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Bone & Joint Research
Vol. 13, Issue 5 | Pages 226 - 236
9 May 2024
Jürgens-Lahnstein JH Petersen ET Rytter S Madsen F Søballe K Stilling M

Aims

Micromotion of the polyethylene (PE) inlay may contribute to backside PE wear in addition to articulate wear of total knee arthroplasty (TKA). Using radiostereometric analysis (RSA) with tantalum beads in the PE inlay, we evaluated PE micromotion and its relationship to PE wear.

Methods

A total of 23 patients with a mean age of 83 years (77 to 91), were available from a RSA study on cemented TKA with Maxim tibial components (Zimmer Biomet). PE inlay migration, PE wear, tibial component migration, and the anatomical knee axis were evaluated on weightbearing stereoradiographs. PE inlay wear was measured as the deepest penetration of the femoral component into the PE inlay.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_17 | Pages 41 - 41
24 Nov 2023
Lilleøre JG Jørgensen A Knudsen M Hanberg P Öbrink-Hansen K Tøstesen S Søballe K Stilling M Bue M
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Background and aim

Implant-associated osteomyelitis is one of the most feared complications following orthopedic surgery. Although the risk is low it is crucial to achieve adequate antibiotic concentrations proximate to the implant for a sufficient amount of time to protect the implant surface and ensure tissue integration. The aim of this study was to assess steady-state piperacillin concentrations in the proximity of an orthopedic implant inserted in cancellous bone.

Method

Six female pigs received an intravenous bolus infusion of 4 g/0.5 g piperacillin/tazobactam over 30 min every 6 h. Steady state was assumed achieved in the third dosing interval (12–18 h). Microdialysis catheters were placed in a cannulated screw in the proximal tibial cancellous bone, in cancellous bone next to the screw, and in cancellous bone on the contralateral tibia. Dialysates were collected from time 12 to 18 h and plasma samples were collected as reference.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 148 - 148
4 Apr 2023
Jørgensen P Kaptein B Søballe K Jakobsen S Stilling M
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Dual mobility hip arthroplasty utilizes a freely rotating polyethylene liner to protect against dislocation. As liner motion has not been confirmed in vivo, we investigated the liner kinematics in vivo using dynamic radiostereometry.

16 patients with Anatomical Dual Mobility acetabular components were included. Markers were implanted in the liners using a drill guide. Static RSA recordings and patient reported outcome measures were obtained at post-op and 1-year follow-up. Dynamic RSA recordings were obtained at 1-year follow-up during a passive hip movement: abduction/external rotation, adduction/internal rotation (modified FABER-FADIR), to end-range and at 45° hip flexion. Liner- and neck movements were described as anteversion, inclination and rotation.

Liner movement during modified FABER-FADIR was detected in 12 of 16 patients. Median (range) absolute liner movements were: anteversion 10° (5–20), inclination 6° (2–12), and rotation 11° (5–48) relative to the cup. Median absolute changes in the resulting liner/neck angle (small articulation) was 28° (12–46) and liner/cup angle (larger articulation) was 6° (4–21). Static RSA showed changes in median (range) liner anteversion from 7° (-12–23) postoperatively to 10° (-3–16) at 1-year follow-up and inclination from 42 (35–66) postoperatively to 59 (46–80) at 1-year follow-up. Liner/neck contact was associated with high initial liner anteversion (p=0.01).

The polyethylene liner moves over time. One year after surgery the liner can move with or without liner/neck contact. The majority of movement is in the smaller articulation between head and liner.


The Bone & Joint Journal
Vol. 104-B, Issue 6 | Pages 647 - 656
1 Jun 2022
Knudsen MB Thillemann JK Jørgensen PB Jakobsen SS Daugaard H Søballe K Stilling M

Aims

BoneMaster is a thin electrochemically applied hydroxyapatite (HA) coating for orthopaedic implants that is quickly resorbed during osseointegration. Early stabilization is a surrogacy marker of good survival of femoral stems. The hypothesis of this study was that a BoneMaster coating yields a fast early and lasting fixation of stems.

Methods

A total of 53 patients were randomized to be treated using Bi-Metric cementless femoral stems with either only a porous titanium plasma-sprayed coating (P group) or a porous titanium plasma-sprayed coating with an additional BoneMaster coating (PBM group). The patients were examined with radiostereometry until five years after surgery.


