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The Bone & Joint Journal
Vol. 105-B, Issue 12 | Pages 1279 - 1285
1 Dec 2023
Baker JF Nadar AC Jouflas AC Smith LS Sachdeva S Yakkanti MR Malkani AL

Aims

The use of cementless total knee arthroplasty (TKA) components has increased during the past decade. The initial design of cementless metal-backed patellar components had shown high failure rates due to many factors. The aim of this study was to evaluate the clinical results of a second-generation cementless, metal-backed patellar component of a modern design.

Methods

This was a retrospective review of 707 primary TKAs in 590 patients from a single institution, using a cementless, metal-backed patellar component with a mean follow-up of 6.9 years (2 to 12). A total of 409 TKAs were performed in 338 females and 298 TKAs in 252 males. The mean age of the patients was 63 years (34 to 87) and their mean BMI was 34.3 kg/m2 (18.8 to 64.5). The patients were chosen to undergo a cementless procedure based on age and preoperative radiological and intraoperative bone quality. Outcome was assessed using the Knee Society knee and function scores and range of motion (ROM), complications, and revisions.


Bone & Joint Open
Vol. 3, Issue 7 | Pages 589 - 595
1 Jul 2022
Joo PY Chen AF Richards J Law TY Taylor K Marchand K Clark G Collopy D Marchand RC Roche M Mont MA Malkani AL

Aims

The aim of this study was to report patient and clinical outcomes following robotic-assisted total knee arthroplasty (RA-TKA) at multiple institutions with a minimum two-year follow-up.

Methods

This was a multicentre registry study from October 2016 to June 2021 that included 861 primary RA-TKA patients who completed at least one pre- and postoperative patient-reported outcome measure (PROM) questionnaire, including Forgotten Joint Score (FJS), Knee Injury and Osteoarthritis Outcomes Score for Joint Replacement (KOOS JR), and pain out of 100 points. The mean age was 67 years (35 to 86), 452 were male (53%), mean BMI was 31.5 kg/m2 (19 to 58), and 553 (64%) cemented and 308 (36%) cementless implants.


The Bone & Joint Journal
Vol. 103-B, Issue 6 Supple A | Pages 59 - 66
1 Jun 2021
Abhari S Hsing TM Malkani MM Smith AF Smith LS Mont MA Malkani AL

Aims

Alternative alignment concepts, including kinematic and restricted kinematic, have been introduced to help improve clinical outcomes following total knee arthroplasty (TKA). The purpose of this study was to evaluate the clinical results, along with patient satisfaction, following TKA using the concept of restricted kinematic alignment.

Methods

A total of 121 consecutive TKAs performed between 11 February 2018 to 11 June 2019 with preoperative varus deformity were reviewed at minimum one-year follow-up. Three knees were excluded due to severe preoperative varus deformity greater than 15°, and a further three due to requiring revision surgery, leaving 109 patients and 115 knees to undergo primary TKA using the concept of restricted kinematic alignment with advanced technology. Patients were stratified into three groups based on the preoperative limb varus deformity: Group A with 1° to 5° varus (43 knees); Group B between 6° and 10° varus (56 knees); and Group C with varus greater than 10° (16 knees). This study group was compared with a matched cohort of 115 TKAs and 115 patients using a neutral mechanical alignment target with manual instruments performed from 24 October 2016 to 14 January 2019.


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. 102-B, Issue SUPP_9 | Pages 65 - 65
1 Oct 2020
Abhari S Hsing T Malkani M Smith AF Smith LS Malkani AL
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Introduction

Mechanical axis limb alignment in total knee arthroplasty (TKA) has demonstrated excellent long-term survivorship; however, patient satisfaction continues to demand improvement. Alternative emerging alignment concepts including kinematic and tibial constitutional varus have been introduced but remain controversial. The purpose of this study was to evaluate outcomes and patient satisfaction following TKA with tibial components placed in constitutional varus alignment.

