In total hip arthroplasty (THA), cementless cup without screw holes has the putative benefits of maximizing host bone contact and reducing osteolysis by eliminating channels to backside wear particles. However, supplemental trans-acetabular screws cannot be used. 74 hips in 60 patients receiving same model of cementless cup without screw holes (Depuy Duraloc 100 HA cup) from 6/1999 to 3/2003 were prospectively followed up. All patients were allowed to have immediate full weight bearing. Age at THA was 53 ± 13 (range 24–74) years. Osteonecrosis was the leading hip disease (45% of hips). Survivorship was assessed using revision of the cup as the end point. Radiological parameters, including lateral opening angle, vertical and horizontal migration distances of the cups were measured. Paired t-test was used to compare between the measurements in early postoperative period and at final follow up. 51 hips were assessed at minimum 20 years follow-up. The mean follow-up was 22.6 (range 21 – 25) years. All the cups were well fixed. There were two cup revisions. Conventional polyethylene (PE) was used in both hips; osteolysis occurred 17 and 18 years later. Both cups were well fixed but were revised, one due to cup mal-positioning, one due to need in upsizing the articulation. 14 other hips were revised but these cups were well fixed and not revised; 9 loosened stems (most were cemented Elite plus stems), 5 PE wear and osteolysis (all were conventional PE). At 20 years, the survivorship of cups was 96.1%. Changes in lateral opening angle, vertical and horizontal migration distances were 0.44±1.59°, 0.01±1.52mm and -0.32±1.47mm respectively, without statistical significance. This study provided evidence of excellent long-term survivorship of cementless cup without screw holes. Immediate postoperative weight-bearing also did not lead to cup migration in the long-term

In 2022, approximately 60% of inserted cups and stems in Sweden utilized cemented fixation. Two predominant brands, Refobacin Bone Cement R and Palacos R+G, both incorporating gentamicin, were employed in over 90% of primary cemented Total Hip Arthroplasties (THAs) between 2012 and 2022. This study investigates whether the choice between these cement types affects the risk of revision. The five most frequently used cemented cups and the three most common stems were studied. Inclusion criteria encompassed hips with non-tumour diagnoses, operated through a direct lateral or posterior incision, featuring a 28–36 mm metal or ceramic head. Outcomes were assessed for cup revisions (n=55,457 Refobacin, 37,210 Palacos), stem revisions (n=51,732 Refobacin, 30,018 Palacos), and all-cemented THAs with either brand (n=45,265 Refobacin, 26,347 Palacos). Kaplan-Meier life tables and hazard ratios (HR) utilizing Cox regression were computed, adjusting for age, sex, diagnosis, implant type, femoral head size, and material. Over a 10-year period, the cumulative percent revision with Refobacin was consistently higher than Palacos in all three analyses (cups: Refobacin 2.4 (2.3–2.5), Palacos 2.1 (2.0–2.2); stems: Refobacin 2.6 (2.5–2.7), Palacos 2.1 (2,0–2,2); all-cemented: Refobacin 3.2 (2.9–3.5), Palacos 2.9 (2.6–3.2)). Both unadjusted and adjusted HR were 13–25% lower with Palacos. In the analysis of all-cemented THAs, the adjusted HR for Palacos was 0.85 (0.76–0.95). Separating revisions into infectious and non-infectious reasons revealed a lower risk of infectious revisions with Palacos in all three analyses (all-cemented: adjusted HR infection 0.66 (0.56–0.78); non-infectious 1.10 (0.94–1.28)). Hips cemented with Refobacin may face an increased risk of infection, potentially due to a smaller release of antibiotics into surrounding tissues. Unaccounted factors like different mixing systems or unknown biases could also influence outcomes, emphasizing the need for further investigation