Bone & Joint Research
Vol. 10, Issue 1 | Pages 60 - 67
1 Jan 2021
Bendtsen MAF Bue M Hanberg P Slater J Thomassen MB Hansen J Søballe K Öbrink-Hansen K Stilling M

Aims

Flucloxacillin is commonly administered intravenously for perioperative antimicrobial prophylaxis, while oral administration is typical for prophylaxis following smaller traumatic wounds. We assessed the time, for which the free flucloxacillin concentration was maintained above the minimum inhibitory concentration (fT > MIC) for methicillin-susceptible Staphylococcus aureus in soft and bone tissue, after intravenous and oral administration, using microdialysis in a porcine model.

Methods

A total of 16 pigs were randomly allocated to either intravenous (Group IV) or oral (Group PO) flucloxacillin 1 g every six hours during a 24-hour period. Microdialysis was used for sampling in cancellous and cortical bone, subcutaneous tissue, and the knee joint. In addition, plasma was sampled. The flucloxacillin fT > MIC was evaluated using a low MIC target (0.5 μg/ml) and a high MIC target (2.0 μg/ml).


Bone & Joint Research
Vol. 8, Issue 7 | Pages 313 - 322
1 Jul 2019
Hanberg P Lund A Søballe K Bue M

Objectives

Meropenem may be an important drug in the treatment of open tibial fractures and chronic osteomyelitis. Therefore, the objective of this study was to describe meropenem pharmacokinetics in plasma, subcutaneous adipose tissue (SCT), and cancellous bone using microdialysis in a porcine model.

Methods

Six female pigs were assigned to receive 1000 mg of meropenem intravenously over five minutes. Measurements of meropenem were obtained from plasma, SCT, and cancellous bone for eight hours thereafter. Microdialysis was applied for sampling in solid tissues. The meropenem concentrations were determined using ultra-high-performance liquid chromatography.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_17 | Pages 69 - 69
1 Dec 2018
Bue M Hanberg P Tøttrup M Thomassen M Sorensen HB Thillemann TM Andersson TL Søballe K
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Aims

Vancomycin may be an important drug for intravenous perioperative antimicrobial prophylaxis in spine surgery. We assessed single-dose vancomycin intervertebral disc, vertebral cancellous bone, and subcutaneous adipose tissue concentrations using microdialysis in a pig model.

Methods

8 female pigs received 1,000 mg of vancomycin intravenously as a single dose over 100 minutes. Microdialysis probes were placed in the C3-C4 intervertebral disc, C3 vertebral cancellous bone, and subcutaneous adipose tissue, and vancomycin concentrations were obtained over 8 hours. Venous blood samples were obtained as reference.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_17 | Pages 45 - 45
1 Dec 2018
Bue M Hanberg P Koch J Jensen LK Lundorff M Aalbæk B Jensen HE Søballe K Tøttrup M
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Aim

The increasing incidence of orthopaedic methicillin-resistant Staphylococcus aureus (MRSA) infections represents a significant therapeutic challenge. Being effective against MRSA, the role of vancomycin may become more important in the orthopaedic setting in the years to come. Nonetheless, vancomycin bone and soft tissue penetration during infection remains unclear. We assessed the effect of a traumatically induced, implant-associated acute osteomyelitis on vancomycin bone penetration in a porcine model.

Method

In eight pigs, implant-associated osteomyelitis was induced on day 0, using a Staphylococcus aureus strain. Following administration of 1,000 mg of vancomycin on day 5, vancomycin concentrations were obtained with microdialysis for eight hours in the implant bone cavity, in cancellous bone adjacent to the implant cavity, in subcutaneous adipose tissue (SCT) adjacent to the implant cavity, and in healthy cancellous bone and healthy SCT in the contralateral leg. Venous blood samples were also obtained. The extent of infection and inflammation was evaluated by post-mortem computed tomography scans, C-reactive protein serum levels and cultures of blood and swabs.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_4 | Pages 64 - 64
1 Apr 2018
Jacobsen JS Hölmich P Thorborg K Bolvig L Jakobsen SS Søballe K Mechlenburg I
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Introduction

Intra-articular injury has been described as primary cause of pain in hip dysplasia. At this point it is unknown whether external muscle-tendon related pain coexists with intra-articular pathology.

The primary aim was to identify muscle-tendon related pain in 100 dysplasia patients. The secondary aim was to test if muscle-tendon related pain is linearly associated to self-reported hip disability and muscle strength in patient with hip dysplasia.

Materials and methods

One hundred patients (17 men) with a mean age of 29 years (SD 9) were included. Clinical entity approach was carried out to identify muscle-tendon related pain. Muscle strength was assessed with a handheld dynamometer and self-reported hip disability was recorded with the Copenhagen Hip and Groin Outcome Score (HAGOS).


