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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 63 - 63
19 Aug 2024
Tsikandylakis G Mortensen KRL Gromov K Mohaddes M Malchau H Troelsen A
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Vitamin E-doped cross-linked polyethylene (VEPE) has encouraged the use of larger heads in thinner liners in total hip arthroplasty (THA). However, there are concerns about wear and mechanical failure of the thin liner, especially when metal heads are used. The aim of this randomized controlled trial was to investigate if the use of a large metal head in a thin VEPE liner would increase polyethylene wear compared with a standard 32-mm metal head and to compare periacetabular radiolucencies and patient-reported outcomes in THA.

96 candidates for uncemented THA were randomly allocated to either the largest possible metal head (36–44 mm) that could be fitted in the thinnest available VEPE liner (intervention group) or a standard 32-mm metal head (control group). The primary outcome was proximal head penetration (PHP) measured with model-based radiostereometric analysis (RSA). Secondary outcomes were periacetabular radiolucencies and patient-reported outcomes. The mid-term results of the trial at 5 years are presented.

Median total PHP (interquartile range) was -0.04 mm (−0.12 to 0.02) in the intervention group and -0.03 mm (=0.14 to 0.05) in the control group (p=0.691). The rates of periacetabular radiolucencies were 1/44 and 4/42 (p=0.197), respectively. Patient-reported hip function and health-related quality of life did not differ between the groups, but participants in the intervention group reported a higher level of activity (median UCLA rank 7 vs 6, p=0.020). There were 5 revisions caused by dislocations (2), periprosthetic fracture (1), stem subsidence (1), or iliopsoas impingement (1).

Large metal heads in thin VEPE liners did not increase liner wear and were not associated with liner failure 5 years after THA.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 80 - 80
19 Aug 2024
Malchau H
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The painful hip without obvious clinical or radiographic signs of complications is a well-known scenario for surgeons. The clinical tools we have access to currently lack a dynamic test for detecting early signs of motion between implant and bone.

A new software, Sectra IMA, has a potential to facilitate diagnosis of early implant loosening by analysis of paired CT exams. In clinical practise the two scans are acquired by endpoint of a possible motion, “a provocation CT”, for example maximal external and internal rotation in a CT hip examination. 20 years of research by Olivecrona and Weidenhielm is the scientific background for the technique. Early results are presented by Sandberg et al 2022.

To further validate and create clinical evidence more extensive clinical studies is needed. A proposal for a multicentric, global clinical study will be presented for further discussion.

A new technique for diagnosis of acetabular cup loosening using computed tomography: preliminary experience in 10 patients. Henrik Olivecrona, Lotta Olivecrona, Lars Weidenhielm, Marilyn E Noz, Jocelyn Kardos, Gerald Q Maguire Jr, Michael P Zeleznik, Peter Aspelin. Acta Orthop. 2008 Jun;79(3):346-53. doi: 10.1080/17453670710015247.

Inducible displacement CT increases the diagnostic accuracy of aseptic loosening in primary total hip arthroplasty. Sandberg O, Carlsson S, Harbom E, Cappelen V, Tholén S, Olivecrona H, Wretenberg P. Acta Orthop. 2022 Oct 31;93:831-836. doi: 10.2340/17453674.2022.5240.PMID: 36314542


The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 435 - 441
1 May 2024
Angelomenos V Mohaddes M Kärrholm J Malchau H Shareghi B Itayem R

Aims

Refobacin Bone Cement R and Palacos R + G bone cement were introduced to replace the original cement Refobacin Palacos R in 2005. Both cements were assumed to behave in a biomechanically similar fashion to the original cement. The primary aim of this study was to compare the migration of a polished triple-tapered femoral stem fixed with either Refobacin Bone Cement R or Palacos R + G bone cement. Repeated radiostereometric analysis was used to measure migration of the femoral head centre. The secondary aims were evaluation of cement mantle, stem positioning, and patient-reported outcome measures.