There remains concern with the use of constrained liners (CL) implanted at the time of acetabular cup revision in revision total hip replacement (rTHA). The aim of this study was to determine the implant survival in rTHA when a CL was implanted at the same time as acetabular cup revision. We reviewed our institutional database to identify all consecutive rTHAs where a CL was implanted simultaneously at the time acetabular cup revision from 2001 to 2021. One-hundred and seventy-four revisions (173 patients) were included in the study. Mean follow-up of 8.7 years (range two – 21.7). The most common indications for rTHA were instability (35%), second-stage periprosthetic joint infection (26.4%), and aseptic loosening (17.2%). Kaplan Meier Analysis was used to determine survival with all-cause re-revision and revision for cup aseptic loosening (fixation failure) as the endpoints. A total of 32 (18.3%) patients underwent re-revision at a mean time of 2.9 years (range 0.1 – 14.1). The most common reasons for re-revision were instability (14), periprosthetic joint infection (seven), and loosening of the femoral component (four). Three (1.7%) required re-revision due to aseptic loosening of the acetabular component (fixation failure) at a mean of two years (0.1 – 5.1). Acetabular component survival free from re-revision due to aseptic loosening was 98.9% (95% CI 97.3 – 100) at five-years and 98.1% (95% CI 95.8 – 100) at 10-years. There were no acetabular component fixation failures in modern highly porous shells. CLs implanted at the time acetabular cup revision in rTHA have a 98.1% 10-year survival free from acetabular cup aseptic loosening (fixation failure). There were no cup fixation failures in modern highly porous shells. Thus, when necessary, implanting a CL during revision of an acetabular component with stable screw fixation is safe with an extremely low risk of cup fixation failure

Aims

Dislocation remains a leading cause of failure following revision total hip arthroplasty (THA). While dual-mobility (DM) bearings have been shown to mitigate this risk, options are limited when retaining or implanting an uncemented shell without modular DM options. In these circumstances, a monoblock DM cup, designed for cementing, can be cemented into an uncemented acetabular shell. The goal of this study was to describe the implant survival, complications, and radiological outcomes of this construct.

Dislocation post THA confers a higher risk of re-dislocation (Kotwal et al, 2009). The dual mobility (DM) cup design (1974) was aimed at improving the stability by increasing the femoral head to neck ratio (Cuthbert et al., 2019) combining the ideas of low friction arthroplasty with increased jump distance associated with a big head arthroplasty. Understand the dislocation rates, rates of aseptic loosening, infection rate and revision rates between the 2 types of constructs to provide current and up-to date evidence. Medline, pubmed, embase and Cochrane databases were used based on PRISMA guidelines. RevMan software was used for the meta-analysis. Studies (English literature) which used DM construct with atleast 6 months follow-up used as intervention and non DM construct as control were included. 2 independent reviewers conducted the review with a third reviewer in case of difference in opinion regarding eligibility. Primary outcome was dislocation rate and secondary outcome was rate of revision. 564 articles identified out of which 44 articles were screened for full texts and eventually 4 systematic review articles found eligible for the study. Thus, study became a review of systematic reviews. From the 4 systematic reviews, another 35 studies were identified for data extraction and 13 papers were used for meta-analysis. Systematic reviews evaluated, projected an average follow up of 6-8 years with significantly lower dislocation rates for DM cups. The total number of patients undergoing DM cup primary THA were 30,559 with an average age 71 years while the control group consisted of 218,834 patients with an average age of 69 years. DM group had lower rate of dislocation (p < 0.00001), total lower rate of cup revision (p < 0.00001, higher incidence of fracture (p>0.05). DM THA is a viable alternative for conventional THA. The long-term results of DM cups in primary THA need to be further evaluated using high quality prospective studies and RCTs

Abstract. Introduction. Dislocation post THA confers a higher risk of re-dislocation (Kotwal et al, 2009). The dual mobility (DM) cup design (1974) was aimed at improving the stability by increasing the femoral head to neck ratio (Cuthbert et al., 2019) combining the ideas of low friction arthroplasty with increased jump distance associated with a big head arthroplasty. Aims. Understand the dislocation rates, rates of aseptic loosening, infection rate and revision rates between the 2 types of constructs to provide current and up-to date evidence. Methods. Medline, pubmed, embase and Cochrane databases were used based on PRISMA guidelines. RevMan software was used for the meta-analysis. Studies (English literature) which used DM construct with atleast 6 months follow-up used as intervention and non DM construct as control were included. 2 independent reviewers conducted the review with a third reviewer in case of difference in opinion regarding eligibility. Primary outcome was dislocation rate and secondary outcome was rate of revision. Results. 564 articles identified out of which 44 articles were screened for full texts and eventually 4 systematic review articles found eligible for the study. Thus, study became a review of systematic reviews. From the 4 systematic reviews, another 35 studies were identified for data extraction and 13 papers were used for meta-analysis. Systematic reviews evaluated, projected an average follow up of 6–8 years with significantly lower dislocation rates for DM cups. The total number of patients undergoing DM cup primary THA were 30,559 with an average age 71 years while the control group consisted of 218,834 patients with an average age of 69 years. DM group had lower rate of dislocation (p < 0.00001), total lower rate of cup revision (p < 0.00001, higher incidence of fracture (p>0.05). Conclusion. DM THA is a viable alternative for conventional THA. The long-term results of DM cups in primary THA need to be further evaluated using high quality prospective studies and RCTs. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project