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_1 | Pages 88 - 88
1 Jan 2018
Søballe K Troelsen A Andreasen C
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The goal of periacetabular osteotomy (PAO) is to delay or prevent osteoarthritic development in dysplastic hips. However, it is unclear whether the surgical goals are achieved and if so in which patients. This information is essential to select appropriate patients for a durable PAO that achieves its goals.

We therefore (1) determined hip survival rates; (2) determined how many preserved hips were functionally successful after PAO; and (3) identified demographic, clinical, and radiographic factors predicting failure after PAO.

We reviewed 316 patients (401 hips) who had PAO. We evaluated radiographic parameters and obtained WOMAC scores. Through inquiry to the National Registry of Patients, we identified conversions to THA. Risk factors for conversion to THA were assessed. Mean followup was 8 years (range, 4–12 years).

We conclude that PAO can be performed with a good outcome at medium to long term follow-up, suggesting that it may be applied by experienced surgeons with satisfactory results. To further improve the outcome, focus should be on the potential negative influence of parameters that are easily assessed, such as the patients age (>45) preoperative grade of osteoarthritis, incongruency, and severe acetabular dysplasia. Perioperatively, the surgeon should attempt to achieve hip congruence and a CE angle between 30° to 40° to improve the durability of PAO.

Level II, prognostic study.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_22 | Pages 62 - 62
1 Dec 2017
Hanberg PE Bue M Sørensen HB Søballe K Tøttrup M
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Aim

Pyogenic spondylodiscitis is associated with prolonged antimicrobial therapy and high relapse rates. Nevertheless, tissue pharmacokinetic studies of relevant antimicrobials in both prophylactic and therapeutic situations are still sparse. Previous approaches based on bone biopsy and discectomy exhibit important methodological limitations. The objective of this study was therefore to assess the concentration of cefuroxime in intervertebral disc (IVD), vertebral body cancellous bone, subcutaneous adipose tissue (SCT) and plasma pharmacokinetics after single dose administration by use of microdialysis (MD) in a large animal model.

Method

Ten female pigs were assigned to receive 1,500 mg of cefuroxime intravenously over 15 min. Measurements of cefuroxime were obtained from plasma, SCT, the vertebral cancellous bone and the IVD for 8 hours thereafter. MD was applied for sampling in solid tissues. The cefuroxime concentration in both the MD and plasma samples was determined using ultra-high performance liquid chromatography.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_22 | Pages 74 - 74
1 Dec 2017
Bue M Tøttrup M Hanberg P Langhoff O Sorensen HB Thillemann TM Andersson TL Søballe K
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Aim

The incidence of orthopaedic methicillin-resistant staphylococcus aureus infections is increasing. Vancomycin may therefore play an increasingly important role in orthopaedic perioperative antimicrobial prophylaxis. Adequate antimicrobial concentrations at target site is essential for prevention of orthopaedic infections. Current studies investigating perioperative bone and soft tissue concentrations of vancomycin are sparse and challenged by a lack of appropriate methods. The aim of this study was therefore to assess the concentration of vancomycin in plasma, subcutaneous tissue and bone after single dose administration using microdialysis (MD) in patients undergoing total knee replacement.

Method

1,000 mg of vancomycin was postoperatively administered intravenously over 100 minutes to 10 male patients undergoing primary total knee replacement. Vancomycin concentrations in plasma, subcutaneous tissue (SCT), cancellous and cortical bone were measured the following 8 hours. MD was applied for sampling in solid tissues. The vancomycin concentration in MD-samples was determined using ultra-high performance liquid chromatography, whilst the free plasma concentration was determined using a chemistry analyzer*.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_22 | Pages 95 - 95
1 Dec 2017
Falstie-Jensen T Daugaard H Lange J Ovesen J Søballe K
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Background

Periprostetic joint infections (PJI) are often difficult to diagnose, to treat and often leave the patient with severe impaired function. The presence of low virulent bacteria is frequently discovered in apparent aseptic revisions of shoulder arthroplasties and pose a challenge to diagnose preoperatively.

Dual Isotope In111 Leucocyte/ Tc99 Bone Marrow SPECT CT scan (L/BMS) is considered the radionuclide gold standard in preoperative diagnosing PJI with reported high specificity and sensitivity in hip and knee arthroplasties.

Unfortunately, it is labour-intensive and expensive to perform and documentation using L/BMS on shoulder arthroplasties lack.

Aim

To investigate if L/BMS succeeds in detecting shoulder PJI compared to tissue cultures obtained perioperatively.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_22 | Pages 89 - 89
1 Dec 2017
Lange J Troelsen A Solgaard S Ørsnes T Otte K Nielsen PT Lamm M Krarup N Mikkelsen S Zawadski A Søballe K
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Aim

Our aim was to evaluate cementless one-stage revision in chronic periprosthetic hip joint infection.

