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Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_15 | Pages 18 - 18
1 Dec 2021
Warren J Anis H Bowers K Villa J Pannu T Klika AK Piuzzi N Colon-Franco J Higuera-Rueda C
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Aim

Several options to standardize the definition of periprosthetic joint infection (PJI) have been created including the 2013 Musculoskeletal Infection Society (MSIS), 2018 Intentional Consensus Meeting (ICM), and the 2019 proposed European Bone and Joint Infection Society (EBJIS) criteria. Synovial fluid biomarkers have been investigated in an effort to simplify and improve the diagnosis of PJI. The aim of this study was to test the sensitivity, specificity, positive, and negative predicted values (PPV and NPV, respectively) of a calprotectin point of care (POC) test for diagnosing PJI in revision total knee arthroplasty (TKA) patients comparing different sets of criteria (2013 MSIS, 2018 ICM, and 2019 EBJIS criteria) used to define patients as with or without infection.

Method

From October 2018 to January 2020 and under IRB approval 123 intraoperative samples of synovial fluid were prospectively collected at two academic hospitals in the same institution from revision TKA patients. All patients underwent standard clinical and laboratory evaluation for PJI at our institution, allowing for categorization using the 3 criteria. Patients were adjudicated by 2 blinded and independent reviewers for the 3 sets of criteria. The 3 criteria agreed 91.8% of the time. Four likely cases by the 2019 proposed EBJIS were considered unlikely and 1 inconclusive case by the 2018 ICM was considered not infected for the purposes of analysis. Calprotectin POC testing followed manufacturer's instructions using a threshold of >50 mg/L to indicate PJI. Sensitivities, specificities, PPV, NPV, and areas under the curve (AUC) were calculated for the 3 sets of criteria.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_15 | Pages 69 - 69
1 Dec 2021
Villa J Pannu T Theeb I Buttaro M Oñativia J Carbo L Rienzi D Fregeiro J Kornilov N Bozhkova S Sandiford N Higuera C Kendoff D Klika A
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Aim

It is unclear if the prevalence of resistance organisms causing (PJI) in total hip/knee arthroplasty is different among North/South American and European countries. Therefore, we sought to compare causative organisms, rates of resistant organisms, and polymicrobial infections in hospitals in North/South America, and Europe.

Method

We performed a retrospective study of 654 periprosthetic hip (n=361) and knee (n=293) infections (January 2006-October 2019) identified at two facilities in the United States (US) (n=159), and single institutions located in Argentina (n=99), Uruguay (n=130), United Kingdom (UK) (n=103), Germany (n=59), and Russia (n=104). The analyses were performed for the entire cohort, knees, and hips. Alpha was set at 0.05.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_15 | Pages 29 - 29
1 Dec 2021
Visperas A Piuzzi N Ju M Wickramasinghe S Anis H Milbrandt N Tsai YH Klika AK Barsoum W Samia A Higuera-Rueda C
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Aim

Periprosthetic joint infection (PJI) is a devastating complication of total joint arthroplasty. While research has focused on developing better tests for disease diagnosis, treatment options have stayed relatively constant over the years with high failure rates ranging from 30%–50% and are due in part to the protective biofilm produced by some bacterial species. Current treatment options are compromised by the presence of biofilm, emphasizing the need for novel treatment strategies to be developed. Our group has developed a novel treatment (PhotothermAA) which has demonstrated in vitro its ability to target bacterial biofilm. The purpose of this study was to test this PhotothermAA technology in vivo in a rabbit model of PJI for its efficacy in eradicating biofilm.