Aims

A revision for periprosthetic joint infection (PJI) in total hip arthroplasty (THA) has a major effect on the patient’s quality of life, including walking capacity. The objective of this case control study was to investigate the histological and ultrastructural changes to the gluteus medius tendon (GMED) in patients revised due to a PJI, and to compare it with revision THAs without infection performed using the same lateral approach.

The August 2023 Hip & Pelvis Roundup³⁶⁰ looks at: Using machine learning to predict venous thromboembolism and major bleeding events following total joint arthroplasty; Antibiotic length in revision total hip arthroplasty; Preoperative colonization and worse outcomes; Short stem cemented total hip arthroplasty; What are the outcomes of one- versus two-stage revisions in the UK?; To cement or not to cement? The best approach in hemiarthroplasty; Similar re-revisions in cemented and cementless femoral revisions for periprosthetic femoral fractures in total hip arthroplasty; Are hip precautions still needed?

Dual mobility (DM) components are increasingly used to prevent and treat dislocation after total hip arthroplasty (THA). Intraprosthetic dissociation (IPD) is a known rare complication of these implants and has reportedly decreased with modern implants. The purpose of this paper is to report the diagnosis and treatment of modern DM IPD. 1453 DM components were implanted between 2010 and 2021. 695 in primary and 758 in revision THA. 49 hips sustained a dislocation of the large head and 5 sustained an IPD at presentation. 6 additional IPD occurred at the time of reduction of large head. The average age was 64, 54% were female and the mean follow-up was three years. Of the 11 IPD, 8 had a history of instability, 5 had abductor insufficiency, 4 had prior lumbar fusion, and 3 were conversions from fracture. The overall IPD incidence was 0.76%. Ten of the 11 DM IPD were missed at initial presentation or at the time of reduction, and all were discharged with presumed reduction. The mean time from IPD to surgical treatment was 3 weeks. One patient died with an IPD at 5 months. A DM head was reimplanted in six, two underwent revision of the acetabular component with exchange of DM head, and four were revised to a constrained liner. The re-revision rate was 55% at a mean 1.8 years. None of the patients who underwent cup revision required subsequent re-revision while half of the constrained liners and exchange of DM heads required re-revision. The overall rate of DM dislocation or IPD is low. It is critical to identify an IPD on radiographs as it was almost universally missed at presentation or when it occurred iatrogenically. For patients presenting with IPD, the surgeon should consider acetabular revision and conversion to a constrained liner or a larger DM, with special attention to removing impinging structures that could increase the risk of re-dislocation

Pelvic tilt can vary over time due to aging and the possible appearance of sagittal spine disorders. Cup position in total hip arthroplasty (THA) can be influenced due to these changes. We assessed the evolution of pelvic tilt and cup position after THA and the possible appearance of complications for a minimum follow-up of ten years. 343 patients received a THA between 2006 and 2009. All were diagnosed with primary osteoarthritis and their mean age was 63.3 years (range, 56 to 80). 168 were women and 175 men. 250 had no significant lumbar pathology, 76 had significant lumbar pathology and 16 had lumbar fusion. Radiological analysis included sacro-femoral-pubic (SFP), acetabular abduction (AA) and anteversion cup (AV) angles. Measurements were done pre-operatively and at 6 weeks, and at five and ten years post-operatively. Three measurements were recorded and the mean obtained at all intervals. All radiographs were evaluated by the same author, who was not involved in the surgery. There were nine dislocations: six were solved with closed reduction, and three required cup revision. All the mean angles changed over time; the SFP angle from 59.2º to 60º (p=0.249), the AA angle from 44.5º to 46.8º (p=0.218), and the AV angle from 14.7º to 16.2º (p=0.002). The SFP angle was lower in older patients at all intervals (p<0.001). The SFP angle changed from 63.8 to 60.4º in women and from 59.4º to 59.3º in men, from 58.6º to 59.6º (p=0.012). The SFP angle changed from 62.7º to 60.9º in patients without lumbar pathology, from 58.6º to 57.4º in patients with lumbar pathology, and from 57.0º to 56.4º in patients with a lumbar fusion (p=0.919). The SFP cup angle was higher in patients without lumbar pathology than in the other groups (p<0.001), however, it changed more than in patients with lumbar pathology or fusion at ten years after THA (p=0.04). Posterior pelvic tilt changed with aging, influencing the cup position in patients after a THA. Changes due to lumbar pathology could influence the appearance of complications long-term

