Cup In Total Hip Arthroplasty Research Articles

Intraoperative measurement of cup inclination using fluoroscopy requires a correction factor.

Malpositioning of the cup in total hip arthroplasty (THA) is associated with dislocation, early polyethylene wear, and impingement. The direct anterior approach (DAA) THA allows for intraoperative fluoroscopy imaging (IF). The current study investigates the following research hypotheses: (1) intraoperative measurements of radiographic cup inclination (RI) are reliable and reproducible. (2) A correction factor can compensate for the complex parallax effects when using IF. In 2016, 100 consecutive hips underwent primary THA utilizing DAA and IF for cup placement. RI was measured on intraoperative fluoroscopy images and postoperative AP pelvis radiographs. Determination of RI on IF images is reliable and reproducible (ICC 0.851-0.950). RI measurement on IF images had a good correlation with the corresponding postoperative RI on AP pelvis radiographs (r = 0.538, p < 0.001). However, intraoperative RI measurements are on average 4.9° lower compared to postoperative measurements (SD 2.5°). Intraoperative fluoroscopy is a reliable tool to measure RI during DAA THA. The surgeon needs to apply a 5°. correction factor to the intraoperative measurements to adjust for parallax.

Dual mobility cups in total hip arthroplasty after failed internal fixation of proximal femoral fractures

IntroductionPerforming total hip arthroplasty (THA) following failed internal fixation of proximal femur fractures is associated with an elevated risk of implant dislocation. We hypothesized that using a dual mobility (DM) cup will help to reduce the risk of postoperative instability in this specific context. Material and methodsThis was a retrospective study of 33 consecutive patients who underwent DM THA following failed internal fixation of a proximal femur fracture. The clinical assessment consisted of the Postel-Merle d’Aubigné and HHS scores along with an analysis of preoperative and follow-up radiographs. The primary outcome was the occurrence of implant dislocation. ResultsAt the last follow-up (44±24 months), 7 patients had died and 0 were lost to follow-up. Only one dislocation had occurred (3%). The mean PMA and HSS scores of 14.8 and 80 respectively were significantly better than the preoperative scores. There were no cases of aseptic loosening. ConclusionThe use of DM cups in the context of THA following failed internal fixation of proximal femur fractures helps to reduce the risk of dislocation. Thus DM cups are recommended in this indication with high risk of postoperative instability.

30-Years of experience with the cementless implanted Alloclassic CSF screw cup total hip arthroplasty system – An ultra-long-term follow-up

ObjectiveThe aim of this study was to evaluate our long-term results with the Alloclassic CSF screw cup total hip arthroplasty system. This is the first study to provide a 30-year follow-up, based upon our 30-year follow up study on the Alloclassic stem system. MethodsWe reviewed 178 Alloclassic CSF screw cup systems, implanted in 171 patients from 1986 to 1987. The Zweymüller stem family was used in all cases. 136 patients had died over the last 30 years, so twenty-nine out of 35 patients being still alive, with a mean follow-up of 29,46 years (SD 0,48), were contacted by telephone and evaluated radiologically and clinically. Our loss-to-follow up was 17,14%. The mean age at follow-up was 83,01 years (72,4–95,2; SD 6,86). ResultsIf the endpoint is defined as the removal of the cup for aseptic loosening (3 cases), the overall survival rate is 98,31%. If the endpoint is revision for any reason (27 cases), the survival rate is 84,83%. Eleven patients needed an exchange of head and liner. The mean time from implantation until change of head and liner was 21,44 years (SD 5,92). ConclusionAfter 30 years of monitoring we can state that the evaluated system is very reliable in primary and secondary THA.

To cement or not to cement acetabular cups in total hip arthroplasty: a systematic review and re-evaluation.