Method

Rabbits were fitted with a titanium implant into the tibial plateau and inoculated with 5×106 CFU Xen36 (luminescent Staphylococcus aureus). At two weeks, rabbits underwent irrigation and debridement and treatment with PhotothermAA gel for two hours and subsequently laser heated using an 808 nm laser for 10 minutes. Gel was washed out and implant was removed for quantitative biofilm coverage analysis via scanning electron microscopy (SEM, n=3 for control and n=2 for PhotothermAA treated). Periprosthetic tissue was collected before and after treatment for toxicity studies via hemotoxylin and eosin (H&E) staining and scored for necrosis by three blinded reviewers (n=5 per group). Student's t-test was used for statistical analysis.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_5 | Pages 1 - 1
1 Mar 2021
Warren J Anis H Klika AK Bowers K Pannu T Villa J Piuzzi N Colon-Franco J Higuera-Rueda C
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Aim

Despite several synovial fluid biomarkers for diagnosis of periprosthetic joint infection (PJI) have being investigated, point-of-care (POC) tests using these biomarkers are not widely available. Synovial calprotectin has recently been reported to effectively exclude diagnosis of PJI and a novel lateral flow POC test using it has shown potential to be effective. Thus, the aims of this study were to 1) validate calprotectin POC with enzyme linked immunosorbet assay (ELISA) 2) at 2 separate thresholds for PJI diagnosis in total knee arthroplasty (TKA) patients using the 2013 Musculoskeletal Infection Society (MSIS) PJI diagnosis criteria as the gold standard.

Method

Intraoperative synovial fluid samples were prospectively collected from 123 patients who underwent revision TKAs (rTKA) at two academic hospitals within the same healthcare system from October 2018 to January 2020. The study was conducted under IRB approval. Included patients followed the hospital standard for their PJI diagnostic work-up. Data collection included demographic, clinical, and laboratory data in compliance with MSIS criteria. Synovial fluid samples were analysed by calprotectin POC and ELISA tests in accordance with manufacturer's instructions. Patients were categorized as septic or aseptic using MSIS criteria by two independent reviewers blinded to calprotectin assay results. The calprotectin POC and ELISA test performance characteristics were calculated with sensitivities, specificities, positive, and negative predicted values (PPV and NPV, respectively) and areas under the curve (AUC) for 2 different PJI diagnosis scenarios: (1) a threshold of >50 mg/L and (2) a threshold of >14 mg/L.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_5 | Pages 2 - 2
1 Mar 2021
Higuera-Rueda C Emara A Nieves-Malloure Y Klika AK Cooper H Cross M Guild G Nam D Nett M Scuderi G Cushner F Silverman R
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Aim

This was a multicenter, randomized, clinical trial to compare the 90-day 1) incidence of surgical site complications (SSC); 2) health care utilization (the number of dressing changes, readmission, and reoperation); and 3) the patient-reported outcomes (PRO) in high-risk patients undergoing revision total knee arthroplasty (rTKA) with postoperative closed incision negative pressure wound therapy (ciNPT) versus a standard of care (SOC) silver-impregnated occlusive dressing.

Method

A total of 294 rTKA patients (15 centers) at high-risk for wound complications were prospectively randomized to receive either SOC or ciNPT (n = 147 each). The ciNPT system was adjusted at 125 mmHg of suction. Investigated outcomes were assessed weekly up to 90 days after surgery. A preset interim analysis was conducted at 50% of the intended sample size, with planned discontinuation for clear efficacy/harm if a significance of p < 0.005 was attained.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_9 | Pages 7 - 7
1 Oct 2020
Goswami K Clarkson S Dennis DA Klatt BA O'Malley M Smith EL Pelt CE Gililland J Peters C Malkani AL Palumbo B Minter J Goyal N Cross M Prieto H Lee G Hansen E Ward D Bini S Higuera C Levine B Nam D Della Valle CJ Parvizi J
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Introduction

Surgical management of PJI remains challenging with patients failing treatment despite the best efforts. An important question is whether these later failures reflect reinfection or the persistence of infection. Proponents of reinfection believe hosts are vulnerable to developing infection and new organisms emerge. The alternative hypothesis is that later failure is a result of an organism that was present in the joint but was not picked up by initial culture or was not a pathogen initially but became so under antibiotic pressure. This multicenter study explores the above dilemma. Utilizing next-generation sequencing (NGS), we hypothesize that failures after two stage exchange arthroplasty can be caused by an organism that was present at the time of initial surgery but not isolated by culture.

