelastic heel performance numerically. This is just one example of the type of parametric analysis and design enabled by this approach. More importantly, by incorporating the unique gait characteristics of the amputee, these parametric analyses may lead to prosthetic feet more appropriately representing a particular user's needs, comfort and activity level.