Introduction: Total Hip Arthroplasty (THA) in the treatment of primary osteoarthritis of the hip has evolved to a very safe and cost-effective intervention with revision rates below 5% after 10 years. To this day, however, controversy remains on whether or not to cement the acetabular cup. Methods: A comprehensive PubMed search of the English literature for studies published between 2007 and 2018 was performed. Studies comparing the clinical (revision rate, functionality), radiological (wear) or economic (cost) differences between cemented (cemented stem with cemented cup) and hybrid (cemented stem with uncemented cup) prostheses for primary osteoarthritis of the hip were identified as eligible. Results: A total of 1032 studies were identified whereof twelve were included for qualitative synthesis. All studies concerning the risk of revision were based on registry data, covering a total of 365,693 cups. Cemented prostheses had a similar or lower risk of revision compared to hybrid prostheses in every study, but performed slightly worse on functionality and quality of life. While cemented prostheses were the cheapest option, hybrids were the most cost-effective. Discussion: The widespread preference for cementless fixation of the acetabulum cannot be explained by a superior survival of cementless or hybrid models. Irrespective of age, cemented fixation of the acetabulum remains the gold standard to which other techniques should be compared.

Bone density measurements adjacent to acetabular cups in total hip arthroplasty using dual-energy CT: an in vivo reliability and agreement study.

BackgroundMeasuring bone mineral density (BMD) around acetabular prosthetic components with computed tomography (CT) is challenged by the complex anatomy and metal artifacts. Three-dimensional (3D) segmentation is required for the analysis, but it is usually not practically applicable on current CT workstationsPurposeTo test the between-scan agreement and reliability of custom segmentation software for BMD measurements adjacent to cemented and uncemented acetabular cups in dual-energy CT (DECT).Material and MethodsTwenty-four male patients with total hip arthroplasty were scanned and rescanned using 130-keV virtual monochromatic DECT images. Hemispherical regions of interest were defined slice-by-slice and BMD was calculated around the acetabular cup using custom segmentation software.ResultsIn the uncemented cup, the mean BMD was 153 mg/cm3 with a between-scan difference of 10 mg/cm3 (P < 0.0001). In the cemented cup, the mean BMD was 186 mg/cm3 with a between-scan difference of 6 mg/cm3 (P = 0.15). In both uncemented and cemented cups the intraclass correlation coefficient between repeated measurements was >0.95 and narrow Bland–Altman Limits of Agreement.ConclusionBMD can be measured with high absolute between-scan agreement and good reliability adjacent to acetabular cemented and uncemented cups using DECT and segmentation software.

THAにおけるPinnacle Porocoat cupの短期成績

THAにおけるPinnacle Porocoat cupの短期成績

Some biomechanical features of medialization of the pressed and screwed-in cups in total hip arthroplasty in patients with dysplastic coxarthrosis

After total joint replacement in patients with dysplastic coxarthrosis, a significant number of negative results are observed. One of the ways of solving the problem of primary stability of the endoprosthetic cup is its mediation by deepening the acetabulum in the zone of its a natomical center.Objective: top erform a comparative biomechanical evaluation of the stability of the cups that are fastened and screwed up, in the event of their mediation performed under the conditions of joint replacement in patients with dysplastic coxarthrosis.Methods: with the help of mathematical modeling, the relatively strong characteristics of the pelvic bone in the area of the acetabulum and the quality of fixation of cup and cup after their mediation and immersion in the zone of the anatomical center of the depression. The total displacement of the head of the femoral component of the implant is analyzed.Results: it was found that using scintillating cup under the condition of dysplastic coxarthrosis provides total displacement in (2.2 ÷ 2.4) times greater than in the situations of its application without defect of the acetabulum. When the cup is pressed, the total displacement is 4.7 times larger than the screw cup. In these cases, hip replacement with the use of pressed cups is accompanied by a high risk of their primary instability.Conclusions: the use of screw-in cups in the case of their mediation under the conditions of total joint replacement in patients with dysplastic coxarthrosis provides a more reliable primary stability than the ones pushed into cups. The level of tension in the pelvic bone of the acetabulum is influenced by the depth of the cup setting, with the increase of which there is a significant destruction of bone tissue. It is advisable to carry out the hip joint replacement in the case of dysplastic coxarthrosis using a screw-in cup.

Efficacy of a computed tomography-based navigation system for placement of the acetabular component in total hip arthroplasty for developmental dysplasia of the hip.