Aims

Iliopsoas impingement occurs in 4% to 30% of patients after undergoing total hip arthroplasty (THA). Despite a relatively high incidence, there are few attempts at modelling impingement between the iliopsoas and acetabular component, and no attempts at modelling this in a representative cohort of subjects. The purpose of this study was to develop a novel computational model for quantifying the impingement between the iliopsoas and acetabular component and validate its utility in a case-controlled investigation.

Background. A few patients undergoing a total hip replacement need a subsequent revision of the cup. In some of these cases, the treating surgeon may be confronted with Unexpected Positive Intraoperative Cultures (UPIC). The exact incidence of this finding is unclear. Moreover, it is unknown what the clinical outcome of these patients is when the stem is left in situ. The aim of our study was to describe the incidence of UPIC in patients undergoing cup revision and to determine the need for total revision in this patient group during follow-up. Methods/design. In this retrospective multicenter cohort study, we included all consecutive patients that underwent a cup revision between 2015–2017 and had a minimal follow-up of 2 years. Patients were divided in 3 cohorts: i) no positive intra operative cultures; ii) one UPIC; iii) two or more UPIC. Cases in whom 2 or fewer cultures were obtained during cup revision were excluded from the analysis. Results. From the 334 evaluated cases, 77 were excluded because an inadequate number of cultures were obtained. From the total of 257 included cases, the incidence of UPIC was 16% (n=39). 21 cases had one (8%), and 18 cases had two or more UPIC (7%). After two years of follow up, implant survival in the no UPIC group was 88% (95% CI 0.83 – 0.93), in the one UPIC group 95% (95% CI 0.86 – 1.0), and in the two or more UPIC group 77% (95% CI 0.57 – 0.97). Survival analysis showed no statistically significant differences between the cohorts as determined by cox regressive analysis and log rank test (P = 0.19). Conclusion. The incidence of UPIC in patients who undergo cup revision is relatively high but does not seem to have a major influence on the need for total revision of the hip during a follow-up of 2 years

With the approval of our institute, we reviewed all the robot-assisted hip revision during October 2019 and August 2021. MAKO joint arthroplasty system was used to perform the hip revision surgery. Seventy-one robot-assisted hip revision cases were included. Cup revisions were carried out in 68 patients while stem revisions were also carried out in 68 patients. Three types of registration techniques (extra acetabular bone surface based, liner based, metal shell based or cage surface based) on the acetabular side. The extra acetabular bone surface was the commonest used for registration (48/70, 68.6%, mean accuracy 0.37mm), followed by liner surface (11/70, 15.7%, mean accuracy 0.36mm), acetabulum cup (10/70, 14.3%, mean accuracy 0.37mm), and cage surface (1/70, 1.4%, accuracy 0.40mm). We succeeded cup registration and robotic arm guided cup insertion in all the cases. The average cup inclination and anteversion after revision were 40.87°±4.39° and 13.87°±4.24°, respectively. Cups in 62 cases (62/68, 91.2%) were within the Lewinnek safe zone while in 55 cases (55/68, 80.9%) were within the Callanan safe zone. The Mako robot-assisted system could bring favorable cup reconstruction in hip revision with acceptable surgical time and blood loss. Accurate registration could be achieved by different methods