Methods

This was a retrospective cohort analysis from a total joint registry of 114 patients with preoperative varus deformity who underwent primary TKA with tibial component placed in 1–3 degrees of constitutional varus. The group included 59 males (52%) and 55 (48%) females with a mean age of 67 years (range 43 – 85) and mean BMI of 32.0 kg/m2 (range 21 – 51 kg/m2) with a minimum 1 year follow-up. Patients were stratified into 3 groups based on the preoperative varus alignment: Group A between 1°- 5° varus (43 knees), Group B between 6°- 10° (56 knees), and Group C greater than 10° (16 knees). The target constitutional tibial varus alignment was selected based on the extent of the patient's deformity.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_11 | Pages 52 - 52
1 Oct 2019
Korte EA Malkani AL Gaskins J Hartley B Langman LJ Jannetto P McMillin G Maluf C Jortani SA
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Introduction

Insufficient pain control following lower extremity surgery can increase length of stay, readmission rates, and impair postoperative outcome. It has been shown that CYP2D6 genotypes predict function of the enzyme responsible for conversion of hydrocodone to hydromorphone (active metabolite) and plasma concentration of hydromorphone best predicted analgesic response. Purpose of this study was to evaluate relationship of CYP2D6 genotypes, drug-drug interactions, and plasma drug concentrations in patients undergoing lower extremity surgery.

Methods

A prospective cohort of 271 orthopedic patients undergoing lower extremity surgery including TKA, THA and trauma were queried. Patients treated with hydrocodone were enrolled and tested for plasma concentrations of hydrocodone and hydromorphone. CYP2D6 genotyping was performed. Medications co-administered with hydrocodone during perioperative and postoperative periods were queried.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_12 | Pages 73 - 73
1 Oct 2019
Sershon RA Fillingham Y Abdel MP Malkani AL Schwarzkopf R Padgett DE Vail TP Nam D Nahhas CR Culvern C Valle CJD
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Background

The purpose of this multicenter, randomized clinical trial was to determine the optimal dosing regimen of tranexamic acid (TXA) to minimize perioperative blood loss for revision total hip arthroplasty (THA).

Methods

Six centers prospectively randomized 155 revisions to one of four regimens: 1g of intravenous (IV) TXA prior to incision, a double dose regimen of 1g IV TXA prior to incision and 1g IV TXA during wound closure, a combination of 1g IV TXA prior to incision and 1g intraoperative topical TXA, or three doses of 1950mg oral TXA administered 2 hours preoperatively, 6 hours postoperatively, and on the morning of postoperative day one. Randomization was based upon revision subgroups to ensure equivalent group distribution, including: femur only, acetabulum only, both component, explant/spacer, and second stage reimplantation. Patients undergoing an isolated modular exchange were excluded. An a priori power analysis (alpha = 0.05; beta = 0.80) determined 40 patients per group were required to identify a 1g/dL difference in postoperative hemoglobin reduction between groups. Per-protocol analysis involved an analysis of variance, Fisher's exact tests, and two one-sided t-tests for equivalence.


The Bone & Joint Journal
Vol. 101-B, Issue 7_Supple_C | Pages 10 - 16
1 Jul 2019
Fillingham YA Darrith B Calkins TE Abdel MP Malkani AL Schwarzkopf R Padgett DE Culvern C Sershon RA Bini S Della Valle CJ

Aims

Tranexamic acid (TXA) is proven to reduce blood loss following total knee arthroplasty (TKA), but there are limited data on the impact of similar dosing regimens in revision TKA. The purpose of this multicentre randomized clinical trial was to determine the optimal regimen to maximize the blood-sparing properties of TXA in revision TKA.

Patients and Methods

From six-centres, 233 revision TKAs were randomized to one of four regimens: 1 g of intravenous (IV) TXA given prior to the skin incision, a double-dose regimen of 1 g IV TXA given both prior to skin incision and at time of wound closure, a combination of 1 g IV TXA given prior to skin incision and 1 g of intraoperative topical TXA, or three doses of 1950 mg oral TXA given two hours preoperatively, six hours postoperatively, and on the morning of postoperative day one. Randomization was performed based on the type of revision procedure to ensure equivalent distribution among groups. Power analysis determined that 40 patients per group were necessary to identify a 1 g/dl difference in the reduction of haemoglobin postoperatively between groups with an alpha of 0.05 and power of 0.80. Per-protocol analysis involved regression analysis and two one-sided t-tests for equivalence.


