The primary outcome was investigating differences in wear, as measured by femoral head penetration, between cross-linked vitamin E-diffused polyethylene (vE-PE) and cross-linked polyethylene (XLPE) acetabular component liners and between 32 and 36 mm head sizes at the ten-year follow-up. Secondary outcomes included acetabular component migration and patient-reported outcome measures (PROMs) such as the EuroQol five-dimension questionnaire, 36-Item Short-Form Health Survey, Harris Hip Score, and University of California, Los Angeles Activity Scale (UCLA). A single-blinded, multi-arm, 2 × 2 factorial randomized controlled trial was undertaken. Patients were recruited between May 2009 and April 2011. Radiostereometric analyses (RSAs) were performed from baseline to ten years. Of the 220 eligible patients, 116 underwent randomization, and 82 remained at the ten-year follow-up. Eligible patients were randomized into one of four interventions: vE-PE acetabular liner with either 32 or 36 mm femoral head, and XLPE acetabular liner with either 32 or 36 mm femoral head. Parameters were otherwise identical except for acetabular liner material and femoral head size.Aims
Methods
Increased collection of patient-reported outcome measures (PROM) in registries enables international comparison of patient-centered outcomes after knee and hip replacement. We aimed to investigate 1) variations in PROM improvement, 2) the possible confounding factor of BMI, and 3) differences in comorbidity distributions between registries. Registries affiliated with the International Society of Arthroplasty Registries (ISAR) or OECD membership countries were invited to report aggregate EQ-5D, OKS, OHS, HOOS-PS and KOOS-PS values. Eligible patients underwent primary total, unilateral knee or hip replacement for osteoarthritis within three years and had completed PROMs preoperatively and either 6 or 12 months postoperatively, excluding patients with subsequent revisions. For each PROM cohort, Chi-square tests were performed for BMI distributions across registries and 12 predefined PROM strata (male/female, age 20-64/65-74/>75, high or low preoperative PROM scores). Comorbidity distributions were reported for available comorbidity indexes. Thirteen registries from 9 countries contributed data, n~130000 knee (range 140 to 79848) and n~113000 hip (range 137 to 85281). Mean EQ-5D index values (10 registries) ranged from 0.53 to 0.71 (knee) and 0.50 to 0.70 (hips) preoperatively and 0.78 to 0.85 (knee) and 0.83 to 0.87 (hip) postoperatively. Mean OKS (6 registries) ranged from 19.3 to 23.6 preoperatively and 36.2 to 41.2 postoperatively. Mean OHS (7 registries) ranged from 18.0 to 23.2 preoperatively and 39.8 to 44.2 postoperatively. Four registries reported KOOS-PS and three reported HOOS-PS. Proportions of patients with BMI >30 ranged from 35 to 62% (10 knee registries) and 16 to 43% (11 hip registries). For both knee and hip registries, distributions of patients across six BMI categories differed significantly among registries (p30 were for patients in the youngest age groups (20 to 64 and 65 to 74 years) with the lowest baseline scores. Additionally, females with lowest preoperative PROM scores had highest BMI. These findings were echoed for the OHS and OKS cohorts. Proportions of patients with ASA scores ≥3 ranged from 7 to 42% (9 knee registries) and 6 to 35% (8 hip registries). PROM-score improvement varies between international registries, which may be partially explained by differences in age, sex and preoperative scores. BMI and comorbidity may be relevant to adjust for.
Previous publications have suggested that the incidence of revisions due to infection after THA is increasing. We performed updated time-trend analyses of risk and timing of revision due to infection after primary THAs in the Nordic countries during the period 2004–2018. 569,463 primary THAs reported to the Nordic Arthroplasty Register Association from 2004 through 2018 were studied. We estimated adjusted hazard ratios (aHR) with 95% confidence interval by Cox regression with the first revision due to infection after primary THA as endpoint. The risk of revision was investigated. In addition, we explored changes in the time span from primary THA to revision due to infection.Aim
Methods
The aim of this study was to examine whether socioeconomic status (SES) is associated with a higher risk of infections following total hip arthroplasty (THA) at 30 and 90 days. We obtained individual-based information on SES markers (cohabitation, education, income, and savings) on 103,901 THA patients from Danish health registries between 1 January 1995 and 31 December 2017. The primary outcome measure was any hospital-treated infection (i.e. all infections). The secondary outcomes were further specified to specific hospital-treated infections (pneumonia, urinary tract infection, and periprosthetic joint infection). The primary timepoint was within 90 days. In addition, the outcomes were further evaluated within 30 days. We calculated the cumulative incidence, and used the pseudo-observation method and generalized linear regression to estimate adjusted risk ratios (RRs) with 95% confidence intervals (CIs) for each marker.Aims
Methods
The aim of this study was to assess the association of mortality and reoperation when comparing cemented and uncemented hemiarthroplasty (HA) in hip fracture patients aged over 65 years. This was a population-based cohort study on hip fracture patients using prospectively gathered data from several national registries in Denmark from 2004 to 2015 with up to five years follow-up. The primary outcome was mortality and the secondary outcome was reoperation. Hazard ratios (HRs) for mortality and subdistributional hazard ratios (sHRs) for reoperations are shown with 95% confidence intervals (CIs).Aims
Methods
Young patients are at increased risk of revision after primary THA (THA). The bearing surface may be of importance for the longevity of the joint. We aimed to compare the risk of revision of primary stemmed cementless THA with MoM and CoC with metal-on-highly-crosslinked-polyethylene (MoXLP) bearings in patients between 20–54 years. From NARA, we included 2,153 MoM, 4,120 CoC and 10,329 MoXLP THA operated between 1995 and 2017. Kaplan-Meier estimator was used for calculation of THA survivorship and Cox regression to estimate the hazard ratio (HR) of revision (95% CI) due to any and specific causes. MoXLP was reference. The median follow-up was 10.3 years for MoM, 6.6 years for CoC and 4.8 years for MoXLP. 15 years postoperatively the Kaplan-Meier survival estimates were 80% (78–83%) for MoM, 92% (91–93%) for CoC and 94% (93–95%) for MoXLP. The 0–2, 2–7 and 7–15 years adjusted HRs of revision by any cause were 1.4 (0.9–2.4), 3.2 (2.1–5.1) and 3.9 (1.9–7.9) for MoM and 1.1 (0.8–1.4), 1.0 (0.7–1.3) and 2.5 (1.3–4.8) for CoC bearings. After 7–15 years follow-up, the unadjusted HR of revision due to aseptic loosening was 5.4 (1.2–24) for MoM and 4.2 (0.9–20) for CoC THA. MoM and CoC had a 7–15 year adjusted HR of revision due to ‘other’ causes of 4.8 (1.6–14) and 2.1 (0.8–5.8). MoXLP bearings were associated with better survival than MoM and CoC bearings, mainly because of lower risk of revision due to aseptic loosening and ‘other’ causes.
