Low wear of a second-generation highly crosslinked polyethylene liner: a 5-year radiostereometric analysis study.

BACKGROUND: A sequentially irradiated and annealed, second-generation highly crosslinked polyethylene (XLPE) liner was introduced clinically in 2005 to reduce in vivo oxidation. This liner design has also been shown to reduce wear in vitro when compared with conventional and first-generation crosslinked liners. To date, there is only one study reporting an in vivo wear rate of this liner at 5 years' followup. However, that study used measurements made from plain radiographs, which have limited sensitivity, particularly when monitoring very low amounts of wear. QUESTIONS/PURPOSES: What is the amount and direction of wear at 5 years using radiostereometric analysis (RSA) in patients who had THAs that included second-generation XLPE? METHODS: We prospectively reviewed 21 patients who underwent primary cementless THA with the same design of XLPE acetabular liner and 32-mm articulation. Tantalum markers were inserted during surgery and all patients had RSA radiographs at 1 week, 6 months, and 1, 2, and 5 years postoperatively. Femoral head penetration within the acetabular component was measured with UmRSA(®) software. One patient died and two had incomplete radiographs leaving 18 radiographic series for analysis. RESULTS: The mean amounts of proximal, two-dimensional, and three-dimensional head penetration between 1 week and 5 years were 0.018, 0.071, and 0.149 mm, respectively. The mean proximal, two-dimensional, and three-dimensional wear rates calculated between 1 year and 5 years were all less than 0.001 mm/year with no patient recording a wear rate of more than 0.040 mm/year. CONCLUSIONS: The head penetration of a second-generation XLPE liner remained low at 5 years and the wear rate calculated after the first year was low in all directions. This low level of wear remains encouraging for the future clinical performance of this material.

Wear of a 5 megarad cross-linked polyethylene liner: a 6-year RSA study.

BACKGROUND: One cross-linked polyethylene (XLPE) liner is manufactured using a lower dose of radiation, 5 Mrad, which may result in less cross-linking. The reported in vivo wear rate of this XLPE liner in patients undergoing THA has varied, and has included some patients in each reported cohort who had greater than 0.1 mm/year of wear, which is an historical threshold for osteolysis. Previous studies have measured wear on plain radiographs, an approach that has limited sensitivity. QUESTIONS/PURPOSES: We therefore measured the amount and direction of wear at 6 years using Radiostereometric analysis (RSA) in patients who had THAs that included a cross-linked polyethylene liner manufactured using 5 Mrad radiation. METHODS: We prospectively reviewed wear in 30 patients who underwent primary THAs with the same design of cross-linked acetabular liner and a 28-mm articulation. Tantalum markers were inserted during surgery and all patients had RSA radiographic examinations at 1 week, 6 months, 1, 2, and 6 years postoperatively. RESULTS: The mean proximal, two-dimensional (2-D) and three-dimensional (3-D) wear rates calculated between 1 year and 6 years were 0.014, 0.014, and 0.018 mm/per year, respectively. The direction of the head penetration recorded between 1 week and 6 years was in a proximal direction for all patients, proximolateral for 16 of 24 patients, and proximomedial for eight of 24 patients. CONCLUSIONS: The proximal, 2-D and 3-D wear of a XLPE liner produced using 5 Mrad of radiation was low but measurable by RSA after 6 years. No patients had proximal 2-D or 3-D wear rates exceeding 0.1 mm/year. Further followup is needed to evaluate the effect of XLPE wear particles on the development of long-term osteolysis.

The 6-year migration characteristics of a hydroxyapatite-coated femoral stem: a radiostereometric analysis study.