The Bone & Joint Journal
Vol. 101-B, Issue 7_Supple_C | Pages 3 - 9
1 Jul 2019
Shohat N Tarabichi M Tan TL Goswami K Kheir M Malkani AL Shah RP Schwarzkopf R Parvizi J

Aims

The best marker for assessing glycaemic control prior to total knee arthroplasty (TKA) remains unknown. The purpose of this study was to assess the utility of fructosamine compared with glycated haemoglobin (HbA1c) in predicting early complications following TKA, and to determine the threshold above which the risk of complications increased markedly.

Patients and Methods

This prospective multi-institutional study evaluated primary TKA patients from four academic institutions. Patients (both diabetics and non-diabetics) were assessed using fructosamine and HbA1c levels within 30 days of surgery. Complications were assessed for 12 weeks from surgery and included prosthetic joint infection (PJI), wound complication, re-admission, re-operation, and death. The Youden’s index was used to determine the cut-off for fructosamine and HbA1c associated with complications. Two additional cut-offs for HbA1c were examined: 7% and 7.5% and compared with fructosamine as a predictor for complications.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_13 | Pages 9 - 9
1 Oct 2018
Malkani AL Denehy K Ong K Hagan D
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Introduction

Cephalomedullary nails (CMN) are commonly used for the treatment of intertrochanteric (IT) hip fractures. Total hip arthroplasty (THA) is commonly used as a salvage procedure for failed IT hip fractures that progress to post-traumatic arthritis. This study analyzed the complications of THA following treatment of failed IT hip fractures with cephalomedullary nails.

Methods

Patients who had a primary THA were identified from the 5% subset of Medicare Parts A/B from 2002–2015. A subgroup with previous CMN for IT hip fracture within the previous 5 years was identified and compared to the remaining THA patients without prior CMN. Length of stay (LOS) was compared using both univariate and multivariate analysis. Infection, dislocation, revision, and readmission were compared between those with and without prior CMN, using multivariate analysis (adjusted for demographic, hospital, and clinical factors).


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_12 | Pages 48 - 48
1 Oct 2018
Fillingham YA Darrith B Calkins T Abdel MP Malkani AL Schwarzkopf R Padgett DE Sershon RA Bini S Della Valle CJ
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Introduction

Tranexamic acid (TXA) is proven to reduce blood loss following total knee arthroplasty (TKA), but there are limited data on the impact of similar dosing regimens in revision TKA that is associated with greater blood loss. The purpose of this multi-center randomized trial was to determine the optimal regimen to maximize the blood-sparing properties of TXA in revision TKA.

Methods

233 Septic and aseptic revision TKA from six-centers were randomized to either receive 1g pre-incision intravenous (IV) TXA, 1g pre- and post-incision IV TXA, 1g pre-incision IV and 1g intra-operative topical TXA, or three doses of 1950mg oral TXA given 2 hours pre-operatively, 6 hours post-operatively, and the morning of postoperative day 1. Randomization was performed based on type of revision to ensure equivalent distribution among groups. The primary outcome was reduction in hemoglobin. Power analysis determined 40 patients per group were necessary to identify a 1g/dL difference with an alpha of 0.05 and beta of 0.80. Per-protocol analysis involved regression analysis and two one-sided t-tests for equivalence.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 3 - 3
1 Jan 2016
MacDonald D Baykal D Underwood R Malkani AL Parvizi J Kurtz SM
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Introduction

First-generation annealed HXLPE has been clinically successful at reducing both clinical wear rates and the incidence of osteolysis in total hip arthroplasty. However, studies have observed oxidative and mechanical degradation occurring in annealed HXLPE. Thus, it is unclear whether the favorable clinical performance of 1st generation HXLPE is due to the preservation of bearing surface tribological properties or, at least partially, to the reduction in patient activity. The purpose of this study was to evaluate the in vitro wear performance (assessed using multidirectional pin-on-disk (POD) testing) of 1st-generation annealed HXLPE with respect to in vivo duration, clinical wear rates, oxidation, and mechanical properties.