Hip osteoarthritis (OA) is the leading cause for total hip arthroplasty (THA). Although, being considered as the surgery of the century up to 23% of the patients report long-term pain and deficits in physical function and muscle strength may persist after THA. Progressive resistance training (PRT) appear to improve several outcomes moderately in patients with hip OA. Current treatment selection is based on low-level evidence as no randomised controlled trials have compared THA to non-surgical treatment. The primary objective of this trial is to determine the effectiveness of THA followed by standard care compared to 12 weeks of supervised PRT followed by 12 weeks of optional unsupervised PRT, on changes in hip pain and function, in patients with severe hip OA after 6 months. This is a protocol for a multicentre, parallel-group, assessor blinded, randomised controlled superiority trial. Patients aged ≥50 years with clinical and radiographic hip OA found eligible for THA by an orthopaedic surgeon will be randomised to THA or PRT (allocation 1:1). The primary outcome will be change in patient-reported hip pain and function, measured using the Oxford Hip Score. Key secondary outcomes will be change in the Hip disability and Osteoarthritis Outcome Score subscales, University of California Los Angeles Activity Score, 40-meter fast-paced walk test, 30-second chair stand test, and number of serious adverse events.Introduction and Objective
Materials and Methods
The aim of this study is to compare the effectiveness and safety of thromboprophylactic treatments in patients undergoing primary total knee arthroplasty (TKA). Using nationwide medical registries, we identified patients with a primary TKA performed in Denmark between 1 January 2013 and 31 December 2018 who received thromboprophylactic treatment. We examined the 90-day risk of venous thromboembolism (VTE), major bleeding, and all-cause mortality following surgery. We used a Cox regression model to compute hazard ratios (HRs) with 95% confidence intervals (CIs) for each outcome, pairwise comparing treatment with dalteparin or dabigatran with rivaroxaban as the reference. The HRs were both computed using a multivariable and a propensity score matched analysis.Aims
Methods
To assess the safety of tranexamic acid (TXA) in a large cohort of patients aged over 65 years who have sustained a hip fracture, with a focus on transfusion rates, mortality, and thromboembolic events. This is a consecutive cohort study with prospectively collected registry data. Patients with a hip fracture in the Region of Southern Denmark were included over a two-year time period (2015 to 2017) with the first year constituting a control group. In the second year, perioperative TXA was introduced as an intervention. Outcome was transfusion frequency, 30-day and 90-day mortality, and thromboembolic events. The latter was defined as any diagnosis or death due to arterial or venous thrombosis. The results are presented as relative risk (RR) and hazard ratio (HR) with 95% confidence intervals (CIs).Aims
Methods
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). 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.Aims
Methods
The aim of this study was to give estimates of the incidence of component incompatibility in hip and knee arthroplasty and to test the effect of an online, real-time compatibility check. Intraoperative barcode registration of arthroplasty implants was introduced in Denmark in 2013. We developed a compatibility database and, from May 2017, real-time compatibility checking was implemented and became part of the registration. We defined four classes of component incompatibility: A-I, A-II, B-I, and B-II, depending on an assessment of the level of risk to the patient (A/B), and on whether incompatibility was knowingly accepted (I/II).Aims
Materials and Methods
Aseptic loosening is the leading cause of revision of total hip arthroplasty (THA). It is well recognized that an occult infection is the underlying cause of some aseptic revisions. Intraoperative cultures are central to the diagnosis of prosthetic joint infection (PJI). However, the diagnostic and prognostic value of unexpected positive intraoperative cultures remains unclear. The aim was to study whether first-time aseptic revision of a total hip arthroplasty with unexpected bacterial growth in cultures of intraoperatively taken biopsies have an increased risk of secondary revision due to all causes and increased risk of PJI revision, specifically. Cases reported as first-time aseptic loosening revisions to the Danish Hip Arthroplasty Register (DHR) performed during January 1st, 2010, to May 15th, 2016, were included. DHR data were merged with the Danish Microbiology Database, which contains data from all intraoperatively obtained cultures in Denmark. Included first-time revisions were grouped based on the number of positive cultures growing the same bacteria genus: ≥2, 1 and 0 cultures. Revisions were followed until secondary revision, death, or end of follow-up period after one year. Relative risk for secondary revision due to all causes and PJI was estimated.Aim
Method