Methods

This prospective study involving 15 institutions collected samples from 635 revision total hip (n=310) and knee (n=325) arthroplasties. Synovial fluid, tissue and swabs were obtained intraoperatively for NGS analysis. Patients were classified per 2018 Consensus definition of PJI. Treatment failure was defined as reoperation for infection that yielded positive cultures, during minimum 1-year follow-up. Concordance of the infecting pathogen cultured at failure with NGS analysis at initial revision was determined.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 116 - 116
1 Apr 2019
Gordon A Golladay G Bradbury TL Fernandez-Madrid I Krebs VE Patel P Higuera C Barsoum W Suarez J
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Introduction & Aims

Studies have shown that as many as 1 in 5 patients is dissatisfied following total knee replacement (TKA). There has also been a large reported disparity between surgeon and patient perception of clinical “success”. It has long been shown that surgeon opinion of procedural outcomes is inflated when compared with patient-reported outcomes. Additionally, TKA recipients have consistently reported higher pain levels, greater inhibition of function, and lower satisfaction than total hip replacement (THA) recipients. It is imperative that alternative methods be explored to improve TKA patient satisfaction. Therefore, the purpose of this study was to determine whether or not patients with a balanced TKA, as measured using intraoperative sensors, exhibit better clinical outcomes.

Methods

310 patients scheduled for TKA surgery were enrolled in a 6 center, randomized controlled trial, resulting in two patient groups: a sensor-guided TKA group and a surgeon-guided TKA group. Intraoperative load sensors were utilized in all cases, however in one group the surgeon used the feedback to assist in balancing the knee and in the other group the surgeon balanced without load data and the sensor was used to blindly record the joint balance. For this evaluation, the two groups were pooled and categorized as either balanced or unbalanced, as defined by a mediolateral load differential less than 15 lbf (previously described in literature). Clinical outcomes data were collected at 6 weeks, 6 months and 1 year post- operatively, including Knee Society Satisfaction and the Forgotten Joint Score. Using linear mixed models, these outcome measures were compared between the balanced and unbalanced patient groups.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 56 - 56
1 Apr 2019
Goswami K Cho JE Manrique J Tan T Higuera C Della Valle C Parvizi J
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Introduction

The use of irrigation solution during surgical procedures is a common and effective practice in reduction of bioburden and the risk of subsequent infection. The optimal irrigation solution to accomplish this feat remains unknown. Many surgeons commonly add topical antibiotics to irrigation solutions assuming this has topical effect and eliminates bacteria. The latter reasoning has never been proven. In fact a few prior studies suggest addition of antibiotics to irrigation solution confers no added benefit. Furthermore, this practice adds to cost, has the potential for anaphylactic reactions, and may also contribute to the emergence of antimicrobial resistance. We therefore sought to compare the antimicrobial efficacy and cytotoxicity of irrigation solution containing polymyxin-bacitracin versus other commonly used irrigation solutions.

Methods

Using two in vitro breakpoint assays of Staphylococcus aureus (ATCC#25923) and Escherichia coli (ATCC#25922), we examined the efficacy of a panel of irrigation solutions containing topical antibiotics (500,000U/L Polymyxin-Bacitracin 50,000U/L; Vancomycin 1g/L; Gentamicin 80mg/L), as well as commonly used irrigation solutions (Normal saline 0.9%; Povidone-iodine 0.3%; Chlorhexidine 0.05%; Castile soap 0.45%; and Sodium hypochlorite 0.125%) following 1 minute and 3 minutes of exposure. Surviving bacteria were counted in triplicate experiments. Failure to eradicate all bacteria was considered to be “not effective” for that respective solution and exposure time.

