Michael M. Morlock

Duration and frequency of every day activities in total hip patients.

Little knowledge about frequency and duration of daily activities in patients after total hip arthroplasty is available. Such information is required for the definition of realistic load collectives for pre-clinical testing of prostheses. It could also be helpful for the quantitative evaluation of surgery outcome with different prosthesis types. The purpose of this study was to develop and apply a system for the determination of frequency and duration of patient activities in their habitual environment and to compare the results to a clinical outcome score (Harris hip score).A portable activity monitoring system (weight 1.6 kg including batteries) was designed using a Palm top computer, 2 inclination sensors for the thigh and calf and one goniometer positioned at the knee joint. An algorithm was developed to identify frequency and duration of the activities lying, sitting, standing, walking and stair climbing from the signals of the 3 sensors. 42 patients participated in the study and were equipped with the system in the morning at their home. Datasets of 31 patients (age 62.5+/-11.5 y) covered more than 6h (9.8 +/- 1.6 h) and were included in the analysis. Prosthesis specific data as well as the Harris hip score were collected. The most frequent patient activity was sitting (44.3% of the time), followed by standing (24.5%), walking (10.2%), lying (5.8%) and stair climbing (0.4%). The median number of steps/stairs was 6048/164. The number of step cycles representing one year in vivo use should, consequently, be increased to 1.1 million. The Harris hip score (91.4 +/- 9.8) correlated significantly with the number of stairs (r(2) = 0.26, p = 0.003) and showed a positive tendency with the number of steps per day. No differences in activity levels between prosthesis specific factors were found.

Modes of implant failure after hip resurfacing: morphological and wear analysis of 267 retrieval specimens.

BACKGROUND Resurfacing of the hip joint is experiencing a revival due to improvements in materials, design, and manufacturing techniques. Despite good midterm outcomes, the high early rate of failure and concerns about metal debris require a detailed morphological and wear analysis of retrieved resurfacing implants in order to understand failure mechanisms. METHODS A worldwide collection of hip resurfacing revision devices was initiated, and 267 components were received. Devices were analyzed by patient demographics, radiographic positioning, and wear, as well as morphologically and histologically. Specimens were grouped into four different failure types. They were also stratified into rim-loaded or non-rim-loaded groups. Failures were also assessed by surgeon learning-curve effects. RESULTS Time to failure was significantly different between the four revision-type groups: Specimens with fractures involving the implant rim were most common (46%) and failed earliest after surgery (mean of ninety-nine days), followed by fractures inside the femoral head (20%, 262 days) and loose cups (9%, 423 days). Revisions not due to fractures or cup loosening (25%) occurred at a mean of 722 days after surgery. Rim-loaded implants exhibited an average twenty-one to twenty-sevenfold higher wear rate than implants without rim-loading. Rim-loaded implants also showed a steeper mean cup inclination than their non-rim-loaded counterparts (59 degrees compared with 50 degrees ). Most failures occurred during the learning curve of the surgeon (the first fifty to 100 implantations). CONCLUSIONS Failures on the femoral side usually occur within the first nine months after surgery and appear to be most directly related to the implantation technique or patient selection. Later failures are observed mainly due to acetabular problems, either due to dramatically increased wear or poor cup anchorage. Improper cup anteversion may be similar to or more important than cup inclination in producing excessive wear.

Corroded Nitinol Wires in Explanted Aortic Endografts: An Important Mechanism of Failure?

Purpose: To analyze surface alterations and fractures observed in the nitinol stent wires of explanted endovascular grafts used for treatment of abdominal aortic aneurysm. Methods: Twenty-one explanted Stentor devices and 1 Cragg stent were received from investigators in Germany and France. After macroscopy and photography, the explants were cleaned and the polyester coating removed. The frame was examined completely by stereomicroscopy, and irregularities were assayed by scanning electron microscopy and energy dispersive x-ray analysis (EDAX). The observed alterations were classified according to stereomicroscopic and electron microscopic morphology. Results: The mean implantation interval for the endografts was 29.1 ± 13.2 months (range 5–46). All examined explants, even those retrieved after only a few months in situ, showed pitlike surface damage 10–25 µm in diameter. Larger, irregularly shaped surface alterations were observed in ∼70% of the explants. Older explants (age >32 months) presented vast regions of decay, with bending of the wire and stress cracks in some areas. EDAX examination revealed decreased nickel concentration in the corroded regions. Conclusions: Corrosion of the nitinol wire in endovascular grafts is confirmed. Presumably, the observed pitting and irregularly shaped corrosion defects are the precursors of material failure. They weaken the thin wire, which leads to stress cracks and eventually fracture of the stent wire under circulatory pulsation. Cell-induced electrochemical corrosion and active cellular destruction of surfaces are well-known mechanisms that must be investigated for their possible roles in the corrosion of stent metals.