What is the fate of revision total joint arthroplasty, when conventional tissue sample culture (TSC) is negative and sonication fluid culture (SFC) is positive, in terms of re-revision? We prospectively analyzed explanted prosthetic materials from 211 consecutive cases of total hip and knee arthroplasty revision surgery performed on any indication during a one year period. We used a sonication apparatus and protocol that was previously described [Borens et al, 2013. J Orthop Res]. Sampling of five periprosthetic tissue biopsies was performed according to the local protocol and incubated for 5 days. In our non-interventional study design, clinicians were blinded to the results from sonication-culture, which were not used for the subsequent treatment strategy. In cases with suspected deep infection, thorough debridement was performed during revision surgery, and routine antibiotic treatment was dicloxacillin for 6–8 weeks. Patients were routinely seen in the outpatient clinic after 3 and 12 months, where clinical examination and any antibiotic treatment were documented. Minimum follow-up was 1 year. This cohort study is reported according to the STROBE guidelines.Aim
Method
To study whether revision for prosthetic joint infection (PJI) after early PJI in primary Total Hip Arthroplasty (THA) is associated with a high mortality, when compared with: Patients, who did not undergo revision for any reason and Patients who underwent an aseptic revision. This population-based cohort study was based on the Danish Hip Arthroplasty Register on primary THA performed in Denmark from 2005 to 2014. Data from the Danish Hip Arthroplasty Register were linked to microbiology databases, the National Register of Patients, and the Civil Registration System to obtain data on microbiology, comorbidity, and vital status on all patients. The mortality risk for the patients who underwent revision for PJI within 1 year from implantation of primary THA was compared with (1) the mortality risk for patients who did not undergo revision for any reason within 1 year of primary THA; and (2) the mortality risk for patients who underwent an aseptic revision.Aim
Method
The primary aim of this in vitro study was to test the efficacy of daptomycin to eradicate staphylococcal biofilms on various orthopedic implant surfaces and materials. The secondary aim was to quantitatively estimate the formation of staphylococcal biofilm on various implant materials with different surface properties. We tested six clinically important biomaterials: cobalt chrome alloy, pure titanium, grid-blasted titanium, porous plasma-coated titanium with/without hydroxyapatite, and polyethylene. Two laboratory strains of bacteria commonly causing PJI were used, namely The time to detection expressed as the heat flow >50 µW (TTD-50) indirectly quantifies the initial amount of biofilm bacteria, with a shorter TTD-50 representing a larger amount of bacteria.Aim
Method
The metal on metal implants was introduced without the proper stepwise introduction. The ASR resurfacing hip arthroplasty (RHA) withdrawn due to high clinical failure rates and the large diameter head THA (LDH-THA) are also widely abandoned. Early (2 year) radiostereometry studies does not support early instability as cause of failure but more likely metal wear products. A possible advantage may be maintenance of bone mineral density (BMD). We present 5 year prospective follow up from a randomized series, aiming to report changes from baseline and to investigate links between implant micromotion, Cr & Co ions and BMD. Patients eligible for an artificial hip were randomized to RHA, Biomet LDH-THA or standard Biometric THA. 19, 17 and 15 patients completed 5 year follow-up. All followed with BMD of the femur, acetabulum and for RHA the collum. RHA and THA with whole blood Co and Co. LDH-THA only at 5 year. RHA had marker based RSA of both components, cup only for LDH-THA. Translations were compiled to total translation (TT= √(x2+y2+z2)). Data were collected at baseline, 8 weeks, 6 months, 1, 2 and 5 years. Statistical tests: ANCOVA for TT movement, Spearman's correlation for BMD, Cr, Co and BMI to TT at 5 years RSA: The 5 year median (25%to75%) RHA cup translations were X=-0.00(−0.49 to 0.19) Y=0.15(−0.03 to 0.20), z=0.24(−0.42 to 0.37) and TT 0.58 (0.16 to 1.82) mm. For the LDH-THA X=−0.33(−0.90 to 0.20) Y=0.28(0.02 to 0.54), z=0.43(−1.12 to −0.19) and TT 1.06 (0.97 to 1.72) mm. The TT was statistically different (p<0.05) for the two cups. The RHA femoral component moved X=0.37(0.21 to 0.56) Y=0.02(−0.07 to 0.11), z=-0.01(−0.07 to 0.26) and TT 0.48 (0.29 to 0.60) mm at 5 years. There was no TT movement from year 2. The mean (SD) acetabular BMD was diminished to 93(90–97)% for RHA and 97(93–99.9)% for THA, but LDH-THA maintained 99(95–103)%. Overall femoral BMD was unchanged at 5 years for all interventions, but both stemmed implants lost 17% at the calcar. Median (25%to75%) whole-blood Cr peaked in the LDH-THA group with 1.7 (0.9 to 3.1) followed by RHA 1.2 (0.8 to 5.0) and THA with 0.5 (0.4 to 0.7)ppb. For Co the highest levels were found in RHA with 1.6(0.8 to 4.7) followed by LDH-THA 1.2 (0.7–1.7) and THA 0.2 (0.2 to 0.6) ppb. The only correlations above +/−0.3 for TT were the RHA femoral component with a correlation of 0.47 to BMI, 0.30 to Co and Cr. The ASR cup conversely had a negative correlation of −0.60 to BMI and again, the LDH-THA cup had a negative correlation of −0.37 to Cr. In contrast to registered revision rates, we found significantly larger movement for the Biomet cup than the ASR cup. The metal ion levels were similar. The LDH-THA cup maintained the acetabular BMD best at 5 years, but the difference was small, we are limited by small numbers and the correlations between TT and the covariates showed no clear pattern.