Methods

Overall, 75 patients were included in the study and 71 were available at two years postoperatively. Prior to surgery, they were randomized to one of the three combinations studied: Palacos cement with use of the Optivac mixing system, Refobacin with use of the Optivac system, and Refobacin with use of the Optipac system. Cemented MS30 stems and cemented Exceed acetabular components were used in all hips. Postoperative radiographs were used to assess the quality of the cement mantle according to Barrack et al, and the position and migration of the femoral stem. Harris Hip Score, Oxford Hip Score, Forgotten Joint Score, and University of California, Los Angeles Activity Scale were collected.


The Bone & Joint Journal
Vol. 106-B, Issue 3 Supple A | Pages 31 - 37
1 Mar 2024
Bunyoz KI Tsikandylakis G Mortensen K Gromov K Mohaddes M Malchau H Troelsen A

Aims

In metal-on-polyethylene (MoP) total hip arthroplasty (THA), large metal femoral heads have been used to increase stability and reduce the risk of dislocation. The increased size of the femoral head can, however, lead to increased taper corrosion, with the release of metal ions and adverse reactions. The aim of this study was to investigate the relationship between the size of the femoral head and the levels of metal ions in the blood in these patients.

Methods

A total of 96 patients were enrolled at two centres and randomized to undergo MoP THA using either a 32 mm metal head or a femoral head of between 36 mm and 44 mm in size, being the largest possible to fit the thinnest available polyethylene insert. The levels of metal ions and patient-reported outcome measures (Oxford Hip Score, University of California, Los Angeles Activity Scale) were recorded at two and five years postoperatively.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_12 | Pages 34 - 34
23 Jun 2023
Bunyoz KI Tsikandylakis G Mortensen K Gromov K Mohaddes M Malchau H Troelsen A
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In metal-on-polyethylene (MoP) THA large femoral metal heads are designed to increase stability and to reduce dislocation risk. The increased head size could lead to increased taper corrosion with the release of metal ions and adverse reactions. Using blood ion measurements, we aimed to investigate the association between femoral head size and metal-ion release after MoP THA.

96 patients were enrolled at two centers and randomized to receive either a 32-mm metal head or a 36–44 mm metal head (the largest possible fitting the thinnest available polyethylene insert). Blood metal ions and PROMs (OHS, UCLA) were measured at two- and five-year follow-ups.

Both 2- and 5-year median chrome, cobalt, and titanium levels were below taper corrosion indicative ion levels. At 5 years, median chrome, cobalt, and titanium levels were 0.5 μg/L (0.50–0.62), 0.24 μg/L (0.18–0.30), and 1.16 μg/L (1.0–1.68) for the 32-mm group, and 0.5 μg/L (0.5–0.54), 0.23 μg/L (0.17–0.39), and 1.30 μg/L (1–2.05) for the 36–44 mm group, with no difference between groups (p=0.825, p=1.000, p=0.558). At 2 years, 7 (32-mm) versus 4 (36–44-mm) patients had elevated ions. At 5 years, 6 (32-mm) versus 7 (36–44-mm) patients had elevated ions. There was no difference in either OHS (p=0.665) or UCLA (p=0.831) between patients with or without elevated blood metal ions.

5 years after the insertion of MoP THAs, we found no differences in the blood metal ion levels between 32 mm heads and 36–44 mm heads and no corrosion-related revisions. As taper corrosion can debut after 5 years, there is still a need for long-term follow-up studies on the association between head size and corrosion in MoP THA.


The Bone & Joint Journal
Vol. 104-B, Issue 7 | Pages 765 - 766
1 Jul 2022
Haddad FS Malchau H


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_14 | Pages 36 - 36
1 Nov 2021
Malchau KS Tillander J Zaborowska M Hoffman M Lasa I Thomsen P Malchau H Rolfson O Trobos M
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Periprosthetic joint infections (PJI) are challenging complications following arthroplasty. Staphylococci are a frequent cause of PJI and known biofilm producers.