Realistic loads for testing hip implants

The aim here was to define realistic load conditions for hip implants, based on in vivo contact force measurements, and to see whether current ISO standards indeed simulate real loads. The load scenarios obtained are based on in vivo hip contact forces measured in 4 patients during different activities and on activity records from 31 patients. The load scenarios can be adapted to various test purposes by applying average or high peak loads, high-impact activities or additional low-impact activities, and by simulating normal or very active patients. The most strenuous activities are walking (average peak forces 1800 N, high peak forces 3900 N), going up stairs (average peak forces 1900 N, high peak forces 4200 N) and stumbling (high peak forces 11,000 N). Torsional moments are 50% higher for going up stairs than for walking. Ten million loading cycles simulate an implantation time of 3.9 years in active patients. The in vitro fatigue properties of cementless implant fixations are exceeded during stumbling. At least for heavyweight and very active subjects, the real load conditions are more critical than those defined by the ISO standards for fatigue tests.

Long-term in vivo alterations of polyester vascular grafts in humans.

OBJECTIVES To examine the influence of in vivo hydrolysis on the physical properties of polyester grafts and their correlation to the period of implantation in the human body. MATERIALS AND METHODS Sixty-five explanted vascular grafts were obtained after 0-23 years of implantation due to suture aneurysms (18), occlusion (12), graft infection (12), failure of graft material (7) and post-mortem (16). The surface was examined by scanning electron microscopy, the molecular integrity by infra-red spectroscopy and physical strength by probe puncture. RESULTS Scission of macromolecular chains and loss of strength were shown. It was demonstrated that hydrolytic degradation of polyester takes place with increasing time of implantation in humans. Analysis by linear regression showed that polyester grafts lose 31.4% of their bursting strength in 10 years and 100% in 25-39 years after implantation. CONCLUSIONS Regular follow-ups of patients with aged vascular grafts and the precise documentation of implanted materials are necessary to estimate graft degradation.

Improvements in vertebral body strength under teriparatide treatment assessed in vivo by finite element analysis: results from the EUROFORS study.

Monitoring of osteoporosis therapy based solely on DXA is insufficient to assess antifracture efficacy. Estimating bone strength as a variable closely linked to fracture risk is therefore of importance. Finite element (FE) analysis–based strength measures were used to monitor a teriparatide therapy and the associated effects on whole bone and local fracture risk. In 44 postmenopausal women with established osteoporosis participating in the EUROFORS study, FE models based on high‐resolution CT (HRCT) of T12 were evaluated after 0, 6, 12, and 24 mo of teriparatide treatment (20 μg/d). FE‐based strength and stiffness calculations for three different load cases (compression, bending, and combined compression and bending) were compared with volumetric BMD (vBMD) and apparent bone volume fraction (app. BV/TV), as well as DXA‐based areal BMD of the lumbar spine. Local damage of the bone tissue was also modeled. Highly significant improvements in all analyzed variables as early as 6 mo after starting teriparatide were found. After 24 mo, bone strength in compression was increased by 28.1 ± 4.7% (SE), in bending by 28.3 ± 4.9%, whereas app. BV/TV was increased by 54.7 ± 8.8%, vBMD by 19.1 ± 4.0%, and areal BMD of L1–L4 by 10.2 ± 1.2%. When comparing standardized increases, FE changes were significantly larger than those of densitometry and not significantly different from app. BV/TV. The size of regions at high risk for local failure was significantly reduced under teriparatide treatment. Treatment with teriparatide leads to bone strength increases for different loading conditions of close to 30%. FE is a suitable tool for monitoring bone anabolic treatment in groups or individual patients and offers additional information about local failure modes. FE variables showed a higher standardized response to changes than BMD measurements, but further studies are needed to show that the higher response represents a more accurate estimate of treatment‐induced fracture risk reduction.

European multidisciplinary consensus statement on the use and monitoring of metal-on-metal bearings for total hip replacement and hip resurfacing.

INTRODUCTION There is an ongoing debate about the optimal use of metal-on-metal (MoM) bearings in total hip replacement, since there are uncertainties about local and systemic adverse effects due to wear and corrosion of these bearings. Despite various national recommendations, efforts to achieve international harmonization of specific evidence-based recommendations for best practice are still lacking. HYPOTHESIS An international consensus study group should be able to develop recommendations on the use and monitoring of MoM bearings, preferably at the European level, through a multidisciplinary approach, by integrating the perspectives of various stakeholders. MATERIALS AND METHODS Twenty-one experts representing three stakeholder groups and eight countries participated in this European consensus study, which consisted of a consensus meeting, subsequent structured discussion, and consensus voting. RESULTS The current statement defines first of all benefits, local and systemic risks, as well as uncertain issues related to MoM bearings. Safety assessment after implantation of MoM comprises all patients. A closer follow-up is recommended for large head MoM (≥36mm) and resurfacing. In these implants basic follow-up should consist of x-rays and metal ion measurement of cobalt in whole blood, performed with GF-AAS or ICP-MS. Clinical and/or radiographic abnormality as well as elevated ion levels needs additional imaging (ultrasound, CT-scan and/or MARS-MRI). Cobalt values less than 2 μg/L are probably devoid of clinical concern, the threshold value for clinical concern is expected to be within the range of 2-7 μg/L. DISCUSSION This is the first multinational, interdisciplinary, and multiprofessional approach for developing a recommendation for the use and monitoring of MoM bearings in total hip replacement. The current recommendations are in partial agreement with previous statements regarding the extent of follow-up and imaging techniques. They however differ from previous communications regarding measurement of metal ions and especially the investigated medium, technique, and eventual threshold levels. LEVEL OF EVIDENCE Level V, expert opinion/agreement conference.