Materials and Methods

103 1st-generation annealed HXLPE liners were collected at revision surgery. 39 annealed HXLPE liners were selected based on their implantation time and assigned to three equally sized cohorts (n=13 per group); short-term (1.4–2.7y), intermediate term (5.2–8.0y) and long-term (8.3–12.5y). From each retrieved liner, two 9-mm cores were obtained (one from the superior region and one from the inferior region). Sixteen cores were fabricated from unimplanted HXLPE liners that were removed from their packaging and six pins from unirradiated GUR 1050 resin served as positive controls. Multidirectional POD wear testing was conducted against wrought CoCr disks in a physiologically relevant lubricant (20 g/L protein concentration) using a 100-station SuperPOD (Phoenix Tribology, UK). Each pin had its own chamber with 15mL lubricant maintained at 37±1°C. An elliptical wear pattern with a static contact stress of 2.0 MPa was employed. Testing was carried out to 1.75 million cycles at 1.0 Hz and wear was assessed gravimetrically. POD wear rates were calculated using a linear regression of volumetric losses. In vivo penetration was measured directly using a calibrated micrometer. Oxidation was assessed on thin films obtained from superior and inferior regions of the liners (ASTM 2102). Mechanical properties were assessed using the small punch test (ASTM 2183).


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_4 | Pages 82 - 82
1 Jan 2016
Ramakrishnan R Tsurumoto M Malkani AL
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Introduction

Technological advances in the processing of polyethylene have led to improved survivorship of total hip arthroplasty. The purpose of this study was to determine if a second generation highly cross-linked polyethylene could improve upon wear rates compared to conventional and first generation cross-linked polyethylene in patients undergoing primary total hip arthroplasty.

Methods

Linear and volumetric wear rates of a second generation highly cross-linked polyethylene were evaluated following primary total hip arthroplasty. There were 44 patients with an average age of 68.6 years and mean follow-up of 5.3 years. Patients were evaluated at six weeks, one, two and five years. Wear rates were determined from digitized AP Pelvis radiograph by an independent observer using Martell's software. Acetabular inclination and femoral head size were also evaluated to determine variability in wear rates.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 26 - 26
1 Jan 2016
Arnholt C Kocagoz S MacDonald D Gilbert J Parvizi J Malkani AL Klein GR Kraay M Rimnac C Kurtz S
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Introduction

The release of metal debris and ions has raised concerns in joint arthroplasty. In THA metal debris and ions can be generated by wear of metal-on-metal bearing surfaces and corrosion at modular taper interfaces, currently understood to be mechanically assisted crevice corrosion (MACC) [1]. More recently, inflammatory-cell induced corrosion (ICIC) has been identified as a possible source of metal debris and/or ions [2]. Although MACC has been shown to occur at modular junctions in TKA, little is known about the prevalence of other sources. The purpose of this study was to determine the sources of metallic debris and ion release in long-term implanted (in vivo > 15y) TKA femoral components. Specific attention was paid to instances of ICIC as well as damage at the implant-bone interface.

Methods

1873 retrieved TKA components were collected from 2002–2013 as part of a multi-center, IRB-approved retrieval program. Of these, 52 CoCr femoral condyles were identified as long term TKA (Average: 17.9±2.8y). These components were predominantly revised for loosening, PE wear and instability. 40/52 of the components were primary surgeries. Components were examined using optical microscopy to confirm the presence of 5 damage mechanisms (polyethylene failure, MACC corrosion of modular tapers, corrosion damage between cement and backside, third-body wear, and ICIC). Third-body wear was evaluated using a semi-quantitative scoring method based on the percentage of damaged area. A score of 1 had minimal damage and a score of 4 corresponded to severe damage. Polyethylene components were scored using the Hood method and CoCr components were scored similarly to quantify metal wear. The total area damaged by ICIC was quantified using photogrammetry. Images were taken using a digital SLR with a calibrated ruler in the same focal plane. Using known pixel dimensions, the ICIC damaged area was calculated.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 386 - 386
1 Dec 2013
Kurtz S Zielinska O MacDonald D Cates H Mont M Malkani AL Parvizi J Rimnac C
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Introduction:

First generation highly crosslinked polyethylenes (HXPLEs) have proven successful in lowering both penetration and osteolysis rates. However, 1st generation annealing and remelting thermal stabilization have been associated with in vivo oxidation or reduced mechanical properties. Thus, 2nd generation HXLPEs were developed to improve oxidative stability while still maintaining material properties. Little is known about the in vivo clinical failure modes of these 2nd generation HLXPEs.