Method and patients

The study was performed as a multicentre, proof-of-concept, observational study with prospective data collection. Inclusion of patients with a chronic periprosthetic hip joint infection (PJI) were followed by protocolled surgical treatment (cementless one-stage revision - the CORIHA protocol) at one of 8 participating departments of orthopaedic surgery between 2009 – 2014, and the patients enrolled in a 2-year follow-up program. A PJI were diagnosed based on adopted criteria from McPherson and Zimmerli. At the time of initiation of the study in 2009, the collaborating departments performed approximately one-fourth of all nationwide primary HJR and more than one-third of all revisions.

In total 56 PJI patients with a median age of 72 years and a median pre-operative ASA score of 2 met the established eligibility criteria and accepted to participate; 31 (55%) were males.

The cohort had a mean follow-up time of 4.0 years, with all patients followed for minimum 2 years.

The primary outcome were relapse described as re-revision due to infection (regardless of considered as a relapse or new infection). This was evaluated by competing risk analysis (competing risks: aseptic revisions and death).

Secondary, all-cause mortality was evaluated by survival analysis.

The study was approved by the local Committees on Biomedical Research Ethics.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_23 | Pages 77 - 77
1 Dec 2016
Tøttrup M Bue M Koch J Jensen LK Hanberg P Aalbæk B Fuursted K Jensen HE Søballe K
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Aim

A reason for treatment failure, in cases of periprosthetic bone infections and osteomyelitis, may be incomplete or heterogeneous tissue distribution of antimicrobials to the affected bone. Decreased bioavailability has been demonstrated in healthy bones but never in pathological bone tissue. Therefore, the aim was to obtain pharmacokinetic parameters of cefuroxime in infected bone tissue by means of microdialysis in a porcine model of implant associated osteomyelitis

Method

An implant cavity of 4 mm in diameter was drilled 25 mm into the right tibial bone of ten pigs (30 kg/BW). Subsequently, a small steel implant (K-wire 2 × 2 mm) and 104 CFU of Staphylococcus aureus was inserted and injected into the implant cavity. Five days after inoculation, two additional drill holes of 2 × 25 mm were drilled into the trabecular bone tissue adjacent to the implant cavity and into the left uninfected tibia. After intravenous administration of 1500 mg of cefuroxime, the concentration was measured in plasma and in the three tibial drill holes for 8 hours. All measurements were performed with microdialysis. Post mortem, the presence of bone infection was assessed by computed tomography (CT) scans and cultures of swabs.


The Bone & Joint Journal
Vol. 98-B, Issue 11 | Pages 1554 - 1562
1 Nov 2016
Martinkevich P Rahbek O Stilling M Pedersen LK Gottliebsen M Søballe K Møller-Madsen B

Aims

To compare the structural durability of hydroxyapatite-tricalcium phosphate (HATCP) to autologous iliac crest bone graft in calcaneal lengthening osteotomy (CLO) for pes planovalgus in childhood.

Patients and Methods

We present the interim results of ten patients (HATCP, n = 6 and autograft, n = 5) with a mean age of 11.5 years (8.2 to 14.2) from a randomised controlled non-inferiority trial with six months follow-up. The primary outcome was the stability of the osteotomy as measured by radiostereometric analysis. A non-inferiority margin of ≤ 2 mm osteotomy compression was set.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_15 | Pages 7 - 7
1 Dec 2015
Lange J Pedersen A Troelsen A Søballe K
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There is an apparent need for easily accessible research data on Periprosthetic hip joint infections (PJI)(1). Administrative discharge registers could be a valuable single-sources for this purpose, and studies originating from such registers have been published(2–4). However, the quality of routinely collected data for administrative purposes may be questionable for use in epidemiological research. The aim of this study was to estimate the positive predictive value of the International Classification of Disease 10th revision (ICD-10) periprosthetic hip joint infection diagnose code T84.5.

The study was performed as a cross-sectional study on data extracted from the Danish National Patient Register. Patients with a registration of performed surgical treatment for hip PJI were identified via the ICD-10 code T84.5 (Infection and inflammatory reaction due to internal joint prosthesis) in association with hip-joint associated surgical procedure codes. Medical records of the identified patients (n=283) were verified for the existence of a periprosthetic hip joint infection. Positive predictive values with 95% confidence intervals (95% CI) were calculated.

A T84.5 diagnosis code irrespective of the associated surgical procedure code had a positive predictive value of 85 % (95% CI: 80–89). Stratified to T84.5 in combination with an infection-specific surgical procedure code the positive predictive value increased to 86% (95% CI: 80–91), and in combination with a noninfection-specific surgical procedure code decreased to 82% (95% CI: 72–89).