Cytotoxicity analysis in human fibroblast, osteoblast, and chrondrocyte cells exposed to each of the respective irrigation solutions was performed by visualization of cell structure, lactate dehydrogenase (LDH) activity and evaluation of vital cells. Toxicity was quantified by determination of LDH release (ELISA % absorbance; with higher percentage considered a surrogate for cytotoxicity). Descriptive statistics were used to present means and standard deviation of triplicate experimental runs.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_1 | Pages 58 - 58
1 Jan 2018
Newman J Khlopas A Sodhi N Curtis G Sultan A Higuera C Mont M
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Patients who have multiple sclerosis (MS) may be at increased risk of developing complications after total hip arthroplasty (THA). The purpose of this study was to compare: 1) implant survivorship; 2) functional outcomes; 3) complication rates; and 4) radiographic findings after THA between MS patients and a matched cohort.

A single institutional database was reviewed for patients who had a diagnosis of MS and underwent a THA. Thirty-four patients (41 hips) were matched to a 2:1 cohort who did not have MS using based on age, sex, body mass index (BMI), and Charlson/Deyo scores. This resulted in a matching cohort of 80 patients (82 hips). The available medical records were reviewed. Functional outcomes and complications were assessed. Postoperative radiographs were evaluated.

The matching cohort had higher all-cause survivorship at 4-years postoperatively (99 vs. 93%). There were 3 revisions in the MS cohort and 0 revisions in the matching cohort. The MS cohort had lower mHHS scores (66 vs.74 points, p<0.001), lower HOOS JR scores (79 vs. 88 points, p<0.01), required more physical therapy (5 vs. 3 weeks, p<0.01), and took longer to return to their baseline functional level (7 vs. 5 weeks, p<0.05). MS patients had higher rate of complications (6 vs. 1, p<0.05). Excluding revision cases, there was no additional radiographic evidence of progressive radiolucency, loosening, or subsidence.

We found that MS patients had lower implant survivorship, lower functional outcome scores, and increased complication rates. These findings may help orthopaedists to have a better knowledge of how MS patients do after THA.


The Bone & Joint Journal
Vol. 100-B, Issue 1_Supple_A | Pages 68 - 75
1 Jan 2018
Goel R Fleischman AN Tan T Sterbis E Huang R Higuera C Parvizi J Rothman RH

Aims

The aims of this study were to compare the efficacy of two agents, aspirin and warfarin, for the prevention of venous thromboembolism (VTE) after simultaneous bilateral total knee arthroplasty (SBTKA), and to elucidate the risk of VTE conferred by this procedure compared with unilateral TKA (UTKA).

Patients and Methods

A retrospective, multi-institutional study was conducted on 18 951 patients, 3685 who underwent SBTKA and 15 266 who underwent UTKA, using aspirin or warfarin as VTE prophylaxis. Each patient was assigned an individualised baseline VTE risk score based on a system using the Nationwide Inpatient Sample. Symptomatic VTE, including pulmonary embolism (PE) and deep vein thrombosis (DVT), were identified in the first 90 days post-operatively. Statistical analyses were performed with logistic regression accounting for baseline VTE risk.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_22 | Pages 27 - 27
1 Dec 2016
Higuera C
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Background

The clinical benefit of chronic suppression with oral antibiotics as a salvage treatment for periprosthetic joint infection is unclear. The purpose of this study was to compare infection-free prosthetic survival rates between patients who received chronic oral antibiotics and those who did not following irrigation and debridement with polyethylene exchange or two-stage revision for periprosthetic joint infection.