The purpose of this study was to validate the diagnosis of periprosthetic
joint infection (PJI) in the Danish Hip Arthroplasty Register (DHR). We identified a cohort of patients from the DHR who had undergone
primary total hip arthroplasty (THA) since 1 January 2005 and followed
them until first-time revision, death, emigration or until 31 December
2012. Revision for PJI, as registered in the DHR, was validated against
a benchmark which included information from microbiology databases,
prescription registers, clinical biochemistry registers and clinical
records. We estimated the sensitivity, specificity, positive predictive
value (PPV) and negative predictive value (NPV) for PJI in the DHR
alone and in the DHR when combined with microbiology databases.Aims
Patients and Methods
We conducted a randomized controlled trial (RCT) to investigate if iodine impregnated incision drapes (IIID) increases bacterial recolonization rates compared to no drape use under conditions of simulated total knee arthroplasty (TKA) surgery. Background: To prevent surgical site infection (SSI), one of the important issues is managing the patient´s own skin flora. Many prophylactic initiatives have been suggested, including the use of IIID. IIID has been debated for many years and was deemed ineffective in preventing SSI in a recent systematic review [1], while some evidence suggests a potential increase in postoperative infection risk, as a result of IIID use [2]. IIID is sparsely investigated in orthopaedic surgery. An increase in the number of viable bacteria in the surgical field of an arthroplasty operation has a potential to increase the risk of SSI in an otherwise elective and clean procedure [3]. 20 patients scheduled for TKA were recruited. Each patient had one knee randomized for draping with IIID [4] while the contralateral knee was left bare, thus the patients acted as their own controls. Operating theater settings with laminar airflow and standard perioperative procedures were simulated. Sampling was performed with the cup-scrup technique [5] using appropriate neutralizers. Samples were collected from the skin of each knee prior to disinfection and on 2 occasions after skin-preparation, 75 minutes apart. Bacterial quantities were estimated by spread plating with 48-hour aerobic incubation. Outcome was measured as colony forming units per square centimeter of skin. We used Wilcoxon signed-rank test for comparative analysis within and between knees. Following skin-disinfection we found no significant difference in bacterial quantities between the intervention and the control knee (p = 0.388). Neither did we see any difference in bacterial quantities between the two groups after 75 minutes of simulated surgery (p = 0.367). When analyzed within the intervention and control group, bacterial quantities had not significantly increased at the end of surgery when compared to baseline, thus no recolonization was detected (p = 0.665 and 0.609, respectively). Iodine impregnated incision drapes did not increase bacterial recolonization rates in simulated TKA surgery. Thus, the results of this RCT study does not support the hypothesis that iodine impregnated incision drapes promotes bacterial recolonization and postoperative infection risk.
To compare the number of airborne bacteria and particles under laminar airflow (LAF) versus turbulent airflow (TAF) with 100% and 50% reduced fresh air exchange during simulated total hip arthroplasty (THA) Two equally dimensioned operating rooms (OR) build in 2009 with modern ventilation systems of LAF and TAF respectively were used during 32 simulated THA-operations under four different ventilation conditions: LAF or TAF with either full (n=8+8) or 50% reduced (n=8+8) fresh air exchange volume. We followed a protocol controlling the complete perioperative setup including interior cleaning, sterile materials, OR-personnel procedures, surgical clothing, instruments and 50-minute surgical procedure on a full-sized dummy at 37°C. Microbial contamination was determined intra-operatively by ISO-validated Microbiological Active Sampler (MAS-100, Merck, 100 L/min) at two 10-minute intervals in 30 cm distance of the operating field. Blood-agar plates from each operation were incubated for 2 days at 35°C and the microbial concentration was determined by viable counting of colony-forming units (CFU) per m3 air. Furthermore airborne particulate (0,5–10 µm) was sampled with ISO-validated light scattering particle analyzer (MET-one, Beckman Coulter, 28,3 L/min) during the 50-minute surgical procedure (1,42 m3/operation). Large particle sizes (>5 µm) are correlated with microbial contamination (Stocks, 2010). According to standards large-sized particle number must not exceed a 2.900/m3-threshold for cleanroom operations. Microbial air concentration (mean CFU/m3 ±standard deviation) under LAF conditions with full and 50% reduced fresh air exchange were 0,4±0,8 and 0,4±0,4 respectively, whereas air contamination under TAF conditions were significantly higher with 7,6±2,0 and 10,3±8,1 (p<0,05). Large (>5 µm) airborne particulate (mean no./m3 ±standard deviation) under LAF conditions with full and 50% reduced fresh air exchange were 1.581±2.841 and 1.018±1.084 respectively, whereas particulate under TAF conditions were 7.923±5.151 and 6.157±2.439 respectively. Microbial air contamination was significantly lower under LAF ventilation compared to TAF during simulated THA under both full and 50% reduced fresh air exchange in modern operating theatres used in daily clinic. The number of particles measured under TAF conditions exceeded the threshold for cleanroom operations in 12/16 simulated operations. These findings indicate that LAF reduces the airborne microbial risk factor of surgical site infection in comparison to TAF.