Developmental dysplasia of the hip (DDH) presents a considerable surgical challenge in total hip arthroplasty (THA). Although the usefulness of computed tomography (CT)-based navigation in cup alignment has been reported, few reports have evaluated three-dimensional (3-D) cup positioning against the acetabulum specifically in patients with DDH. The purpose of this study was to evaluate the efficacy of a CT-based navigation system for alignment and spatial positioning of the cup in THA for patients with DDH. We reviewed 174 DDH THA cases in which CT-based navigation was used, and 75 cases in which a mechanical guide was used as a control group. Postoperative cup alignment and spatial positioning were evaluated by superimposition of a 3-D cup template onto the actual implanted cup using postoperative CT images, with pelvic coordinates matching the preoperative planning. The proportion within the combined target zone (inclination and anteversion) was 97.7% in the navigation group and 61.3% in the non-navigation group. The mean absolute error between the intraoperative record and the postoperative measurement was 1.5° ± 1.3° for inclination and 2.1° ± 1.8° for anteversion in the navigation group. For acetabular cup positioning, the mean discrepancy between the preoperative planning and the postoperative measurements was 1.9 ± 1.6 mm on the transverse axis, 2.8 ± 2.3 mm on the longitudinal axis, and 1.7 ± 1.3 mm on the sagittal axis. THA using a CT-based navigation system achieved quite high accuracy of cup alignment angles and spatial cup positioning in primary THA for patients with DDH.

Precision and accuracy of imageless navigation versus freehand implantation of total hip arthroplasty: A systematic review and meta-analysis.

Total hip arthroplasty (THA) is named the most successful surgical procedure of the twentieth century. To remain a success in the twenty-first century THA should meet the higher demands of patients and society with regard to technical and functional outcome, costs and implant survival. To meet these demands optimal acetabular cup positioning is necessary. An imageless navigation system (NAV) might prevent malpositioning of the acetabular cup in THA. The aim of this study has been to compare the precision and accuracy of the anteversion and inclination of the acetabular cup position after NAV implantation and after freehand implantation of THA. A systematic review and meta-analysis was conducted to assess the precision (variance) and accuracy (deviation from the target) from all available high-quality randomised control trials to date. Six out of seven studies concluded a statistically significant difference in precision in anteversion between the NAV group and the freehand group. Five out of seven studies concluded a statistically significant difference in precision in inclination. There is a significantly better accuracy for the NAV group than for the freehand group for anteversion (p=0.002) and for inclination (p=0.01). This study showed that NAV placement is more precise and has an improved accuracy for anteversion and inclination than freehand placement of the acetabular cup. However, there is a lack of evidence to support an improved functional outcome and a reduction of complications and revisions.

Effect of Jumbo cups for total hip arthroplasty revision on femoral offset and hip center of rotation

To investigate the change of the femoral offset and hip center of rotation (COR) after using Jumbo cups in total hip arthroplasty (THA) revision. The clinical data of 23 patients who underwent THA revision using Jumbo cups between January 2010 and May 2015 were retrospectively analyzed. Morselized bone graft was performed on 8 cases, morselized bone graft combined with structural bone graft on 10 cases. There were 10 males and 13 females, aged 65.4 years on average (range, 51-77 years). The disease duration was 1-24 years (mean, 8.57 years). The reasons for revision included aseptic loosening in 21 cases and periprosthetic infection in 2 cases. The Harris hip score and visual analogue scale (VAS) were 43.04±5.05 and 5.70±0.97 before operation respectively. According to the Paprosky acetabular defect classification, there were 5 cases of type I, 5 cases of type II A, 3 cases of type II B, 6 cases of type II C, and 4 cases of type III A. The X-ray films showed that the femoral offset was (40.65±4.09) mm for normal side and was (44.04±5.08) mm for affected side at preoperation, showing significant difference ( t=4.098, P=0.000). Ten patients underwent femoral offset reconstruction (43.48%) but 13 patients did not (56.52%) before operation. The COR was reconstructed in 10 cases (43.48%); COR elevation was observed in 11 cases (47.83%), and COR decline in 2 cases (8.69%) before operation. Primary healing of incision was obtained in all patients, with no complication of infection, vascular injury, deep vein thrombosis, dislocation of the joint, or fracture around prosthesis. All the patients were followed up 12-76 months (mean, 22.48 months). The Harris hip score and VAS were 82.09±4.53 and 0.74±0.62 at 1 year after operation respectively, showing significant differences when compared with preoperative scores ( t=37.831, P=0.000; t=22.318, P=0.000). The X-ray films showed that the femoral offset was (43.87±3.57) mm for affected side at 1 year after operation, showing no significant difference when compared with preoperative one ( t=0.250, P=0.805), but significant difference was found between affected side and normal side ( t=5.591, P=0.000). The femoral offset was restored in 16 patients (69.57%) and was not restored in 7 patients (30.43%) after operation. The COR was restored in 15 patients (65.22%) and was not restored in 8 patients (34.78%). Using Jumbo cups or combined with morselized or structural bone graft is effective in restoring hip COR and femoral offset at the maximum limit in THA revision, with good short-term outcome and improved stability of acetabular prosthesis.