A prospective cohort of 30 patients undergoing primary total hip arthroplasty for treatment of osteoarthritis was enrolled in a study to characterize the migration behavior of a clinically successful cementless stem. At 6 years, the mean subsidence of the stem was 0.63 mm (range, -0.33 to 3.68 mm); the mean rotation into retroversion was 1.41° (range, -1.33° to 7.48°). No stems had additional subsidence of more than 0.25 mm between 6 months and 6 years. The resultant mean subsidence between 2 and 6 years was 0.03 mm, which is below the limit measurable by radiostereometric analysis. The data demonstrate that subsidence of this cementless stem occurs within the first 6 months, after which there is persistent stabilization.

Early migration characteristics of a hydroxyapatite-coated femoral stem: an RSA study.

Measurement of early stem subsidence can be used to predict the likelihood of long-term femoral component loosening and clinical failure. Data that examines the early migration pattern of clinically proven stems will provide clinicians with useful baseline data with which to compare new stem designs. This study was performed to evaluate the early migration pattern of a hydroxyapatite-coated press-fit femoral component that has been in use for over ten years. We enrolled 30 patients who underwent THA for osteoarthritis. The median age was 70 years (range, 55-80 years). Patients were clinically assessed using the Harris hip score. Radiostereometric analysis was used to evaluate stem migration at three to four days, six months, one year and two years. We observed a mean subsidence of 0.73 mm at six months, 0.62 mm at one year and 0.58 mm at two years and a mean retroversion of 1.82° at six months, 1.90° at one year and 1.59° at two years. This data suggests that subsidence is confined to the first six months after which there was no further subsidence. The results from this study can be compared with those from novel cementless stem designs to help predict the long-term outcome one may expect from new cementless stem designs.

Two-year migration characteristics of a novel cementless femoral stem: a radiostereometric analysis and clinical outcomes study.

BACKGROUND: Radiostereometric analysis (RSA) is an established high precision tool enabling us to detect early implant migration in total hip arthroplasty. The aim of this study is to present the RSA and clinical results of a new cementless hip stem and to compare those with established benchmarks. METHODS: A total of 45 patients (46 hips) undergoing total hip arthroplasty were available for full radiographic and clinical assessment at 2 years post-operatively. Mean patient age was 69 (range 43-85) years and mean body mass index was 29 (range 21-38) kg/m2 . RSA was undertaken at day 1, 6 weeks, 6 months and 1 and 2 years post-operatively. Oxford hip score and EQ-5D-5L scores were recorded preoperatively and at the same other time points. Results were compared to published data of established implants. RESULTS: At 2 years, mean subsidence and retroversion were 0.61 mm (standard deviation 0.7 mm, range -0.19 to 3.06 mm) and 0.44° (standard deviation 0.81°, range 0.98 to 3.29°), respectively. Stem migration occurred primarily in the first 6 weeks with no detectable subsidence or rotation at 6 months or 2 years. Mean Oxford hip score and EQ-5D-5L improved from 18.6 to 44.7, and 69 to 86, respectively. There was one cup-only revision and no revisions for stem loosening. CONCLUSION: RSA serves as an accurate measure of femoral stem stability early in the post-operative period. Our data confirm that stability occurs as early as 6 weeks and is sustained at 2 years. The Paragon stem demonstrates stability parameters at 2 years that exceed other established benchmark implants.

Second-generation highly cross-linked X3™ polyethylene wear: a preliminary radiostereometric analysis study.

BACKGROUND: First-generation highly cross-linked polyethylene liners have reduced the incidence of wear particle-induced osteolysis. However, failed acetabular liners have shown evidence of surface cracking, mechanical failure, and oxidative damage. This has led to the development of second-generation highly cross-linked polyethylene, which has improved wear and mechanical properties and resistance to oxidation in vitro. Owing to its recent introduction, there are no publications describing its clinical performance. QUESTIONS/PURPOSES: We assessed early clinical wear of a second-generation highly cross-linked polyethylene liner and compared its clinical performance with the published results of hip simulator tests and with first-generation highly cross-linked polyethylene annealed liners. PATIENTS AND METHODS: Twenty-one patients were enrolled in a prospective cohort study. Clinical outcome and femoral head penetration were measured for 19 patients at 6 months and 1 and 2 years postoperatively. RESULTS: The median proximal head penetration was 0.009 mm and 0.024 mm at 1 and 2 years, respectively. The median two-dimensional (2-D) head penetration was 0.083 mm and 0.060 mm at 1 and 2 years, respectively. The median proximal wear rate between 1 and 2 years was 0.015 mm/year. CONCLUSIONS: The wear rate calculated was similar to the in vitro wear rate reported for this material; however, it was less than the detection threshold for this technique. Although longer followup is required for wear to reach a clinically quantifiable level, this low level of wear is encouraging for the future clinical performance of this material. LEVEL OF EVIDENCE: Level IV, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.