The Danish Hip Arthroplasty Register (DHR) is a national database on total hip arthroplasties (THAs) with a high completeness and validity of registration for primary procedures. The aim was to validate the registration in DHR for revisions due to Prosthetic Joint Infection (PJI). We identified a cohort of patients in the DHR who underwent primary THA from January 1, 2005 to December 31, 2012 and we followed these patients until first-time revision, death, emigration or December 31, 2012. The PJI diagnosis registered was tested against a gold standard encompassing information from microbiology, prescription, and clinical biochemistry registries in combination with clinical findings retrieved from medical records. We estimated the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) with 95% confidence interval (CI) for PJI in DHR alone and in DHR combined with microbiology registries. Out of 37,828 primary THAs, 1,382 were registered with any revision, 232 of which were due to PJI. For PJI revisions in DHR, the sensitivity was 67.0% (CI: 61.0 – 72.6), specificity 95.2% (CI: 93.8 – 96.4), PPV 77.2% (CI: 71.2 – 82.4), and NPV 92.3% (CI 90.7 – 93.8). Combining DHR with microbiology registries led to a notable increased in the sensitivity for PJI revision to 90.3% (CI: 86.1 – 93.5) and likewise for specificity 99.6% (CI: 99.1 – 99.9), PPV 98.4% (CI: 95.9 – 99.6) and NPV 98.5% (CI: 97.6 – 99.1). Only two thirds of PJI revisions were captured in DHR and the PPV was moderate. However, combining DHR with microbiology registries improved the accuracy remarkably. The study was supported by Region of Southern Denmark and Lillebaelt Hospitals.
Despite high revision rates, the mean two year migration of the ASRTM cup is within an acceptable threshold. Slightly higher migration rates found for the M2a- Magnum™ Porous Coated Acetabular Component but longer follow up is needed to establish if this implant is at risk. RSA can detect the migration of an implant, and continuous migration is a predictor for failure (1). The ASRTM resurfacing implant was withdrawn from the marked due to excessive failure rate but showed initial femoral component stability. The aim of this study was to investigate the initial implant stability for the ASR cup as a possible explanation for the high revision rate, and to compare it to another metal on metal (MoM) cup.Summary
Introduction
We examined the risk of thrombotic and major
bleeding events in patients undergoing total hip and knee replacement
(THR and TKR) treated with thromboprophylaxis, using nationwide
population-based databases. We identified 83 756 primary procedures
performed between 1997 and 2011. The outcomes were symptomatic venous thromboembolism
(VTE), myocardial infarction (MI), stroke, death and major bleeding
requiring hospitalisation within 90 days of surgery. A total of 1114 (1.3%) and 483 (0.6%) patients experienced VTE
and bleeding, respectively. The annual risk of VTE varied between
0.9% and 1.6%, and of bleeding between 0.4% and 0.8%. The risk of
VTE and bleeding was unchanged over a 15-year period. A total of
0.7% of patients died within 90 days, with a decrease from 1% in
1997 to 0.6% in 2011 (p <
0.001). A high level of comorbidity
and general anaesthesia were strong risk factors for both VTE and
bleeding, with no difference between THR and TKR patients. The risk
of both MI and stroke was 0.5%, which remained unchanged during
the study period. In this cohort study of patients undergoing THR and TKR patients
in routine clinical practice, approximately 3% experienced VTE,
MI, stroke or bleeding. These risks did not decline during the 15-year
study period, but the risk of dying fell substantially. Cite this article:
Radiostereometric analysis (RSA) can detect early
micromovement in unstable implant designs which are likely subsequently
to have a high failure rate. In 2010, the Articular Surface Replacement
(ASR) was withdrawn because of a high failure rate. In 19 ASR femoral
components, the mean micromovement over the first two years after implantation
was 0.107 mm ( We conclude that the ASR femoral component achieves initial stability
and that early migration is not the mode of failure for this resurfacing
arthroplasty.
Total leg muscle function in hip OA patients is not well studied. We used a test-retest protocol to evaluate the reproducibility of single- and multi-joint peak muscle torque and rapid torque development in a group of 40–65 yr old hip patients. Both peak torque and torque development are outcome measures associated with functional performance during activities of daily living. Patients: Twenty patients (age 55.5±3.3, BMI 27.6±4.8) who underwent total hip arthroplasty participated in this study. Reliability: We used the intra-class correlation (ICC) and within subject coefficients of variation (CVws) to evaluate reliability. Agreement: Relative Bland-Altman 95% limits of agreements (LOA) and smallest detectable difference (SDD) were calculated and used for evaluation of measurement accuracy. Parameters: Maximal muscle strength (peak torque, Nm) and rate of torque development (Nm•sec-1) for affected (AF) and non-affected (NA) side were measured during unilateral knee extension-flexion (seated), hip extension-flexion, and hip adduction-abduction (standing), respectively. Contractile RTD100, 200, peak was derived as the average slope of the torque-time curve (torque/time) at 0–100, 0–200 and 0 peak relative to onset of contraction. Protocol: After 5 min level walking at self-selected and maximum speeds each muscle group was tested using 1–2 sub-maximal contraction efforts followed by 3 maximal contractions 4s duration. Statistics: The variance components were estimated using STATA12, with muscle function and occasion as independent variable and patients as random factor, using the restricted maximum likelihood method (=0.05).Introduction
Material and Methods
Metal on metal articulations produce chromium (Cr) and cobalt (Co) debris, particularly when the articulations are worn in. High levels in the peripheral blood are indicative of excess wear and may cause adverse effects. The present RCT investigates metal ion levels and the relationship of Co, Cr ions and lymphocyte counts during the running-in period. Following randomization to RHA (ASRTM, DePuy) or THA we obtained whole blood (wb), and serum (s) samples at baseline, 8 w, 6 m and 1 y. We measured the Co and Cr concentrations, the total lymphocyte count as well as the CD3+, CD4+, CD8+, CD19+ and CD16+/CD56+ sub populations. Cup inclination and anteversion angles came from conventional radiographs. Activity was measured as steps by pedometer and UCLA activity. Data are presented as median (range).Introduction