Increase in safe zone area of the acetabular cup using dual mobility cups in THA.

Dual mobility cup (DMC) inserts reduce the risk of dislocation after total hip arthroplasty (THA). No available research has clearly delineated stability advantages of DMC inserts in primary and revision THA. We investigated: (i) the degree of change in the safe zone of the cup when a DMC insert is used compared to a fixed insert; (ii) the method of selecting candidates for a DMC insert without changing the position of the acetabular (cup) component during revision THA in frequent dislocation cases caused by implant impingement. A model of the pelvis and femur was developed from computed tomography images. The safe zone was defined as the area in the acetabular component, over which conditions for stable range of motion were satisfied. The safe zone was calculated for both a fixed and a DMC insert over a predetermined range of 3-D motion, and the effect of increasing the anteversion position of the femoral component from 5° to 35° was quantified. The lowest ratio of the area of the safe zone was about 4.9 at 20° anteverison of the femoral component. Safe zone of DMC inserts zone had increased stability of 10°-15° in both vertical and horizontal directions, compared to fixed inserts.A 5- to10-fold expansion of the safe zone can be expected with the use of DMC insert. DMC insert could help to set the acetabular component more accurately in primary and revision THA.

Segmental acetabular rim defects, bone loss, oversizing, and press fit cup in total hip arthroplasty evaluated with a probabilistic finite element analysis.

Management of segmental rim defects and bone mineral density (BMD) loss in the elderly prior to total hip replacement is unclear within classification systems for acetabular bone loss. In this study, our objectives were (1) to understand how a reduction in BMD in the elderly affects the oversizing of a press-fit cup for primary fixation and (2) to evaluate whether the location of the segmental defect affected cup fixation. A finite element (FE) model was used to simulate and evaluate cup insertion and fixation in the context of segmental rim defects. We focused on the distribution of patients over age 70 and used BMD (estimated from CT) as a proxy for aging's implications on THR and used probabilistic FE analysis to understand how BMD loss affects oversizing of a press-fit cup. A cup oversized by 1.10 ± 0.28mm provides sufficient fixation and lower stresses at the cup-bone interface for elderly patients. Defects in the anterior column and posterior column both required the same mean insertion force for cup seating of 84% (taken as an average of 2 anterior column and 2 posterior column defects) compared to the control configuration, which was 5% greater than the insertion force for a superior rim defect and 12% greater than the insertion force for an inferior rim defect. A defect along the superior or inferior rim had a minimal effect on cup fixation, while a defect in the columns created cup instability and increased stress at the defect location.

Total hip arthroplasty using a cementless dual-mobility cup provides increased stability and favorable gait parameters at five years follow-up

BackgroundRates of dislocation following primary total hip arthroplasty (THA) vary from 0.5 to 10%. Dual-mobility cups in THA demonstrate increased stability. Clinical outcomes following THA with dual-mobility cups have been reported, but gait has not been assessed. Therefore we performed a retrospective case control study to answer: (1) is gait better in patients following THA with a dual-mobility cup than in frail, elderly patients of the same age? (2) Are clinical outcomes better in patients following THA with a dual-mobility cup than in frail, elderly patients? (3) What is the dislocation rate following THA with a dual-mobility cup? HypothesisWe hypothesized that patients who underwent THA with a dual-mobility cup have a better gait compared to frail, elderly patients of the same age. Patients and methodsTwenty patients (22 hips), mean age 79.9±7.7 (range, 62.3–88.3) years were assessed in this retrospective case-control series 5.6±1.4 (range: 4.1–8.8) years following dual-mobility cup THA. A reference group consisted of 72 “frail elderly” patients in a rehabilitation hospital for health problems unrelated to the lower limb, with no lower limb surgery or neurological conditions. Temporal and spatial gait performance were measured with four miniature gyroscopes, mounted on each thigh and calf, while patients walked freely along a 30m corridor. Harris Hip Score, WOMAC, radiological outcomes, and dislocation rate were determined. ResultsAll gait parameters were better in the dual-mobility group compared to the frail elderly group. The dual-mobility group had a higher cadence (100.3 steps/minute versus 75.6 steps/minute), shorter (relative to gait cycle time) stance (61.6% versus 67.8%), shorter (relative to gait cycle time) double stance (23.3% versus 36.0%), longer stride (1.13m versus 0.80m), and faster walking speed (0.96m/s versus 0.52m/s). Range of motion of the shank, thigh and knee were better in the dual-mobility group. Harris Hip Score was 87.6±13.9 (range 51–100) and WOMAC score was 11.3±12.1 (range 0–34) in the THA group. We observed no dislocations. DiscussionGait patterns five years following THA with the dual-mobility cup were better or comparable to published study populations. Level of evidenceIII, retrospective case-control series.