Tibial interference screw fixation in anterior cruciate ligament reconstruction with and without autograft bone augmentation.

PURPOSE: Because tibial fixation of soft-tissue grafts in anterior cruciate ligament (ACL) reconstruction is problematic, this study aimed to develop a means of delivering bone graft evenly around tendon autograft and define any mechanical, radiologic, or histologic benefit using an ovine model. METHODS: A device to deliver bone graft evenly throughout the tibial tunnel was developed. Forty mature sheep underwent simulated quadruple hamstring tendon-ACL reconstruction by use of a bioresorbable interference screw, either with or without bone graft augmentation of the tibial tunnel. Endpoint data were derived at time 0 and after 6 weeks in vivo. Radiostereometric analysis provided quantitation of the translational characteristics; computed tomography evaluated tunnel volume, and measures of yield strength and stiffness were obtained. Sequential fluorochrome administration assessed bone formation, and light microscopy surveyed the biological response. RESULTS: Radiostereometric analysis highlighted differences in the translational characteristics of ACL-deficient knees when compared with intact knees. Reconstructed knees (with or without autograft) showed significantly greater translation when compared with unoperated knees at 6 weeks; autograft bone augmentation provided no benefit. Neither tunnel volume nor yield strength nor stiffness was improved with the addition of autograft bone. No untoward histologic responses were observed. Bone apposition rates were similar between treatment groups. An even distribution of bone graft throughout the tunnels was observed. CONCLUSIONS: This model has confirmed the ability of the bone graft-delivery system to evenly distribute bone graft throughout the tunnels. However, the study has failed to show improvement in stability or fixation strength after augmentation with autograft bone. CLINICAL RELEVANCE: The autograft bone-delivery system may provide a means of establishing an osteoconductive/inductive environment. At this early juncture (6 weeks), no benefit could be defined. Its use in combination with bone morphogenetic proteins or stem cells may provide more rapid fixation, rehabilitation, and reconstitution of bone volume within the tunnel.

A Novel Bone Substitute with High Bioactivity, Strength, and Porosity for Repairing Large and Load-Bearing Bone Defects.

Achieving adequate healing in large or load-bearing bone defects is highly challenging even with surgical intervention. The clinical standard of repairing bone defects using autografts or allografts has many drawbacks. A bioactive ceramic scaffold, strontium-hardystonite-gahnite or "Sr-HT-Gahnite" (a multi-component, calcium silicate-based ceramic) is developed, which when 3D-printed combines high strength with outstanding bone regeneration ability. In this study, the performance of purely synthetic, 3D-printed Sr-HT-Gahnite scaffolds is assessed in repairing large and load-bearing bone defects. The scaffolds are implanted into critical-sized segmental defects in sheep tibia for 3 and 12 months, with bone autografts used for comparison. The scaffolds induce substantial bone formation and defect bridging after 12 months, as indicated by X-ray, micro-computed tomography, and histological and biomechanical analyses. Detailed analysis of the bone-scaffold interface using focused ion beam scanning electron microscopy and multiphoton microscopy shows scaffold degradation and maturation of the newly formed bone. In silico modeling of strain energy distribution in the scaffolds reveal the importance of surgical fixation and mechanical loading on long-term bone regeneration. The clinical application of 3D-printed Sr-HT-Gahnite scaffolds as a synthetic bone substitute can potentially improve the repair of challenging bone defects and overcome the limitations of bone graft transplantation.