Materials and Methods
The treatment of femoral neck fracture with internal fixation (IF) is recommended in younger patients and has compared to arthroplasty the advantage of retaining the femoral head. A big problem with osteosynthesis is though failure. Finding predictors for fixation failure is still an ongoing process and osteoporosis has been suggested as a predictor. To correlate bone mineral density (BMD) in regard to failure of IF in osteosynthesized femoral neck fractures.Background
Aim
Osteoporosis (OP), osteoarthrosis (OA), and rheumatoid arthritis (RA) are the most common age-related degenerative bone diseases, and major public health problems in terms of enormous amount of economic cost. RA is considered as a major cause of secondary osteoporosis. At late stage, OP often leads to skeletal fractures, and OA and RA result in severe joint disability. Over the last a few decades, much significant research on the properties has been carried out on these diseases, however, a detailed comparison of the microarchitecture of cancellous bones of these diseases is not available. In this study, we investigated three-dimensional (3-D) microarchitectural properties of OP, OA and RA cancellous bone. We hypothesized that there were significant differences in microarchitecture among OP, OA and RA bone tissues that might lead to different bone quality. Twenty OP, fifty OA, and twelve RA femur heads were harvested from patients undergone total hip replacement surgery. Cubic cancellous bone samples (8∗8∗8 mm3) were prepared and scanned with a high resolution microtomographic system (vivaCT 40, Scanco Medical AG., Brüttisellen, Switzerland). Then micro-CT images were segmented using individual thresholds to obtain accurate 3-D data sets. Detailed microarchitectural properties were evaluated based on novel unbiased, model-free 3-D methods. For statistical analysis, one-way ANOVA was used, and a p<0.05 was considered significant.Introduction
Materials and Method
The combined incubation of a composite scaffold with bone marrow stromal cells in a perfusion bioreactor could make up a novel hybrid graft material with optimal properties for early fixation of implant to bone. The aim of this study was to create a bioreactor activated graft (BAG) material, which could induce early implant fixation similar to that of allograft. Two porous scaffold materials incubated with cells in a perfusion bioreactor were tested in this study. Two groups of 8 skeletally mature female sheep were anaesthetized before aspiration of bone marrow from the iliac crest. For both groups, mononuclear cells were isolated, and injected into a perfusion bioreactor (Millenium Biologix AG, Switzerland). Scaffold granules Ø∼900–1500 μm, ∼88% porosity) in group 1, consisted of hydroxyapatite (HA, 70%) with -tricalcium-phosphate (−TCP, 30%) (Danish Technological Institute, Denmark). The granules were coated with poly-lactic acid (PLA) 12%, in order to increase the mechanical strength of the material (Phusis, France). Scaffold granules Ø∼900–1400 μm, 80% porosity) in group 2 consisted of pure HA/-TCP (Fin Ceramica, Italy). For both groups, cells were incubated in the bioreactor for 2 weeks. Fresh culture medium supplemented with dexamethasone and ascorbic-acid was added every third or fourth day. Porous titanium alloy implants with diameter=length=10mm (Biomet, USA) were inserted bilaterally in each of the distal femurs of the sheep; thus 4 implants in each sheep. The concentric gap (2 mm) surrounding the implant was filled with 1) BAG (autogenous), 2) granules, 3) granules+bone marrow aspirate (BMA, autologous) or 4) allograft. The sheep were euthanized after 6 weeks. Distal femurs were removed and implant-bone samples were divided in two parts. The superficial part was used for mechanical testing and micro-CT scanning, and the profound part for histomorphometry. Push-out tests were performed on an 858 Bionix MTS hydraulic materials testing machine. Shear mechanical properties between implant and newly generated bone were calculated to assess implant fixation. Results were assessed by One-way ANOVA. P-values less than 0.05 were considered significant.Introduction
Methods and Materials
The Oxford hip score (OHS) is a 12-item questionnaire designed
and developed to assess function and pain from the perspective of
patients who are undergoing total hip replacement (THR). The OHS
has been shown to be consistent, reliable, valid and sensitive to
clinical change following THR. It has been translated into different
languages, but no adequately translated, adapted and validated Danish
language version exists. The OHS was translated and cross-culturally adapted into Danish
from the original English version, using methods based on best-practice
guidelines. The translation was tested for psychometric quality
in patients drawn from a cohort from the Danish Hip Arthroplasty
Register (DHR).Objectives
Methods
It is accepted that resurfacing hip replacement
preserves the bone mineral density (BMD) of the femur better than total
hip replacement (THR). However, no studies have investigated any
possible difference on the acetabular side. Between April 2007 and March 2009, 39 patients were randomised
into two groups to receive either a resurfacing or a THR and were
followed for two years. One patient’s resurfacing subsequently failed,
leaving 19 patients in each group. Resurfaced replacements maintained proximal femoral BMD and,
compared with THR, had an increased bone mineral density in Gruen
zones 2, 3, 6, and particularly zone 7, with a gain of 7.5% (95%
confidence interval (CI) 2.6 to 12.5) compared with a loss of 14.6%
(95% CI 7.6 to 21.6). Resurfacing replacements maintained the BMD
of the medial femoral neck and increased that in the lateral zones
between 12.8% (95% CI 4.3 to 21.4) and 25.9% (95% CI 7.1 to 44.6). On the acetabular side, BMD was similar in every zone at each
point in time. The mean BMD of all acetabular regions in the resurfaced
group was reduced to 96.2% (95% CI 93.7 to 98.6) and for the total
hip replacement group to 97.6% (95% CI 93.7 to 101.5) (p = 0.4863).