To compare complications, survivorship and results in 2 groups of Furlong-HAP Active, one with ceramic-ceramic and the other with metal-XLPE friction pair. Prospective, non-randomized, comparison of 2 series of JRI uncemented prosthesis, implanted with identical protocol by 1 surgeon in 1 hospital from 2006 to 2014. Friction pair was ceramic (Biolox Forte or Delta) in 35 patients of 53.7+/−10.6 years (25–69) (21 males, 60%), and CrCo-XLPE in 65 cases of 69.0+/−8.9 years (42–81) (36 males, 55%); there were significant differences in age (p<0.00001) but not in sex (p=0.6565). Head diameter: Ce-Ce with 19 of 28mm, 9 of 32 and 7 of 36mm; Me-PE with 63 of 28mm, 1 of 32 and 1 of 36. Follow-up averaged 10.5+/−3.1 years (1–15) in ceramic and 9.8+/−3.8 years (2–15) in XLPE group. Pearson, Fisher, Kolmogorov-Smirnov, Student, Mann-Whitney, calculated with the informatic tools Microsoft Excel 2007 and . https://www.socscistatistics.com/tests/. . Complications in ceramic joints: 2 late infections (Fisher exact test=0.6101) (1 DAIR, 1 one-stage exchange); 1 dislocation (Fisher exact test=0.2549) (closed reduction); 1 Vancouver C fracture (ORIF) (Fisher exact test=0.6548). Complications in Me-XLPE joints: 2 late infections (Fisher=0.6101) (1 DAIR, 1 two-stage exchange); 7 dislocations (Fisher=0.2549) (2 early, open reduction) (5 late: 3 closed reduction, 1 cup revision, 1 constrained cup); 4 Vancouver B fractures (Fisher=0.6548) (2 intraoperative, cerclages; 2 late, exchange). Final follow-up: Harris Hip Score averaged 93.2+/−13.7 (23–100) in ceramic and 94.3+/−8.7 (65–100) in XLPE joints (p=0.64552). Wear: 0.06+/−0.38mm (0–1.5) in ceramic and 0.16+/−0.5mm (0–2) in Me-PE THAs (p=0.30302). Osteolysis in Charnley-De Lee zones: 8 zones (6 patients) (17%) in ceramic cups, 25 zones (15 patients) (23%) in XLPE cups (p=0.980127). Survivorship without any surgery or closed reduction after 15 years: 91.0% in ceramic joints, 83.8% in Me-XLPE joints. Survivorship without component exchange after 15 years: 93.9% in ceramic joints, 93.6% in Me-XLPE joints. At least after 10 years follow-up of Furlong-HAP Active, metal-XLPE and ceramic-ceramic joints present no significant differences in complications, clinical score, wear, acetabular osteolysis, or survivorship without component exchange. On the contrary, survivorship without any surgery or closed reduction is different because of the high rate of dislocation in 28mm metal-poly joints

The goal of the study was to describe the features of the aseptic loosening of the cup in CoC THR and to determine factors that affect the time to revision. It is a retrospective study including all patients who had a revision of CoC THR for aseptic failure fixation of the cup, between 2007 and 2017. 55 patients (27 women, 28 men) (56 hips) were included in the study. Eight hips (13 %) had also a stem exchange. At the primary T HR, the mean age of the patients was 47.9 years (17–72), 28 press fit cups had screws, the mean diameter of the cup was 51.2 mm (46–62) and the mean inclination was 52° (37–67). Clinical and radiological data were retrospectively recorded by an observer different to the initial operators. The mean age of the patients at the revision was 55.4 years (26–84). The mean time to revision was 90.1 months (14–240), and was significantly greater in patients aged less than 52 years, in cups without screws and with a 28mm head. The trend curve of the time to cup revision showed a bimodal distribution at three and ten years. 20 cups had migrated (33%). Bone loss was rated type 1 in 41 hips (73.0%), type 2 in 12 hips and type 3 in three hips). The mean diameter of the new cup was 52.3 mm (46–64). It was inferior to that of the initial cup in 26 hips (46.4%). 31 cups were impacted (55.5%) and 25 needed to be cemented (45.5%). No macroscopic wear was detected on the ceramic implant. Aseptic loosening of the cup in CoC THA does not appear to increase over time, supporting the fact that the failure is unrelated to wear and is not due to a biological mechanism. The occurrence of two peaks of frequency over time may suggest that different mechanisms occur