Qualitative and Quantitative Radiological Measures of Fracture Healing.

The formulation of appropriate postoperative strategies, following fracture repair, currently involves an understanding of radiological and clinical outcome measures. This study has evaluated several modalities used to assess the progression of bone healing in a sheep tibial segmental defect model. Measures of defect optical density and volumetric data including bone density (BD), bone volume (BV) and bone mass (BM) were compared with qualitative data involving visual appraisal of radiographs [% bridging callus and modified radiographic union score tibia (mRUST)] and a clinical outcome measure (locomotory function). Percent bridging callus and mRUST measures displayed strong correlation (r = 0.999), while locomotory function was weakly correlated with bridging callus (r = 0.029) and mRUST (r = 0.046). There was moderate to strong correlation between the qualitative and quantitative data. Bone density, BV and BM showed strong correlations within this dataset (BD-BV, r = 0.814; BD-BM, r = 0.818; BV-BM, r = 1.000). Likewise, optical density measures were strongly correlated with BD (r = 0.824), BV (r = 0.957) and BM (r = 0.959). The utilization of both qualitative and quantitative data, in assessment of the progression of fracture healing, has provided valuable insight. Measures of optical density have been shown to make a substantial contribution to this assessment and which should be considered for use in studies evaluating fracture healing.

Early acetabular cartilage wear following hemiarthroplasty: An ovine model.

OBJECTIVES: Hemiarthroplasty induces degenerative changes in the hip joint, which are difficult to evaluate in vivo. Radiostereometric analysis (RSA) is a radiographic measurement technique that has recently been used to measure acetabular cartilage wear in vivo. The aim of the study was to measure acetabular cartilage wear, using this technique, in an ovine model during the first 14 weeks post-implantation. METHODS: Measurements of three-dimensional femoral head migration, combined with visual assessments at necropsy and safranin O staining for cartilage integrity, were undertaken. RESULTS: Mean femoral head migration during the first six weeks was 0.525 mm in the medial, 0.144 mm in the cranial, and 0.517 mm in the dorsal direction. The majority of this migration was confirmed to be cartilage wear in the medial and dorsal aspects of the acetabulum at necropsy and with subsequent histological evaluation depicting significant cartilage degeneration. CLINICAL SIGNIFICANCE: Radiostereometric analysis is the current gold standard technique for in vivo assessment of implant migration following total hip replacement. This study has utilized RSA to quantify the amount of early cartilage wear in vivo, which was supported by ex vivo evaluations. Accurately measuring the amount of cartilage wear will allow future studies to compare component material and design characteristics prior to clinical use.

The accuracy of three-dimensional reconstructions of the ovine knee: dissectional validation.

A single, complete, ovine knee was imaged using conventional MRI then dissected allowing comprehensive dimensional measurement of the intra-articular structures. A three-dimensional (3-D) computer model of the knee was generated from the MR sections. Thirty-two individual structural measures were recorded from the image output for which there was an available surgical measure for direct comparison. The results of Pearson's correlation testing show a rounded score of 1.00, suggesting an exceptional linear correlation between direct anatomical measurement and the 3-D image output. Further analysis of the data revealed an average error of measurement of 0.2mm across the 32 measures. The findings of this preliminary study suggest that 3-D reconstruction from MR data may be an appropriate, and accurate, means for making dimensional measurements of the bony and soft tissue structures of the ovine knee. It is unlikely that the measurement error would be of any great clinical significance. There is evidence in the literature to suggest that an ovine knee may be considered an acceptable model for substitution for the human knee in diagnostic assessment studies. Therefore, such findings may be considered clinically relevant in the field of human knee assessment.

Preclinical trial of a novel surface architecture for improved primary fixation of cementless orthopaedic implants.