Assessment of Accuracy and Reliability in Acetabular Cup Placement Using an iPhone/iPad System.

Implant positioning is one of the critical factors that influences postoperative outcome of total hip arthroplasty (THA). Malpositioning of the implant may lead to an increased risk of postoperative complications such as prosthetic impingement, dislocation, restricted range of motion, polyethylene wear, and loosening. In 2012, the intraoperative use of smartphone technology in THA for improved accuracy of acetabular cup placement was reported. The purpose of this study was to examine the accuracy of an iPhone/iPad-guided technique in positioning the acetabular cup in THA compared with the reference values obtained from the image-free navigation system in a cadaveric experiment. Five hips of 5 embalmed whole-body cadavers were used in the study. Seven orthopedic surgeons (4 residents and 3 senior hip surgeons) participated in the study. All of the surgeons examined each of the 5 hips 3 times. The target angle was 38°/19° for operative inclination/anteversion angles, which corresponded to radiographic inclination/anteversion angles of 40°/15°. The simultaneous assessment using the navigation system showed mean±SD radiographic alignment angles of 39.4°±2.6° and 16.4°±2.6° for inclination and anteversion, respectively. Assessment of cup positioning based on Lewinnek's safe zone criteria showed all of the procedures (n=105) achieved acceptable alignment within the safe zone. A comparison of the performances by resident and senior hip surgeons showed no significant difference between the groups (P=.74 for inclination and P=.81 for anteversion). The iPhone/iPad technique examined in this study could achieve acceptable performance in determining cup alignment in THA regardless of the surgeon's expertise. [Orthopedics. 2016; 39(4):e621-e626.].

Migration and head penetration of Vitamin-E diffused cemented polyethylene cup compared to standard cemented cup in total hip arthroplasty: study protocol for a randomised, double-blind, controlled trial (E1 HIP)

IntroductionIn vitro, Vitamin-E-diffused, highly cross-linked polyethylene (PE) has been shown to have superior wear resistance and improved mechanical properties when compared to those of standard highly cross-linked PE liners used...

The dual mobility cup: what problems does it solve?

Dual mobility cups have two points of articulation, one between the shell and the polyethylene (external bearing) and one between the polyethylene and the femoral head (internal bearing). Movement occurs at the inner bearing; the outer bearing only moves at extremes of movement. Dislocation after total hip arthroplasty (THA) is a cause of much morbidity and its treatment has significant cost implications. Dual mobility cups provide an increased range of movement and a may reduce the risk of dislocation. This paper reviews the use of these cups in THA, particularly where stability is an issue. Dual mobility cups may be of benefit in primary THA in patients at a high risk of dislocation, such as those who are older with increased comorbidities and a higher American Association of Anesthesiology grade and those with a neuromuscular disease. They may be used at revision surgery where the risk of dislocation is high, such as in patients with many prior dislocations, or those with abductor deficiency. They may also be used in THA for displaced fractures of the femoral neck, which has a notoriously high rate of dislocation.

Quantitative Biomedical Imaging: Techniques and Clinical Applications.

Quantitative Biomedical Imaging: Techniques and Clinical Applications.