Methods

We reviewed the records on all irrigation and debridement procedures with polyethylene exchange and two-stage revisions performed at our institution from 1996 to 2010 for hip or knee periprosthetic joint infection. Of 625 patients treated with a total of 655 eligible revisions, ninety-two received chronic oral antibiotics for a minimum of six months and were eligible for inclusion in our study. These patients were compared with a matched cohort (ratio of 1:3) who did not receive chronic oral antibiotics.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 7 - 7
1 May 2016
Longaray J Hooks B Herrera L Essner A Higuera C
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Prosthetic Hip dislocations remain one of the most common major complications after total hip arthroplasty procedures, which has led to much debate and refinement geared to the optimization of implant and bearing options, surgical approaches, and technique. The implementation of larger femoral heads has afforded patients a larger excursion distance and primary arc range motion before impingement, leading to lowered risk of hip dislocation. However, studies suggest that while the above remains true, the use of larger heads may contribute to increased volumetric wear, trunnion related corrosion, and an overall higher prevalence of loosening, pain, and patient dissatisfaction, which may require revision hip arthroplasty. More novel designs such as the dual mobility hip have been introduced into the United States to optimize stability and range of motion, while possibly lowering the frictional torque and modes of failure associated with larger fixed bearing articulations. Therefore, the aim of this study is to compare the effect of bearing design and anatomic angles on frictional torque using a clinically relevant model8.

Two bearing designs at various anatomical angles were used; a fixed and a mobile acetabular component at anatomical angles of 0°,20°,35°,50°, and 65°. The fixed design consisted of a 28/56mm inner diameter/outer diameter acetabular hip insert that articulated against a 28mm CoCr femoral head (n=6). The mobile design consisted of a 28mm CoCr femoral head into a 28/56mm inner diameter/outer diameter polyethylene insert that articulates against a 48mm metal shell (n=6). The study was conducted dynamically following a physiologically relevant frictional model8.

A statistical difference was found only between the anatomical angles comparison of 0vs65 degrees in the mobile bearing design. In the fixed bearing design, a statistical difference was found between the anatomical angles comparison of 20vs35 degrees, 20vs50 degrees, and 35vs65 degrees. No anatomical angle effect on frictional torque between each respective angle or bearing design was identified. Frictional torque was found to decrease as a function of anatomical angle for the fixed bearing design (R2=0.7347), while no difference on frictional torque as a function of anatomical angle was identified for the mobile bearing design. (R2=0.0095)

These results indicate that frictional torque for a 28mm femoral head is not affected by either anatomical angle or bearing design. This data suggests that mobile design, while similar to the 28mm fixed bearing, may provide lower frictional torque when compared to larger fixed bearings >or= 32mm8. Previous work by some of the authors [8] show that frictional torque increases as a function of femoral head size. Therefore, this option may afford surgeons the ability to achieve optimal hip range of motion and stability, while avoiding the reported complications associated with using larger fixed bearing heads8. It is important to understand that frictional behavior in hip bearings may be highly sensitive to many factors such as bearing clearance, polyethylene thickness/stiffness, polyethylene thickness/design, and host related factors, which may outweigh the effect of bearing design or cup abduction angle. These factors were not considered in this study.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 541 - 541
1 Dec 2013
Higuera C Styron J Strnad G Barsoum W Iannotti J
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Introduction:

Patient medical comorbidities are well-established risk modifiers of THA patient outcomes. Patient's mental state preoperatively may influence postoperative functional outcomes though just like any medical comorbidity. This study sought to determine if patient confidence in attaining post-operative functional goals was associated with objective and subjective outcomes following THA.

Methods:

Patients undergoing primary or revision THA at a single institution between 2008 and 2010 were administered a questionnaire consisting of demographics, body mass index, Hip Dysfunction Osteoarthritis and Outcomes Score (HOOS), SF-12 scores, the level of functionality they hoped to gain postoperatively and their confidence in attaining that goal (0–10 scale) preoperatively and postoperatively at last follow-up (minimum 12 months). Measured outcomes included length of stay, 30-day readmission, HOOS, and SF-12 physical component scores. Correlation of patient confidence in attaining treatment goals and the outcomes collected was established using multiple linear and logistic regression models that were adjusted for all variables, including baseline mental and functional scores.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 348 - 348
1 Dec 2013
Higuera C Styron J Strnad G Iannotti J
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Introduction:

Total knee arthroplasty (TKA) outcomes drive assessment of quality and reinvestment; therefore a risk stratified assessment is paramount for fair evaluation. Stratification can be affected by multiple factors including patient motivation. This study attempted to identify the correlation of patient's preoperative confidence in their ability to return to desired activity level after TKA and improved function and outcomes.