Influence of material coupling and assembly condition on the magnitude of micromotion at the stem-neck interface of a modular hip endoprosthesis

Hip prostheses with a modular neck exhibit, compared to monobloc prostheses, an additional interface which bears the risk of fretting as well as corrosion. Failures at the neck adapter of modular prostheses have been observed for a number of different designs. It has been speculated that micromotions at the stem-neck interface were responsible for these implant failures. The purpose of this study was to investigate the influence of material combinations and assembly conditions on the magnitude of micromotions at the stem-neck interface during cyclic loading. Modular (n = 24) and monobloc (n = 3) hip prostheses of a similar design (Metha, Aesculap AG, Tuttlingen, Germany) were subjected to mechanical testing according to ISO 7206-4 (F(min) = 230N, F(max) = 2300N, f = 1Hz, n = 10,000 cycles). The neck adapters (Ti-6Al-4V or Co-Cr29-Mo alloy) were assembled with a clean or contaminated interface. The micromotion between stem and neck adapter was calculated at five reference points based on the measurements of the three eddy current sensors. The largest micromotions were observed at the lateral edge of the stem-neck taper connection, which is in accordance with the crack location of clinically failed prostheses. Titanium neck adapters showed significantly larger micromotions than cobalt-chromium neck adapters (p = 0.005). Contaminated interfaces also exhibited significantly larger micromotions (p < 0.001). Since excessive micromotions at the stem-neck interface might be involved in the process of implant failure, special care should be taken to clean the interface prior to assembly and titanium neck adapters with titanium stems should generally be used with caution.

Influence of assembly procedure and material combination on the strength of the taper connection at the head-neck junction of modular hip endoprostheses

BACKGROUND A stable fixation between femoral head and endoprosthesis taper is necessary to prevent relative motions and corrosion at the taper junction. Although the importance of the component assembly has been recognised, no definitive instructions are available. The purpose of this study was to assess the influence of assembly force, assembly tool and number of hammer strokes on the taper junction strength of various material combinations. METHODS Co-Cr29-Mo (n=10) and Ti-6Al-4V (n=10) neck tapers were assembled with Co-Cr and Al(2)O(3) ceramic heads either by push-on or by impaction with single or multiple hammer blows. The strength of the taper-head connection was evaluated by measuring the head pull-off forces according to ISO 7206-10 and the turn-off moment capacity. FINDINGS The taper strength linearly increased with assembly forces (P<0.001). Co-Cr heads combined with Co-Cr tapers showed significantly lower pull-off forces and turn-off moments than the combination with Ti tapers (0.001<P<0.025). Multiple impaction did not increase taper strength (0.063 <P<0.995). Ceramic and Co-Cr heads showed similar fixation patterns on Ti tapers. Turn-off moments varied between 6 Nm and 19 Nm, dependent on material combination and assembly force. INTERPRETATION It is suggested that sufficient head-taper junction strength in all bearing conditions is achieved by impaction forces of at least 4 kN. A single impact is sufficient to achieve fixation. Special attention should be paid to the assembly of Co-Cr heads on Co-Cr tapers.

Deformation of press-fitted metallic resurfacing cups. Part 1: Experimental simulation:

Abstract The interference press fit of a metallic one-piece acetabular cup employed for metal-on-metal hip resurfacing procedures was investigated experimentally under laboratory conditions in the present study, in particular regarding the cup deformation. Tests were carried out in cadavers as well as polyurethane foams of various grades with different elastic moduli to represent different cancellous bone qualities. The cadaver test was used to establish the most suitable configuration of the foam model representing realistic support and geometrical conditions at the pelvis. It was found that a spherical cavity, with two identical areas relieved on opposite sides, was capable of creating a two-point pinching action of the ischeal and ilial columns on the cup as the worst-case scenario. Furthermore, the cup deformation produced from such a two-point loading model with a grade 30 foam was similar to that measured from the cadaver test. Therefore, such a protocol was employed in subsequent experimental tests. For a given size of the outside diameter of the cup of 60 mm, the cup deflection was shown to be dependent largely on the cup wall thickness and the diametral interference between cup and prepared cavity at implantation. For a relatively thin cup with a wall thickness between 2.3 mm (equator) and 4 mm (pole) and with a modest nominal diametral interference of 1 mm, which corresponds to an actual interference of approximately 0.5 mm, the maximum diametral cup deflection (at the rim) was around 60 μm, compared with a diametral clearance of 80-120 μm between the femoral head and the acetabular cup, generally required for fluid-film lubrication and tribological performances. Stiffening of the cup, by both thickening and lateralizing by 1 mm, reduced the cup deformation to between 30 and 50 μm with actual diametral interferences between 0.5 and 1 mm.