Reoperations for PJI of the hip or knee between 2012 and 2015 performed at Sahlgrenska University Hospital were identified. Medical records were reviewed, and clinical parameters recorded for patients whose intraoperative bacterial isolates had been stored at the clinical laboratory. Staphylococcal strains isolated from reoperations due to first-time PJI were characterised by their ability to form biofilms using the microtiter plate test.

The study group included 49 patients (70 bacterial strains) from first-time PJI, whereof 24 (49%) patients had recurrent infection. Strong biofilm production was significantly associated with recurrent infection. Patients infected with strong biofilm producers had a five-fold increased risk for recurrent infection.

Strong biofilm production was significantly associated with increased antimicrobial resistance and PJI recurrence. This underscores the importance of determining biofilm production and susceptibility as part of routine diagnostics in PJI. Strong staphylococcal biofilm production may have implications on therapeutic choices and suggest more extensive surgery. Furthermore, despite the increased biofilm resistance to rifampicin, results from this study support its use in staphylococcal PJI.


The Bone & Joint Journal
Vol. 103-B, Issue 7 | Pages 1206 - 1214
1 Jul 2021
Tsikandylakis G Mortensen KRL Gromov K Mohaddes M Malchau H Troelsen A

Aims

We aimed to investigate if the use of the largest possible cobalt-chromium head articulating with polyethylene acetabular inserts would increase the in vivo wear rate in total hip arthroplasty.

Methods

In a single-blinded randomized controlled trial, 96 patients (43 females), at a median age of 63 years (interquartile range (IQR) 57 to 69), were allocated to receive either the largest possible modular femoral head (36 mm to 44 mm) in the thinnest possible insert or a standard 32 mm head. All patients received a vitamin E-doped cross-linked polyethylene insert and a cobalt-chromium head. The primary outcome was proximal head penetration measured with radiostereometric analysis (RSA) at two years. Secondary outcomes were volumetric wear, periacetabular radiolucencies, and patient-reported outcomes.


The Bone & Joint Journal
Vol. 102-B, Issue 10 | Pages 1303 - 1310
3 Oct 2020
Kjærgaard K Ding M Jensen C Bragdon C Malchau H Andreasen CM Ovesen O Hofbauer C Overgaard S

Aims

The most frequent indication for revision surgery in total hip arthroplasty (THA) is aseptic loosening. Aseptic loosening is associated with polyethylene liner wear, and wear may be reduced by using vitamin E-doped liners. The primary objective of this study was to compare proximal femoral head penetration into the liner between a) two cross-linked polyethylene (XLPE) liners (vitamin E-doped (vE-PE)) versus standard XLPE liners, and b) two modular femoral head diameters (32 mm and 36 mm).

Methods

Patients scheduled for a THA were randomized to receive a vE-PE or XLPE liner with a 32 mm or 36 mm metal head (four intervention groups in a 2 × 2 factorial design). Head penetration and acetabular component migration were measured using radiostereometric analysis at baseline, three, 12, 24, and 60 months postoperatively. The Harris Hip Score, University of California, Los Angeles (UCLA) Activity Score, EuroQol five-dimension questionnaire (EQ-5D), and 36-Item Short-Form Health Survey questionnaire (SF-36) were assessed at baseline, three, 12, 36, and 60 months.


The Bone & Joint Journal
Vol. 102-B, Issue 7 Supple B | Pages 90 - 98
1 Jul 2020
Florissi I Galea VP Sauder N Colon Iban Y Heng M Ahmed FK Malchau H Bragdon CR

Aims

The primary aim of this paper was to outline the processes involved in building the Partners Arthroplasty Registry (PAR), established in April 2016 to capture baseline and outcome data for patients undergoing arthroplasty in a regional healthcare system. A secondary aim was to determine the quality of PAR’s data. A tertiary aim was to report preliminary findings from the registry and contributions to quality improvement initiatives and research up to March 2019.