This study is the first to evaluate the only discharge diagnose code of prosthesis-related infection in an administrative discharge register. It is apparent, that codes in administrative discharge registers are prone to misclassification on an administrative level, either by wrongful coding by the physician or administrative personal in the registration process. Misclassification must be expected and taken into consideration when using single-source administrative discharge registers for epidemiological research on periprosthetic hip joint infection. We believe that the periprosthetic hip joint infection diagnose code can be of use in single-source register based studies, but preferably should be used in combination with alternate data sources to ensure higher validity(5)

This study is funded in part by the Lundbeck foundation Centre for Fast-track Hip and Knee Surgery, Denmark.


Bone & Joint Research
Vol. 4, Issue 5 | Pages 78 - 83
1 May 2015
Martinkevich P Rahbek O Møller-Madsen B Søballe K Stilling M

Objectives

Lengthening osteotomies of the calcaneus in children are in general grafted with bone from the iliac crest. Artificial bone grafts have been introduced, however, their structural and clinical durability has not been documented. Radiostereometric analysis (RSA) is a very accurate and precise method for measurements of rigid body movements including the evaluation of joint implant and fracture stability, however, RSA has not previously been used in clinical studies of calcaneal osteotomies. We assessed the precision of RSA as a measurement tool in a lateral calcaneal lengthening osteotomy (LCLO).

Methods

LCLO was performed in six fixed adult cadaver feet. Tantalum markers were inserted on each side of the osteotomy and in the cuboideum. Lengthening was done with a plexiglas wedge. A total of 24 radiological double examinations were obtained. Two feet were excluded due to loose and poorly dispersed markers. Precision was assessed as systematic bias and 95% repeatability limits.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 140 - 140
1 Jul 2014
Hjorth M Søballe K Jakobsen S Lorenzen N Mechlenburg I Stilling M
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Summary

Five year migration results of 49 large-head metal-metal (MoM) total hip arthroplasties show good implant stability and no association between implant migration and metal-ions levels, stem and cup position, or femoral bone mineral density.

Introduction

The failure mechanism of metal-metal (MoM) total hip arthroplasty has been related to metal wear-debris and pseudotumor, but it is unknown whether implant fixation is affected by metal wear-debris.


Bone & Joint Research
Vol. 1, Issue 8 | Pages 180 - 191
1 Aug 2012
Stilling M Kold S de Raedt S Andersen NT Rahbek O Søballe K

Objectives

The accuracy and precision of two new methods of model-based radiostereometric analysis (RSA) were hypothesised to be superior to a plain radiograph method in the assessment of polyethylene (PE) wear.

Methods

A phantom device was constructed to simulate three-dimensional (3D) PE wear. Images were obtained consecutively for each simulated wear position for each modality. Three commercially available packages were evaluated: model-based RSA using laser-scanned cup models (MB-RSA), model-based RSA using computer-generated elementary geometrical shape models (EGS-RSA), and PolyWare. Precision (95% repeatability limits) and accuracy (Root Mean Square Errors) for two-dimensional (2D) and 3D wear measurements were assessed.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 29 - 29
1 Mar 2009
Troelsen A Elmengaard B Søballe K
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Introduction: Minimal invasive surgery (MIS) seems to be part of future orthopaedic solutions. Currently, most approaches for the Bernese periacetabular osteotomy (PAO) are characterized by relatively extensive incisions, dissection and detachment of muscles. We have developed a new MIS approach for the Bernese PAO. The purposes were to reduce patient morbidity and to improve the cosmetic result following surgery without negatively influencing the achieved reorientation of the acetabular articular surface. In this study we present the surgical technique, results and compare them to the ilioinguinal (II) approach.

Methods: The new MIS technique is a trans-sartorial approach using a three inch skin incision. Previously the II approach was used. From 1999–2006 a total of 215 patients with acetabular dysplasia were operated by the same surgeon in two successive time periods with the II (97) and the trans-sartorial (118) approaches. No supplemental surgery was performed. The two approaches are retrospectively compared regarding perioperative measures, transfusion requirements, complications and the achieved reorientation of the acetabular articular surface. Data are compared by Kruskal-Wallis Test and are presented as median and interquartile range.