A mean total loss of 3.7% (95% CI 1.0 to 6.5) and 4.9% (95% CI 0.8
to 9.0) of BMD was found above the acetabular component in W1 and
10.2% (95% CI 0.9 to 19.4) and 9.1% (95% CI 3.8 to 14.4) medial
to the implant in W2 for resurfaced replacements and THRs respectively.
Resurfacing resulted in a mean loss of BMD of 6.7% (95% CI 0.7 to
12.7) in W3 but the BMD inferior to the acetabular component was
maintained in both groups. These results suggest that the ability of a resurfacing hip replacement
to preserve BMD only applies to the femoral side.
For bone grafting procedures, the use of autologous bone is considered the gold standard, as it is has a better healing capacity compared to other alternatives as allograft and synthetic bone substitutes. However, as there are several drawbacks related to autografting (infection, nerve- or vascular damage, chronic pain problems, abdominal herniation), there has been a targeted effort to improve the healing capacities of synthetic bone substitutes. To evaluate the performance of a carbonated osteoionductive hydroxyapatite (CHA) scaffold of clinical relevant size (Ø=15mm, H=50mm) in a sheep model of multi level posterolateral intertransverse lumbar spine fusion after activation with autologous bone marrow nuclear cells (BMNC) in a flow perfusion bioreactor.Background
Aim
We evaluated the short-term of 0 to 90 days and the longer term, up to 12.7 years, mortality for patients undergoing primary total hip replacement (THR) in Denmark in comparison to the general population. Through the Danish Hip Arthroplasty Registry we identified all primary THRs undertaken for osteoarthritis between 1 January 1995 and 31 December 2006. Each patient (n = 44 558) was matched at the time of surgery with three people from the general population (n = 133 674). We estimated mortality rates and mortality rate ratios with 95% confidence intervals for THR patients compared with the general population. There was a one-month period of increased mortality immediately after surgery among THR patients, but overall short-term mortality (0 to 90 days) was significantly lower (mortality rate ratio 0.8; 95% confidence interval 0.7 to 0.9). However, THR surgery was associated with increased short-term mortality in subjects under 60 years old, and among THR patients without comorbidity. Long-term mortality was lower among THR patients than in controls (mortality rate ratio 0.7; 95% confidence interval 0.7 to 0.7). Overall, THR was associated with lower short- and long-term mortality among patients with osteoarthritis. Younger patients and patients without comorbidity before surgery may also experience increased mortality after THR surgery, although the absolute risk of death is small.
9,596 of the 280,201 primary THRs, had been revised. Ten-years survival was 91.9% (95% CI: 91.5 – 92.3) in Denmark, 93.9% (95% CI: 93.6–94.1) in Sweden, and 92.6% (95% CI: 92.3–93.0) in Norway. In Sweden and Norway 23% of revisions were due to dislocation, compared to 34% in Denmark. Replacement of only cup or liner constituted 29% of the revisions in Sweden, 33% in Norway, and 44% in Denmark.
There were no significant differences between the two approaches with regard to pre- and post-operative HHS, WOMAC, patient satisfaction, level of activity and EQ5D
At follow-up weight-bearing AP pelvis radiographs were obtained. OA was present when the minimum joint space width was <
2.0 mm. Radiographs of sex- and age-matched controls were obtained from The Copenhagen City Heart Study. The following criteria for exclusion were applied:
insufficient or missing radiographs patients who refused to participate, emigrated persons, persons lost to follow-up, patients with previous surgery to pelvis or lower limbs and dead persons. 52 patients (55 hips) were enrolled in the study and 115 patients (136 hips) were excluded. Mean age for men at follow-up was 53 years and for women 55 years.
This study also raised some methodological questions that this study tries to answer. What is happening in the dead space around the catheter in the drill canal? And is there an equilibrium period after the insertion of the catheter.
Ex vivo study: in 5 syringes with 5 ml human blood a microdialysis catheter was inserted and microdialysis performed over 3 hours. In vivo study: in the proximal part of the femur in 6 mature Göttingen mini pigs a drill hole was made and microdialysis was performed over 3 hours. The pigs were kept normoventilated during the experiment.
Ex vivo: the microdialysis results showed that lactate kept a steady level and glucose and glycerol all fell, pyruvate fell but leveled out. The lactate/pyruvate ratio increased from 13(4) to 32(6) (p<
0.001). In vivo: relative recovery was 57(11)%. Lactate increased, pyruvate stayed constant, glucose and glycerol fell. The lactate/pyruvate ratio increased from initial 30(8) to 37(8) after 1 hour (p=0.007) but no significant change from 1 to 2 hours was observed.
The in vivo study indicates that an equilibrium period is necessary or that a reference measurement in healthy bone must be used when performing short measurements in bone.
We compared patients’ characteristics and outcome following THA in private and public hos-pitals.
To detect eventual difference in patient characteristics- age, gender, diagnosis leading to THA, Carlson’s comorbidity score and Charnley category were evaluated. We matched 3 658 cases operated in private with 3 658 controllers operated in public hospitals on propensity score. Scoring parameters were age, gender, diagnosis leading to THA, Carlson’s comorbidity score, Charnley category, operating time, type of anesthesia and type of prosthesis. We used multivariate logistic regression on propensity score matched data to assess association between type of hospital and outcome by computing relative risks and 95% Confidence Interval (CI). Outcomes were perioperative complications, readmission within 3 months, re-operation within 2 years, implant failure after 5 years, and mortality within 3 months of surgery.