Methods

Structured Query Language was used to obtain data relating to patients who underwent total hip or knee arthroplasty (THA and TKA) from the hospital network’s electronic medical record (EMR) system to be included in the PAR. Data were stored in a secure database and visualized in dashboards. Quality assurance of PAR data was performed by review of the medical records. Capture rate was determined by comparing two months of PAR data with operating room schedules. Linear and binary logistic regression models were constructed to determine if length of stay (LOS), discharge to a care home, and readmission rates improved between 2016 and 2019.


The Bone & Joint Journal
Vol. 102-B, Issue 6 | Pages 736 - 743
1 Jun 2020
Svensson K Rolfson O Mohaddes M Malchau H Erichsen Andersson A

Aims

To investigate the experience and emotional impact of prosthetic joint infection (PJI) on orthopaedic surgeons and identify holistic strategies to improve the management of PJI and protect surgeons’ wellbeing.

Methods

In total, 18 prosthetic joint surgeons in Sweden were recruited using a purposive sampling strategy. Content analysis was performed on transcripts of individual in-person interviews conducted between December 2017 and February 2018.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 55 - 63
1 Jan 2020
Hagberg K Ghassemi Jahani S Kulbacka-Ortiz K Thomsen P Malchau H Reinholdt C

Aims

The aim of this study was to describe implant and patient-reported outcome in patients with a unilateral transfemoral amputation (TFA) treated with a bone-anchored, transcutaneous prosthesis.

Methods

In this cohort study, all patients with a unilateral TFA treated with the Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) implant system in Sahlgrenska University Hospital, Gothenburg, Sweden, between January 1999 and December 2017 were included. The cohort comprised 111 patients (78 male (70%)), with a mean age 45 years (17 to 70). The main reason for amputation was trauma in 75 (68%) and tumours in 23 (21%). Patients answered the Questionnaire for Persons with Transfemoral Amputation (Q-TFA) before treatment and at two, five, seven, ten, and 15 years’ follow-up. A prosthetic activity grade was assigned to each patient at each timepoint. All mechanical complications, defined as fracture, bending, or wear to any part of the implant system resulting in removal or change, were recorded.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_12 | Pages 24 - 24
1 Oct 2019
Florissi IS Galea VP Rojanasopondist P Sauder N Iban YEC Malchau H Bragdon CR
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Introduction

This analysis aims to provide an update of the Level-IV Partners Arthroplasty Registry (PAR), a quality-improvement initiative and research data repository.

Methods

The Harris Joint Registry was founded in 1969 and has since expanded to become the Partners Arthroplasty Registry (PAR). Today, the PAR captures data on total hip and total knee arthroplasties conducted at seven hospitals in Massachusetts. Over time, data has been sourced through independent collection at a single hospital, retrospective sourcing through the Research Patient Data Registry (RPDR), and currently through the Enterprise Data Warehouse (EDW). Various statistical methods analyzed changing trends of care provided to patients across affiliated institutions. PROMs collected in the PAR are the PROMIS Physical Function and Global Health Short Forms, the HOOS and KOOS. The registry is an associate member of ISAR and will incorporate the international implant library.


The Bone & Joint Journal
Vol. 101-B, Issue 7 | Pages 758 - 759
1 Jul 2019
Galea VP Rojanasopondist P Laursen M Muratoglu OK Malchau H Bragdon C


The Bone & Joint Journal
Vol. 101-B, Issue 7 | Pages 760 - 767
1 Jul 2019
Galea VP Rojanasopondist P Laursen M Muratoglu OK Malchau H Bragdon C

Aims

Vitamin E-diffused, highly crosslinked polyethylene (VEPE) and porous titanium-coated (PTC) shells were introduced in total hip arthroplasty (THA) to reduce the risk of aseptic loosening. The purpose of this study was: 1) to compare the wear properties of VEPE to moderately crosslinked polyethylene; 2) to assess the stability of PTC shells; and 3) to report their clinical outcomes at seven years.