Dual mobility cup for prevention of early total hip arthroplasty dislocation in patients with neurological disorders

Patients with neurologic disorders are at a higher risk for hip arthroplasty dislocation. This can be attributed to hip muscle weakness, especially the abductor group. We inquired into the use of dual mobility acetabular component for the prevention of early hip dislocation in these patients. Thirty patients with documented neurological disorders and muscle weakness affecting the operated side underwent dual mobility total hip arthroplasty in the period between December 2012 and January 2014. The neurological disorders were cerebrovascular stroke, weakness due to brain tumors, Parkinsonism, old poliomyelitis, and multiple sclerosis. Twelve cases underwent primary dual mobility cup total hip arthroplasty as a treatment for proximal femoral fractures. Eighteen patients were revision to dual mobility total hip arthroplasty either due to failure of proximal femoral fracture fixation or failure of previous arthroplasty. All patients were ambulant (assisted walking) before the primary incident (either surgery or trauma). All patients were operated upon through the lateral approach. All the cups used were cemented. The mean age group of the patients was 64.6 years old. No definite postoperative infection occurred. The mean follow-up period was 13.2 months. One case died 6 months postoperative due to another cerebrovascular stroke. Functionally, all our patients could ambulate (assisted walking) postoperatively. No dislocation was recorded during the follow-up period. The dual mobility cup is effective in the prevention of early dislocation in patients with muscle weakness due to neurological disorders. Long-term follow-up is needed for the assessment of late dislocation, as well as the rate of loosening in this group of patients.

Increased migration of uncemented acetabular cups in female total hip arthroplasty patients with low systemic bone mineral density

Background and purpose — Low bone mineral density (BMD) may jeopardize the initial component stability and delay osseointegration of uncemented acetabular cups in total hip arthroplasty (THA). We measured the migration of uncemented cups in women with low or normal BMD.Patients and methods — We used radiostereometric analysis (RSA) to measure the migration of hydroxyapatite-coated titanium alloy cups with alumina-on-alumina bearings in THA of 34 female patients with a median age of 64 (41–78) years. 10 patients had normal BMD and 24 patients had low systemic BMD (T-score ≤ −1) based on dual-energy X-ray absorptiometry (DXA). Cup migration was followed with RSA for 2 years. Radiographic follow-up was done at a median of 8 (2–10) years.Results — Patients with normal BMD did not show a statistically significant cup migration after the settling period of 3 months, while patients with low BMD had a continuous proximal migration between 3 and 12 months (p = 0.03). These differences in cup migration persisted at 24 months. Based on the perceived risk of cup revision, 14 of the 24 cases were “at risk” (proximal translation of 0.2 to 1.0 mm) in the low-BMD group and 2 of the10 cases were “at risk” in the normal-BMD group (odds ratio (OR) = 8.0, 95% CI: 1.3–48). The radiographic follow-up showed no radiolucent lines or osteolysis. 2 cups have been revised for fractures of the ceramic bearings, but none for loosening.Interpretation — Low BMD contributed to cup migration beyond the settling period of 3 months, but the migrating cups appeared to osseointegrate eventually.

Intra-prosthetic dislocation of dual-mobility cups after total hip arthroplasty: potential causes from a clinical and biomechanical perspective.

Recurrent dislocation of total hip arthroplasty is a frequent indication for revision surgery. Hip joint stability depends on implant design, cup position and crucially on femoral head diameter. Due to an effective ultra-large diameter femoral head, dual-mobility cups are considered an attractive solution to prevent dislocation in unstable conditions. Although patients obviously benefit for many years in terms of mobility and pain, an increase of intra-prosthetic dislocation reports using dual-mobility cups has been recently observed. However, the failure mechanism of this implant-specific complication, which is characterized by the loss of the positive-locking between the femoral head and the mobile liner, is not yet completely understood. A comprehensive search was performed with the PubMed database and a search engine to overview this topic and to identify potential causes for this implant-specific failure from a clinical and biomechanical perspective. Peri-operative findings indicate extensive fibrosis at the large articulation as well as cup loosening as potential causes. In addition, current research has shown that the failure mechanism is affected by the surface topography of the femoral neck and in particular by the design of the mobile liner. In clinical practice it is necessary to differentiate a classic dislocation between the mobile liner and the metallic shell from an intra-prosthetic dislocation between the femoral head and the liner. Due to the increasing popularity of dual-mobility cups in total hip arthroplasty, the understanding of which implant-specific features or tissue response may increase the risk of intra-prosthetic dislocation is of major importance for reduced revision rates by using optimized surgical techniques and implant designs.