Results: The trans-sartorial approach significantly reduced days of admission (8 days (7–9) vs. 10 days (8–13), p< 0.0001), duration of surgery (70 min (60–75) vs. 100 min (82.5–120), p< 0.0001), perioperative blood loss (200ml (150–350) vs. 450ml (325–700), p< 0.0001) and the percentage of patients receiving blood transfusion (18.6 % vs. 3.4%). Of severe neurovascular, infectious and technical complications none occurred in the trans-sartorial group and 3 cases of arterial thrombosis were seen in the II group. The achieved reorientation measured by the CE-angle postoperatively had median values of 31° (25–36) in the II group and 33° (29–36) in the trans-sartorial group, p=0.016. The postoperative AI-angles were 10° (2–14) and 3° (0–7) in the II and trans-sartorial groups respectively, p< 0.0001.

Discussion: Our shift to the trans-sartorial approach was rewarding as the duration of surgery, perioperative blood loss and transfusion requirements were reduced. The new MIS technique is safe and improves the cosmetic result without negative influence on the achieved reorientation of the acetabular articular surface.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 172 - 172
1 Mar 2009
Elmengaard B Baas J Bechtold J Jakobsen T Søballe K
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Introduction: Revision hip implants have poorer clinical outcome than primary implants. The fixation of the implants is often compromised by the formation of an endosteal sclerotic bone rim during the process of aseptic loosening. The cracking procedure is a bone sparing, low energy surgical technique which produces a controlled local perforation of the sclerotic bone rim. In previous studies, we showed that fixation of revision implants significantly improved by the cracking technique for both titanium (Ti) and hydroxyapatite (HA) coated implants (1). In this study we compared the cracking technique with the common technique of reaming, which completely removes the sclerotic bone rim.

Methods: A paired animal study (n=10), in which revision cavities was created by 20 micromotion implant systems inserted in both knees. Micromotion was 0.5mm per gait cycle. After 8 weeks revision surgery was performed.

Crack revision: The splined crack tool was introduced over the implant piston with firm axial hammer blows. This producing controlled cracking and local perforation of the sclerotic endosteal rim. The tool is a 6.0 mm cylinder fitted with axially spaced 1.1 mm pointed splines (8.2 mm outer diameter).

Reaming revision: A flat bottomed reamer was inserted over the implant piston using one rotation per second. The outer diameter was 8.2 mm in order to remove the sclerotic bone rim. Stable revision Ti implants was inserted. Observation period was 4 weeks. Mechanical push-out tests were performed. Students’ paired t-test was used. Data presented as mean and SEM.

Results: Shear strength was markedly higher with the cracking procedure 1.33± 0.3MPa vs. 0.34 ± 0.2 MPa (p< 0.05). Similar results was seen for Stiffness 6.7± 2.0 vs. 1.6 ± 0.9 (p< 0.05) in favor of the cracking procedure. A non-significant increase was seen in energy absorption 170± 47 vs. 50± 29 (p=0.07).

Discussion: The cracking procedure improves the mechanical fixation of Ti revision implants compared to a reaming procedure. Shear strength and stiffness was consistently higher for all implant pairs. We have previously shown that the sclerotic bone rim is a barrier for bone ingrowth and that implants inserted with an intact sclerotic bone rim will have a poor biomechanical fixation. Additionally, revision implants inserted with the cracking technique obtained a mechanical fixation comparable to primary implants. Reaming procedures are often used in hip revision surgery. However, as loss of bone stock is a common feature of revision cavities, the reaming procedure may not always be an optimal preparation method of the bone. Excessive removal of bone by reaming may compromise the long term implant stability or increase the risk of peri-implant fractures. The cracking technique may be an alternative or supplemental procedure to reaming.


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 1 | Pages 121 - 126
1 Jan 2007
Jensen TB Overgaard S Lind M Rahbek O Bünger C Søballe K

Impacted bone allograft is often used in revision joint replacement. Hydroxyapatite granules have been suggested as a substitute or to enhance morcellised bone allograft. We hypothesised that adding osteogenic protein-1 to a composite of bone allograft and non-resorbable hydroxyapatite granules (ProOsteon) would improve the incorporation of bone and implant fixation. We also compared the response to using ProOsteon alone against bone allograft used in isolation. We implanted two non-weight-bearing hydroxyapatite-coated implants into each proximal humerus of six dogs, with each implant surrounded by a concentric 3 mm gap. These gaps were randomly allocated to four different procedures in each dog: 1) bone allograft used on its own; 2) ProOsteon used on its own; 3) allograft and ProOsteon used together; or 4) allograft and ProOsteon with the addition of osteogenic protein-1.

After three weeks osteogenic protein-1 increased bone formation and the energy absorption of implants grafted with allograft and ProOsteon. A composite of allograft, ProOsteon and osteogenic protein-1 was comparable, but not superior to, allograft used on its own.