Patients and Methods

A total of 89 patients were enrolled into a prospective study. All patients received a PTC shell and were randomized to receive a VEPE liner (n = 44) or a moderately crosslinked polyethylene (ModXLPE) liner (n = 45). Radiostereometric analysis (RSA) was used to measure polyethylene wear and component migration. Differences in wear were assessed while adjusting for body mass index, activity level, acetabular inclination, anteversion, and head size. Plain radiographs were assessed for radiolucency and patient-reported outcome measures (PROMs) were administered at each follow-up.


The Bone & Joint Journal
Vol. 101-B, Issue 7 | Pages 768 - 778
1 Jul 2019
Galea VP Rojanasopondist P Ingelsrud LH Rubash HE Bragdon C Huddleston III JI Malchau H Troelsen A

Aims

The primary aim of this study was to quantify the improvement in patient-reported outcome measures (PROMs) following total hip arthroplasty (THA), as well as the extent of any deterioration through the seven-year follow-up. The secondary aim was to identify predictors of PROM improvement and deterioration.

Patients and Methods

A total of 976 patients were enrolled into a prospective, international, multicentre study. Patients completed a battery of PROMs prior to THA, at three months post-THA, and at one, three, five, and seven-years post-THA. The Harris Hip Score (HHS), the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS), the SF-36 Mental Component Summary (MCS), and the EuroQol five-dimension three-level (EQ-5D) index were the primary outcomes. Longitudinal changes in each PROM were investigated by piece-wise linear mixed effects models. Clinically significant deterioration was defined for each patient as a decrease of one half of a standard deviation (group baseline).


The Bone & Joint Journal
Vol. 100-B, Issue 12 | Pages 1592 - 1599
1 Dec 2018
Galea VP Connelly JW Shareghi B Kärrholm J Sköldenberg O Salemyr M Laursen MB Muratoglu O Bragdon C Malchau H

Aims

The primary aim of this study was to compare the wear properties of vitamin E-diffused, highly crosslinked polyethylene (VEPE) and one formulation of moderately crosslinked and mechanically annealed ultra-high molecular weight polyethylene (ModXLPE) in patients five years after primary total hip arthroplasty (THA). The secondary aim was to assess the clinical results of patients treated with VEPE by evaluating patient-reported outcome measures (PROMs), radiological evidence of fixation, and the incidence of mechanical failure.

Patients and Methods

A total of 208 patients (221 THAs) from four international centres were recruited into a prospective study involving radiostereometric analysis (RSA) and the assessment of clinical outcomes. A total of 193 hips (87%) were reviewed at the five-year follow-up. Of these, 136 (70%) received VEPE (vs ModXLPE) liners and 68 (35%) received ceramic (vs metal) femoral heads. PROMs and radiographs were collected preoperatively and at one, two, and five years postoperatively. In addition, RSA images were collected to measure PE wear postoperatively and at one, two, and five years after surgery.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_12 | Pages 20 - 20
1 Oct 2018
Galea V Connelly J Matuszak S Botros MA Rojanasopondist P Nielsen C Huddleston J Bragdon C Malchau H Troelsen A
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Introduction

The aim of this study was to evaluate the effects of posterior tibial slope (PTS) and posterior condylar offset (PCO) on patient-reported pain and function one year after TKA.

Methods

A total of 500 patients from 11 clinics in 6 countries were enrolled into a prospective, multicenter study. All patients were indicated for primary TKA for OA and received components from a single manufacturer. All liners were made from vitamin-E stabilized, highly crosslinked (95 kGy) polyethylene; 54.7% were posterior stabilized (PS) and the remaining were cruciate-retaining.

The Knee Injury and Osteoarthritis Outcome Score (KOOS) was administered at the one-year follow-up visit. The KOOS pain and activities in daily life (ADL) sub-scores were dichotomized and served as the primary outcomes. Dichotomization was done with the patient acceptable symptom state (PASS), defined by previous studies as the value of the PROM above which patients deem their state as acceptable (84.5 points for KOOS pain and 83.0 points for KOOS ADL).