BACKGROUND: A new surface architecture for cementless orthopaedic implants (OsteoAnchor), which incorporates a multitude of tiny anchor features for enhancing primary fixation, was tested in an ovine hemi-arthroplasty pilot study. METHODS: Test animals were implanted with a hip stem component incorporating the OsteoAnchor surface architecture produced using additive layer manufacturing and control animals were implanted with stems containing a standard plasma sprayed titanium coating. FINDINGS: Intra-operative surgeon feedback indicated that superior primary fixation was achieved for the OsteoAnchor stems and rapid return to normal gait and load bearing was observed post-operation. Following a 16-week recovery time, histological evaluation of the excised femurs revealed in-growth of healthy bone into the porous structure of the OsteoAnchor stems. Bone in-growth was not achieved for the plasma sprayed stems. INTERPRETATION: These results indicate the potential for the OsteoAnchor surface architecture to enhance both the initial stability and long term lifetime of cementless orthopaedic implants.

Stem micromotion after femoral impaction grafting using irradiated allograft bone: a time zero in vitro study.

BACKGROUND: A gamma irradiation dose of 15kGy has been shown to adequately sterilise allograft bone, commonly used in femoral impaction bone grafting to treat bone loss at revision hip replacement, without significantly affecting its mechanical properties. The objective of this study was to evaluate whether use of 15kGy irradiated bone affects the initial mechanical stability of the femoral stem prosthesis, as determined by micromotion in a comprehensive testing apparatus, in a clinically relevant time zero in vitro model of revision hip replacement. METHODS: Morselised ovine bone was nonirradiated (control), or irradiated at 15kGy or 60kGy. For each dose, six ovine femurs were implanted with a cemented polished taper stem following femoral impaction bone grafting. Using testing apparatus that reproduces stem loading, stems were cyclically loaded and triaxial micromotion of the stem relative to the bone was measured at the proximal and distal stem regions using non-contact laser transducers and linear variable differential transformers. FINDINGS: There were no significant differences in proximal or distal stem micromotion between groups for all directions (p≤0.80), apart for significantly greater distal stem medial-lateral micromotion in the 60kGy group compared to the 15kGy group (P=0.03), and near-significance in the anterior-posterior direction (P=0.08, power=0.85). INTERPRETATION: Using a clinically relevant model and loading apparatus, irradiation of bone at 15kGy does not affect initial femoral stem stability following femoral impaction bone grafting.

The impact of tensioning device mal-positioning on strand tension during anterior cruciate ligament reconstruction.

BACKGROUND: In order to confer optimal strength and stiffness to the graft in Anterior Cruciate Ligament (ACL) reconstruction, the maintenance of equal strand tension prior to fixation, is desired; positioning of the tensioning device can significantly affect strand tension This study aimed to determine the effect of tensioning device mal-positioning on individual strand tension in simulated cadaveric ACL reconstructions. METHODS: Twenty cadaveric specimens, comprising bovine tibia and tendon harvested from sheep, were used to simulate ACL reconstruction with a looped four-strand tendon graft. A proprietary tensioning device was used to tension the graft during tibial component fixation with graft tension recorded using load cells. The effects of the tensioning device at extreme angles, and in various locking states, was evaluated. RESULTS: Strand tension varied significantly when the tensioning device was held at extreme angles (p < 0.001) or in 'locked' configurations of the tensioning device (p < 0.046). Tendon position also produced significant effects (p < 0.016) on the resultant strand tension. CONCLUSION: An even distribution of tension among individual graft strands is obtained by maintaining the tensioning device in an unlocked state, aligned with the longitudinal axis of the tibial tunnel. If the maintenance of equal strand tension during tibial fixation of grafts is important, close attention must be paid to positioning of the tensioning device in order to optimize the resultant graft tension and, by implication, the strength and stiffness of the graft and ultimately, surgical outcome.

Suture characteristics following incubation in synovial fluid or phosphate buffered saline.