ProOsteon alone cannot be recommended as a substitute for allograft around non-cemented implants, but should be used to extend the volume of the graft, preferably with the addition of a growth factor.


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 10 | Pages 1303 - 1308
1 Oct 2006
Johnsen SP Sørensen HT Lucht U Søballe K Overgaard S Pedersen AB

We examined the association between patient-related factors and the risk of initial, short- and long-term implant failure after primary total hip replacement. We used data from the Danish Hip Arthroplasty Registry between 1 January 1995 and 31 December 2002, which gave us a total of 36 984 patients. Separate analyses were carried out for three follow-up periods: 0 to 30 days, 31 days to six months (short term), and six months to 8.6 years after primary total hip replacement (long term). The outcome measure was defined as time to failure, which included re-operation with open surgery for any reason.

Male gender and a high Charlson co-morbidity index score were strongly predictive for failure, irrespective of the period of follow-up. Age and diagnosis at primary total hip replacement were identified as time-dependent predictive factors of failure. During the first 30 days after primary total hip replacement, an age of 80 years or more and hip replacement undertaken as a sequela of trauma, for avascular necrosis or paediatric conditions, were associated with an increased risk of failure. However, during six months to 8.6 years after surgery, being less than 60 years old was associated with an increased risk of failure, whereas none of the diagnoses for primary total hip replacement appeared to be independent predictors.


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 4 | Pages 471 - 477
1 Apr 2005
Jacobsen S Sonne-Holm S Søballe K Gebuhr P Lund B

In a longitudinal case-control study, we followed 81 subjects with dysplasia of the hip and 136 control subjects without dysplasia for ten years assessing radiological evidence of degeneration of the hip at admission and follow-up. There were no cases of subluxation in the group with dysplasia. Neither subjects with dysplasia nor controls had radiological signs of ongoing degenerative disease at admission. The primary radiological discriminator of degeneration of the hip was a change in the minimum joint space width over time. There were no significant differences between these with dysplasia and controls in regard to age, body mass index or occupational exposure to daily repeated lifting at admission.

We found no significant differences in the reduction of the joint space width at follow-up between subjects with dysplasia and the control subjects nor in self-reported pain in the hip. The association of subluxation and/or associated acetabular labral tears with dysplasia of the hip may be a conditional factor for the development of premature osteoarthritis in mildly to moderately dysplastic hips.


The Journal of Bone & Joint Surgery British Volume
Vol. 84-B, Issue 6 | Pages 915 - 919
1 Aug 2002
Bechtold JE Kubic V Søballe K

We have investigated whether the presence of polyethylene (PE) alone is sufficient to cause an aggressive periprosthetic tissue response, or whether certain mechanical interface conditions can allow bone to grow while in the presence of PE. An experimental implant was loaded in the presence and absence of particulate PE under stable and unstable conditions.

Bone with a thin, discontinuous fibrous membrane formed in both groups of stable implants, either in the presence or absence of PE. By contrast, a continuous fibrous membrane consistently formed in both groups of unstable implants. The membrane consisted of loose fibrous connective tissue when PE was absent, and dense connective tissue with macrophages and a synovial lining when PE was present. In this model, if the interface was stable, the presence of PE was not sufficient to prevent the formation of bone or to produce a phagocytic tissue response. Only when the interface was unstable did a fibrous membrane form, and only then in the presence of PE.


The Journal of Bone & Joint Surgery British Volume
Vol. 83-B, Issue 3 | Pages 441 - 447
1 Apr 2001
Rahbek O Overgaard S Lind M Bendix K Bünger C Søballe K

We have studied the beneficial effects of a hydroxyapatite (HA) coating on the prevention of the migration of wear debris along the implant-bone interface. We implanted a loaded HA-coated implant and a non-coated grit-blasted titanium alloy (Ti) implant in each distal femoral condyle of eight Labrador dogs. The test implant was surrounded by a gap communicating with the joint space and allowing access of joint fluid to the implant-bone interface. We injected polyethylene (PE) particles into the right knee three weeks after surgery and repeated this weekly for the following five weeks. The left knee received sham injections. The animals were killed eight weeks after surgery. Specimens from the implant-bone interface were examined under plain and polarised light.

Only a few particles were found around HA-coated implants, but around Ti implants there was a large amount of particles. HA-coated implants had approximately 35% bone ingrowth, whereas Ti implants had virtually no bone ingrowth and were surrounded by a fibrous membrane.

Our findings suggest that HA coating of implants is able to inhibit peri-implant migration of PE particles by creating a seal of tightly-bonded bone on the surface of the implant.