Plain lateral radiographs were taken and assessed for PTS (Figure 1) and PCO (Figure 2). PTS was categorized as above (excessive flexion), within (ideal), or below (extension) the safe zone of 0° − 7° of flexion. PCO increases or decreases of greater than 3mm were compared against no change (≤ 3mm). Each of the two sagittal positioning metrics was tested against the KOOS pain and ADL PASS at one year.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_13 | Pages 48 - 48
1 Oct 2018
Galea VP Connelly JW Matuszak SJ Rojanasopondist P Bragdon CR Huddleston JI Rubash HE Malchau H
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Introduction

Within the field of arthroplasty, the use of patient-reported outcome measures (PROMs) is becoming increasingly ubiquitous in an effort to employ more patient-centered methods of evaluating success. PROMs may be used to assess general health, joint-specific pain or function, or mental health. General and joint-specific questionnaires are most often used in arthroplasty research, but the relationship between arthroplasty and mental health is less well understood. Furthermore, longitudinal reports of PROM changes after arthroplasty are lacking in the literature.

Our primary aim was to quantify the improvement in general, joint-specific, and mental health PROMs following total hip arthroplasty (THA) as well as the extent of any deterioration through the 7 years follow-up. Our secondary aim was to identify predictors of clinically significant PROM decline.

Methods

A total of 864 patients from 17 centers across 8 countries were enrolled into a prospective study. Patients were treated with components from a single manufacturer, which have been shown to be well-functioning in other studies.

Patients completed a battery of PROMs preoperatively, and at one, three, five, and seven years post-THA. Changes in PROMs between study visits were assessed via paired tests.

Postoperative trends for each PROM were determined for each subject by the slope of the best-fit line of the four postoperative data points. Significant PROM deterioration was defined as one literature-defined minimum clinically important difference over 5-years. Binary logistic regressions were used to identify independent predictors of significant decline in the EuroQol (EQ-5D) visual analogue scale (VAS) for Health State, 36-Item Short Form Survey (SF-36) physical composite summary (PCS), and SF-36 mental composite summary (MCS).


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_13 | Pages 46 - 46
1 Oct 2018
Matuszak SJ Galea VP Rojanasopondist P Connelly JW Bragdon CR Huddleston JI Malchau H
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Introduction

The goal of the current study was to determine if SES affects PROMs in patients treated with THA. Specifically, we sought to determine any potential differences between low and high SES patients in pre-surgical PROMs, post-surgical PROMs, and PROM improvement after surgery while controlling for any potential confounding demographic factors.

Methods

Patients were selected from a clinical registry at an urban tertiary academic medical center. All patients undergoing primary THA between January 1, 2000 and April 1, 2016 were eligible for this study. During this period, patients were asked to complete the Harris Hip Score (HHS), Euro-QoL 5 Dimension (EQ-5D), 0–10 Numerical Rating Scale (NRS) Pain, 0–10 NRS Satisfaction (only given postoperatively), the Charnley Classifier, and the University of California Los Angeles (UCLA) Activity Score.

To determine SES, patients were matched by zip code to corresponding median household income as reported by the United States Census Bureau. Patients were then dichotomized into low and high SES groups using 2016 median household income of $57,617 USD as a cutoff point.

Statistical differences between low and high SES patients were determined for demographic factors, preoperative PROMs, postoperative PROMs, and PROM change. Non-parametric variables were tested with the Mann Whitney U test and categorical variables were tested with the Chi squared test.

Multivariate models were created to determine if SES group was independently predictive of achieving a minimal clinically important improvement (MCII) in PROMs (18.0 for HHS, −2.0 for NRS Pain, and 0.92 for UCLA). As potential confounders, we tested body mass index (BMI), preoperative health state from EQ-5D visual analog scale (EQ VAS), age at surgery, preoperative Charnley class, sex, and time between PROMs.