The increasing number of total hip arthroplasty (THA) used in young patients will inevitably lead to more revision procedures at younger ages, especially since the outcome of primary THA in young patients is already inferior compared to older patients. However, these data are lacking in literature. The aim of this study was to determine the survival of both acetabular and femoral components placed during primary and revision hip arthroplasty in patients under 55 years using Dutch Arthroplasty Register (LROI) data. All primary THA registered in the LROI between 2007–2018 in patients under 55 years were selected (n=25,682). Subsequent cup- and stem revision procedures were included. Kaplan-Meier survival analyses were used to estimate the survival probability of primary and revised cup- and stem components. Mean follow-up of primary cups and stems was 5.8 years (SD 3.2) and 5.9 years (SD 3.2), respectively. In total, 659 cup revision procedures and 532 stem revision procedures were registered. Most common reason for cup revision was acetabular loosening (n=163), most common reason for stem revision was femoral loosening (n=202). Primary cup survival for any reason at 10 years follow-up was 96.1% (95%CI: 95.7–96.4). For primary stems, 10 year survival for any reason was 97.1% (95%CI: 96.7–97.3). Mean follow-up of all revision procedures was 4.1 years (SD 2.9). Out of 659 cup revisions, 113 cup re-revisions were registered. Survival of revised cups, with end-point cup re-revision for any reason was 82.2% (95%CI: 78.8–85.1) at 5 years follow-up. Out of 532 stem revisions, 89 stem re-revisions were registered. For revised stems, survival at 5 year follow-up, with endpoint stem re-revision for any reason was 82.0% (95%CI: 78.2–85.2). The outcome of revised acetabular and femoral components is worrisome, with a survival of 82% at 5 years follow-up. This information is valuable to provide realistic expectations for these young patients at time of primary THA

Aims

Modular dual mobility (MDM) acetabular components are often used with the aim of reducing the risk of dislocation in revision total hip arthroplasty (THA). There is, however, little information in the literature about its use in this context. The aim of this study, therefore, was to evaluate the outcomes in a cohort of patients in whom MDM components were used at revision THA, with a mean follow-up of more than five years.

Aims

“Get It Right First Time” (GIRFT) and NHS England’s Best Practice Tariff (BPT) have published directives advising that patients over the ages of 65 (GIRFT) and 69 years (BPT) receiving total hip arthroplasty (THA) should receive cemented implants and have brought in financial penalties if this policy is not observed. Despite this, worldwide, uncemented component use has increased, a situation described as a ‘paradox’. GIRFT and BPT do, however, acknowledge more data are required to support this edict with current policies based on the National Joint Registry survivorship and implant costs.

Background. Modular dual mobility (MDM) acetabular components are often used to prevent dislocation in revision total hip arthroplasty (THA). As there is insufficient data on these components, the outcomes were evaluated in a cohort with a mean follow-up time of greater than five years. Methods. Using the database of a single academic center, 126 revision THAs (117 patients) with one MDM were retrospectively reviewed. There were 94 hips in 88 patients with a mean follow-up time of 5.5 years. Survivorship analysis was performed with the endpoints of dislocation, reoperation for dislocation, cup revision for aseptic loosening, and cup revision for any reason. The secondary endpoints were perioperative complications and radiographic review. Results. The overall rate of dislocation was 11%, with a 6-year survival of 91%. Reoperation for dislocation was performed in 7 patients (7%), with a 6-year survival of 94%. The dislocations were early (mean 33 days) in 6 patients, and late (mean 4.3 years) in 4 patients. There were three intraprosthetic dissociations. An outer head diameter of 48 mm or greater was associated with a lower risk of dislocation (p=0.013). Four hips (4%) were revised for aseptic cup loosening, and 14 (15%) cups were revised for infection. Two hips had visible metallic changes of the backside of the cobalt chromium liner. Conclusion. Using this MDM component in revision THA, at mean follow-up time of 5.5 years, there was a higher rate of dislocation (11%) than previously reported. Outer bearing size was related to the risk of dislocation. There was a low rate of aseptic cup loosening. Longer follow-up of this MDM component and evaluation of other designs is warranted

Aims

Dislocation remains a significant complication after total hip arthroplasty (THA), being the third leading indication for revision. We present a series of acetabular revision using a dual mobility cup (DMC) and compare this with our previous series using the posterior lip augmentation device (PLAD).