Methods:

A continuous series of TKA procedures from 2008 to 2010 in a healthcare system was reviewed retrospectively. Patients included reported pre- and postoperative knee injury and osteoarthritis outcomes scores (KOOS), SF-12 scores, and responded a question regarding the desired activity level, including the level of confidence (0–10 scale) in attaining such goals, after surgery. Gender, age, body mass index, education level, smoking status, length of stay (LOS), 30-day readmission and reoperation, and 1-year infection rates were collected. Correlation of patient confidence in attaining treatment goals and the outcomes collected was established using multiple linear and logistic regression models adjusted for baseline mental and functional scores.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 518 - 518
1 Dec 2013
Saleh A Gad B Higuera C Klika A Iannotti J Barsoum W
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Background:

Acetabular component malpositioning in total hip arthroplasty increases the risk of dislocations, impingement, and long-term component wear. The purpose of this Sawbones study was to define the efficacy of a novel acetabular imprinting device (AID) with 3D preoperative planning in accurately placing the acetabular component.

Methods:

Four surgeons performed the study on osteoarthritic and dysplastic Sawbone models using 3 different methods for placing the acetabular component (total n = 24). The 3 methods included (1) standard preoperative planning and instrumentation (i.e., standard method), (2) 3D computed tomographic (CT) scan planning and standard instrumentation (i.e., 3D planning method), and (3) 3D CT scan planning combined with an acetabular imprinting device (i.e., AID method). In the AID method, 3D planning software was used to virtually place the acetabular component at 40° of inclination and 22° of anteversion and create a parallel guide pin trajectory. A patient-specific surrogate bone model with a built-in guide pin trajectory was then manufactured as a stereoltihography device (Fig. 1A). The surgeon molded bone cement into the acetabulum imprinting the acetabular features while maintaining the guide pin trajectory (Fig. 1B). Afterward, the AID was removed from the surrogate bone model and placed onto the Sawbone, ensuring a secure fit (Fig. 1C). A guide pin was drilled into the Sawbone along the prescribed trajectory. With the guide pin in place, the surgeon could ream the acetabulum and impact the acetabular component using the guide pin as a visual aid (Fig. 1D). Postoperatively, a CT scan was used to define and compare the actual implant location with the preoperative plan. Statistical analysis was performed as 3 group comparisons using the chi-squared test for categorical data and analysis of variance (ANOVA) for continuous measurements.


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 6 | Pages 839 - 845
1 Jun 2007
Barsoum WK Patterson RW Higuera C Klika AK Krebs VE Molloy R

Dislocation remains a major concern after total hip replacement, and is often attributed to malposition of the components. The optimum position for placement of the components remains uncertain. We have attempted to identify a relatively safe zone in which movement of the hip will occur without impingement, even if one component is positioned incorrectly. A three-dimensional computer model was designed to simulate impingement and used to examine 125 combinations of positioning of the components in order to allow maximum movement without impingement. Increase in acetabular and/or femoral anteversion allowed greater internal rotation before impingement occurred, but decreases the amount of external rotation. A decrease in abduction of the acetabular components increased internal rotation while decreasing external rotation. Although some correction for malposition was allowable on the opposite side of the joint, extreme degrees could not be corrected because of bony impingement.

We introduce the concept of combined component position, in which anteversion and abduction of the acetabular component, along with femoral anteversion, are all defined as critical elements for stability.