The purpose of this study was to assess the revision reasons, wear, oxidative stability, and mechanical behavior of retrieved sequentially annealed Vitamin E diffused HXLPE in THA and TKA.

Methods:

251 2nd Generation HXLPE hip and knee components were consecutively retrieved during revision surgeries and continuously analyzed in a prospective, IRB approved, multicenter study. 123 acetabular liners (Implanted 1.2y; Range 0–5.0y) and 117 tibial inserts (Implanted 1.6y; Range 0–5.8y) were highly crosslinked and annealed in 3 sequential steps (X3). Five acetabular liners (Implanted 0.6y; Range 0–2.0y) and six tibial inserts (Implanted 1.3y; Range 0.5–1.8y) were diffused with Vitamin E (E1). Patient information was collected from medical records (Table 1).

Linear penetration of liners was measured using a calibrated digital micrometer (accuracy: 0.001 mm). Surface damage of tibial components was assessed using the Hood method. Thin sections were taken from the acetabular liners (along the superior/inferior axis) and the tibial components (along the medial condyle and central spine) for oxidation analysis and analyzed according to ASTM 2102. Mechanical behavior was assessed via the small punch test (ASTM 2183).


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 107 - 107
1 Mar 2013
Kurtz S MacDonald D Parvizi J Klein GR Lee G Marshall A Mont M Kraay M Stulberg B Malkani AL Rimnac C
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Introduction

The purpose of this multicenter study was to assess the oxidative stability, mechanical behavior, wear and reasons for revision of 2nd generation sequentially annealed HXLPE, X3, and compare it to 1st generation XLPE, Crossfire. We hypothesized that X3 would exhibit similar wear rates but lower oxidation than Crossfire.

Methods

182 hip liners were consecutively retrieved during revision surgeries at 7 surgical centers and continuously analyzed over the past 12 years in a prospective, multicenter study. 90 were highly crosslinked and annealed (Crossfire; Implanted 4.2±3.4 years, max: 11 years), and 92 were highly crosslinked and annealed in 3 sequential steps (X3; Implanted 1.2±1.5 years; max: 5 years). Oxidation was characterized in accordance with ASTM 2102 using transmission FTIR performed on thin sections (∼200μm) from the superior/inferior axis. Mechanical behavior was assessed via the small punch test (ASTM 2183).


The Journal of Bone & Joint Surgery British Volume
Vol. 79-B, Issue 5 | Pages 874 - 875
1 Sep 1997
MALKANI AL


The Journal of Bone & Joint Surgery British Volume
Vol. 78-B, Issue 6 | Pages 973 - 978
1 Nov 1996
Malkani AL Voor MJ Fee KA Bates CS

We have tested the axial and torsional stability of femoral components after revision arthroplasty in a cadaver model, using impacted morsellised cancellous graft and cement. Each one of six matched pairs of fresh frozen human femora had either a primary or a revision prosthesis cemented in place. For the ‘revision’ experiments, all cancellous bone was removed from the proximal femur which was then over-reamed to create a smooth-walled cortical shell. An MTS servohydraulic test frame was used to apply axial and torsional loads to each specimen through the prosthetic femoral heads with the femur submerged in isotonic saline solution at 37°C.

The mean subsidence was 0.27 ± 0.17 mm for the primary and 0.52 ± 0.30 mm for the revision groups. The difference was statistically significant (p < 0.025), but the mean subsidence was < 1 mm in both groups. The mean maximum torque before failure was 42.9 ± 26.9 N-m for the primary and 34.8± 20.7 N-m for the revision groups. This difference was not statistically significant (p > 0.015).

Based on our results we suggest that revision of the femoral component using morsellised cancellous graft followed by cementing with a collarless prosthesis with a polished tapered stem restores the integrity of the proximal femur and provides immediate stability of the implant.