The Journal of Bone & Joint Surgery British Volume
Vol. 82-B, Issue 2 | Pages 305 - 305
1 Mar 2000
OVERGAARD S SØBALLE K


The Journal of Bone & Joint Surgery British Volume
Vol. 81-B, Issue 4 | Pages 725 - 731
1 Jul 1999
Overgaard S Bromose U Lind M Bünger C Søballe K

We inserted two hydroxyapatite (HA)-coated implants with crystallinities of either 50% (HA-50%) or 75% (HA-75%) bilaterally into the medial femoral condyles of the knees of 16 dogs. The implants were allocated to two groups with implantation periods of 16 and 32 weeks. They were weight-bearing and subjected to controlled micromovement of 250 μm during each gait cycle. After 16 weeks, mechanical fixation of the HA-50% implants was increased threefold as compared with the HA-75% implants. After 32 weeks there was no difference between HA-50% and HA-75%. Fixation of HA-75% increased from 16 to 32 weeks whereas that of HA-50% was unchanged. HA-50% implants had 100% more bone ingrowth than HA-75% implants after 16 weeks. More HA coating was removed on HA-50% implants compared with HA-75% implants after both 16 and 32 weeks. No further loss of the HA coating was shown from 16 to 32 weeks.

Our study suggests that the crystallinity of the HA coating is an important factor in its bioactivity and resorption during weight-bearing conditions. Our findings suggest two phases of coating resorption, an initial rapid loss, followed by a slow loss. Resorbed HA coating was partly replaced by bone ingrowth, suggesting that implant fixation will be durable.


The Journal of Bone & Joint Surgery British Volume
Vol. 79-B, Issue 4 | Pages 654 - 659
1 Jul 1997
Overgaard S Søballe K Lind M Bünger C

The clinical use of hydroxyapatite (HA) coating is controversial especially in regard to the long-term performance of the coating and the effects of resorption. In each of 15 consenting patients we inserted two implants, coated with either HA or fluorapatite (FA) into the iliac crest. They were harvested at a mean of 13.6 ± 0.6 months after surgery.

Histological examination showed that bone ongrowth on the HA-coated implants was significantly greater (29%) than that on the FA-coated implants. When bone was present on the coating surface the HA coating was significantly thicker than the FA coating. When bone marrow was present, the HA coating was significantly thinner than the FA coating. The reduction in coating thickness when covered by bone or bone marrow was 23.1 ± 9.7 μm for HA and 5.1 ± 1.7 μm for FA (p < 0.01) suggesting that FA is more stable than HA against resorption by bone marrow.

The findings suggest that in man the osteoconductive properties of HA coating are superior to those of FA. Resorption rates for both coatings were approximately 20% of the coating thickness per year. Bone ongrowth appears to protect against resorption whereas bone marrow seems to accelerate resorption. No adverse reaction was seen in the surrounding bone.


The Journal of Bone & Joint Surgery British Volume
Vol. 78-B, Issue 5 | Pages 689 - 691
1 Sep 1996
Søballe K Overgaard S


The Journal of Bone & Joint Surgery British Volume
Vol. 78-B, Issue 3 | Pages 377 - 382
1 May 1996
Lind M Overgaard S Ongpipattanakul B Nguyen T Bünger C Søballe K

Bone growth into cementless prosthetic components is compromised by osteoporosis, by any gap between the implant and the bone, by micromotion, and after the revision of failed prostheses. Recombinant human transforming growth factor-β1 (rhTGF-β1) has recently been shown to be a potent stimulator of bone healing and bone formation in various models in vivo.

We have investigated the potential of rhTGF-β1, adsorbed on to weight-loaded tricalcium phosphate (TCP) coated implants, to enhance bone ongrowth and mechanical fixation. We inserted cylindrical grit-blasted titanium alloy implants bilaterally into the weight-bearing part of the medial femoral condyles of ten skeletally mature dogs. The implants were mounted on special devices which ensured stable weight-loading during each gait cycle. All implants were initially surrounded by a 0.75 mm gap and were coated with TCP ceramic.

Each animal received two implants, one with 0.3 μg rhTGF-β1 adsorbed on the ceramic surface and the other without growth factor. Histological analysis showed that bone ongrowth was significantly increased from 22 ± 5.6% bone-implant contact in the control group to 36 ± 2.9% in the rhTGF-β stimulated group, an increase of 59%. The volume of bone in the gap was increased by 16% in rhTGF-β1-stimulated TCP-coated implants, but this difference was not significant. Mechanical push-out tests showed no difference in fixation of the implant between the two groups. Our study suggests that rhTGF-β1 adsorbed on TCP-ceramic-coated implants can enhance bone ongrowth.