Selection of an appropriate suture requires a knowledge of many factors. These include its mechanical characteristics, its durability, the period of mechanical effectiveness and the tissue reactivity to the material. Absorbable suture materials were incubated in synovial fluid or phosphate buffered saline, at 37 degrees C, for periods up to 12 weeks. Mechanical testing was performed to determine the yield strength, percentage elongation and stiffness of each material in response to incubation. Significant differences were observed in response to time of incubation, material size ('0' or '2-0'), incubation medium and material properties (P < 0.001). Based on the results obtained Vicryl and PDS appear ideal for short-term and medium term apposition, respectively. Panacryl has more durable mechanical features and may well be suited to long-term tissue apposition, such as tendon repair or arthroplasty.

Bone blood flow response to surgical trauma.

The evolution of bone plate design has been with a view to reducing the interface contact between the plate and the underlying bone thereby limiting the perfusion deficiency that develops. Little consequence, however, has been attributed to the drilling of holes in the steps prior to bone plate application; the work present herein attempts to define the vascular response of bone to the trauma of drilling holes. Anaesthetized sheep underwent the creation of drill holes in both tibiae and metatarsi. Animals were then heparinized and euthanatized. Utilizing femoral cannula, perfusion of the vasculature ensued; spalteholz (India ink), disulphine blue and radiocontrast material (barium sulfate). Decalcified histology was performed and correlated with the perfusion studies. Regions of perfusion deficiency were observed immediately adjacent to, and removed from, the drill hole site. Radiographic images showed substantial haematoma formation and vascular disruption in the vicinity of the drill hole site. Histologically, blood vessels immediately adjacent and distal to the drill hole site, contained a proteinaceous/cellular material occluding the vascular space. Our findings support the proposal of a short-term obstruction in cortical blood flow which may contribute to later adaptational osteopaenia following bone plate application. We have observed an acute vascular insufficiency in cortical bone directly related to the trauma of drilling screw holes.

An evaluation of interface contact profiles in two low contact bone plates.

Bone plate design has evolved dramatically in recent years. The Dynamic Compression Plate (DCP) has been superseded by bi- and uni-cortical plates that claim a reduced interface contact between the plate and the underlying bone. It is believed that contact reduction ameliorates the localised ischaemia that develops subsequent to plate application. In this study, the interface characteristics of the Limited Contact-Dynamic Compression Plate (LC-DCP) and the Contour Plus (CP) plating systems have been quantitated using Fuji prescale pressure sensitive film interposed between the plate and the bone. Ten-hole plates were applied to the same aspect of either the humeral, radial or ulnar diaphysis of human cadaveric bone in a reproducible manner. The average pressure, force and interface contact area were calculated using Interactive Data Language (IDL) image analysis software. The CP system was consistently lower, in terms of interface contact, than the LC-DCP in each of the specimen locations tested (P<0.0001). The CP system displayed a 'point-contact' configuration along the interface with high pressures recorded at these points, the significance of which is unknown.

Ultimate tensile strength of a Leeds-Keio/autograft ACL reconstruction utilizing PLLA tibial staple fixation.

An ovine model of anterior cruciate ligament reconstruction was utilized to evaluate the biomechanical and histological response of a polylactic acid tibial fixation staple (Gunze Ltd., Japan/Zimmer, Japan). This was performed in a comparison with metallic staples, currently utilized for this procedure. The prosthesis consisted of autograft combined with a Leeds-Keio (L-K) ligament. Early post-operative mobilization was followed by retrieval of specimens at 6, 12 and 24 weeks post-reconstruction. Evaluation of the mechanical characteristics of the graft reconstructions (tensile strength) showed no significant differences (P>0.05) between the staple types for each time period. The histological response to the polylactic acid staple was minimal over the time period studied, with no adverse tissue reactions observed. The mode of reconstruction failure was observed to change with time (P<0.05) presumably as the graft characteristics alter. Overall the absorbable staples performed at a comparable level with the metallic staples within the scope of the study.