Patients in private and propensity matched controls from public hospitals showed no differences in age, gender, diagnosis leading to THA, Carlson’s comorbidity score, Charnley category, operating time, type of anesthesia and type of prosthesis (p-value <
0,0001). Based on matched data, private hospitals had lower relative risk for perioperative complications (0.39, 0.26–0.60), reoperations (0.59, 0.41–0.83) and readmissions (0.57, 0.42–0.77) compared with public. There was no difference in mortality or implant failure.
We found significant difference between patient characteristics operated at public versus private hospitals. No difference was evident regarding mortality and implant failure but for complications, reoperations and readmissions between private and public hospitals.
Radiographs of sex- and age-matched controls for the follow-up group were obtained from The Copenhagen City Heart Study. The following criteria for exclusion were applied
emigrated persons, persons lost to follow-up and patients with previous surgery to pelvis or lower limbs. 135 patients (156 hips) were enrolled in this study and 32 patients (35 hips) were excluded.
Surgery and postoperative regime were identical in the two groups. CR-migration during cementation and stem insertion was calculated and the quality of cementation was evaluated on the post-operative X-ray according to the criteria by Barrack et Al( Mean values are presented with 95% CI. An unpaired T-test was used to analyse the differences in CR migration and the quality of cementation quality.
Regarding quality of cementation the mean value in the Imset group were 2.8 which was significantly better in the Hardinge group=2.1 (P=0.003)
Resurfacing THA is claimed to transfer stress naturally to the femur neck and preserve proximal femoral bone mass postoperatively. DXA is an established method in estimating BMD around a standard THA, but due to the anteversion of the femur neck, rotation could affect the size of the neck-regions and thereby the BMD measurements around a RTHA. To our knowledge, this is the first study to analyze the effects of hip rotation on BMD in the femoral neck around a RTHA. We scanned the femoral neck of 15 patients twice in each position of 15° inward, 0° and 15° outward rotation, and analyzed BMD in a single and a six-region model. CVs were calculated for BMD in the same position as well as between different positions. For double measurements in the same position we found mean CVs of 3.1% (range 2.5% – 3.7%) and 4.6% (range 2.2% – 8.6%) in the one- and six-region models, respectively. When the 15° outward position was excluded, the CVs decreased to 2.8% and 4.0%. With rotation, the mean CVs rose to 5.4% (range 3.2%–7.2%) and 11.8% (range 2.7% – 36.3%). This effect was most pronounced in the 6-region model, predominantly in the lateral and distal parts of the femoral neck, where the change was significantly different from the fixated position. For the single-region model 15° rotation could be allowed without compromising the precision. We conclude that rotation adversely affects the precision of BMD measurements around a RTHA, but in the single-region model smaller rotations can be allowed. With the hip fixated the six-region model produces low CVs, acceptable for longitudinal studies. For maximal topographical detail we prefer the six-region model and recommend that future longitudinal DXA studies, including RTHA, be performed standardised, Preferably, with the hip in the neutral or internal rotation.
There is a great need for suitable large animal models that closely resemble osteoporosis in humans, and that they have adequate bone size for bone prosthesis and biomaterial research. This study aimed to investigate effects of a 7 month glucocorticoid (GC) treatment alone without ovariectomy on the properties of sheep cancellous bone. Eighteen female sheep were randomly allocated into 3 groups: group 1 (GC-1) received GC (0.60mg/kg/day methylprednisolone) 5 days weekly for 7 months; group 2 (GC-2) received the same treatment regime for 7 months, and further observed for 3 months without GC; and group 3 served as the control group, and left untreated for 7 months. The sheep received restricted diet. After 7 months of GC treatment. Cancellous bone volume fraction of the 5th lumbar vertebra in the GC-1 group was reduced by −35%, trabecular thickness by −28%, and changed from typical plate structure to a combination of plate and rod structure with increased connectivity by 202%. Bone strength was reduced by 52%. Bone formation marker, serum osteocalcin of GC-1, was reduced by 71% at 7 months, but recovered with an increase of 45% at 10 month in the GC-2 group. Similar trends were also seen in the femur and tibia. At 10 months, the GC-2 group had microarchitectural and mechanical properties similar to the level of the control sheep. We have demonstrated in this study that 7 month high-dose GC on bone density and microarchitecture are comparable with those observed in human after long-term GC treatment. Moreover, we have shown that the bone quality with regard to strength and microarchitecture recovers after 3 months further observation without GC. This suggests that a prolonged administration of GC is needed for long-term observation to keep osteopenic bone. The model will be useful in pre-clinical studies.
The procedures were reviewed with primary focus on perioperative blood loss, length of surgery and neurovascular complications. Patients who underwent combined surgery of acetabulum and femur were excluded. Data are presented as mean with 95% confidence interval (CI) in brackets.
The MI group had 1 case of major arterial bleeding, however no blood transfusion. The II group had 2 cases of arterial thrombosis and one transient sciatic nerve palsy. One patient received blood transfusion.
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.
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.
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.
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 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.
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.
We recorded inter- and intra-observer variations in the classification of ankle fractures by the Lauge Hansen and Weber systems. Radiographs of 94 patients were classified independently by four observers. The observer variation was calculated by kappa statistics, which corrects the obtained values for the agreement expected by chance. There was an acceptable level of agreement for the overall classification into both systems. For the staging of supination-adduction and supination-eversion fractures in the Lauge Hansen system the agreement was poor. The results indicate that future classification systems should be subject to reliability analysis before they are accepted.