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1.  Increased risk of revision for infection in rheumatoid arthritis patients with total hip replacements 
Acta Orthopaedica  2015;86(4):469-476.
Background and purpose
Medical treatment of rheumatoid arthritis (RA) has changed dramatically over the last 15 years, including immune modulation. We investigated the risk of revision for infection after primary total hip replacement (THR) in patients with rheumatoid arthritis over a 16-year period, and compared it with that in THR patients with osteoarthritis (OA).
Patients and methods
We identified 13,384 THRs in RA patients and 377,287 THRs in OA patients from 1995 through 2010 in a dataset from the Nordic Arthroplasty Register Association (NARA). Kaplan-Meier survival curves, with revision for infection as the endpoint, were constructed. Cox regression analyses were performed to calculate the relative risk (RR) of revision for infection adjusted for age, sex, fixation technique, and year of primary surgery.
RA patients had a 1.3 times (95% CI 1.0–1.6) higher risk of revision for infection. After 2001, this risk increased more for RA patients than for OA patients. During the first 3 months and from 8 years postoperatively, the risk of revision for infection was higher in RA patients with THRs fixated with antibiotic-loaded cement than in corresponding OA patients.
We found a slightly higher overall risk of revision for infection in RA patients than in OA patients, but this difference was only present after 2001. In THRs with antibiotic-loaded cement, the risk of very early and late infections leading to revision was higher in RA patients than in OA patients.
PMCID: PMC4513603  PMID: 25782042
2.  Comparison of the risk of revision in cementless total hip arthroplasty with ceramic-on-ceramic and metal-on-polyethylene bearings 
Acta Orthopaedica  2015;86(4):477-484.
Background and purpose
Ceramic-on-ceramic (CoC) bearings were introduced in total hip arthroplasty (THA) to reduce problems related to polyethylene wear. We compared the 9-year revision risk for cementless CoC THA and for cementless metal-on-polyethylene (MoP) THA.
Patients and methods
In this prospective, population-based study from the Danish Hip Arthroplasty Registry, we identified all the primary cementless THAs that had been performed from 2002 through 2009 (n = 25,656). Of these, 1,773 THAs with CoC bearings and 9,323 THAs with MoP bearings were included in the study. To estimate the relative risk (RR) of revision, we used regression with the pseudo-value approach and treated death as a competing risk.
444 revisions were identified: 4.0% for CoC THA (71 of 1,773) and 4.0% for MoP THA (373 of 9,323). No statistically significant difference in the risk of revision for any reason was found for CoC and MoP bearings after 9 years of follow-up (adjusted RR = 1.3, 95% CI: 0.72–2.4). Revision rates due to component failure were 0.5% (n = 8) for CoC bearings and 0.1% (n = 6) for MoP bearings (p < 0.001). 6 patients with CoC bearings (0.34%) underwent revision due to ceramic fracture.
When compared to the “standard” MoP bearings, CoC THA had a 33% higher (though not statistically significantly higher) risk of revision for any reason at 9 years.
PMCID: PMC4513604  PMID: 25637339
3.  Increased risk of revision of cementless stemmed total hip arthroplasty with metal-on-metal bearings 
Acta Orthopaedica  2015;86(4):491-497.
Background and purpose
Data from the national joint registries in Australia and England and Wales have revealed inferior medium-term survivorship for metal-on-metal (MoM) total hip arthroplasty (THA) than for metal-on-polyethylene (MoP) THA. Based on data from the Nordic Arthroplasty Register Association (NARA), we compared the revision risk of cementless stemmed THA with MoM and MoP bearings and we also compared MoM THA to each other.
Patients and methods
We identified 32,678 patients who were operated from 2002 through 2010 with cementless stemmed THA with either MoM bearings (11,567 patients, 35%) or MoP bearings (21,111 patients, 65%). The patients were followed until revision, death, emigration, or the end of the study period (December 31, 2011), and median follow-up was 3.6 (interquartile range (IQR): 2.4–4.8) years for MoM bearings and 3.4 (IQR: 2.0–5.8) years for MoP bearings. Multivariable regression in the presence of competing risk of death was used to assess the relative risk (RR) of revision for any reason (with 95% confidence interval (CI)).
The cumulative incidence of revision at 8 years of follow-up was 7.0% (CI: 6.0–8.1) for MoM bearings and 5.1% (CI: 4.7–5.6) for MoP bearings. At 6 years of follow-up, the RR of revision for any reason was 1.5 (CI: 1.3–1.7) for MoM bearings compared to MoP bearings. The RR of revision for any reason was higher for the ASR (adjusted RR = 6.4, CI: 5.0–8.1), the Conserve Plus (adjusted RR = 1.7, CI: 1.1–2.5) and “other” acetabular components (adjusted RR = 2.4, CI: 1.5–3.9) than for MoP THA at 6 years of follow-up.
At medium-term follow-up, the survivorship for cementless stemmed MoM THA was inferior to that for MoP THA, and metal-related problems may cause higher revision rates for MoM bearings with longer follow-up.
PMCID: PMC4513606  PMID: 25715878
4.  The effects of hydroxyapatite coating and bone allograft on fixation of loaded experimental primary and revision implants 
Acta orthopaedica Scandinavica  2003;74(3):239-247.
We used our established experimental model of revision joint replacement to examine the roles of hydroxyapatite coating and bone graft in improving the fixation of revision implants. The revision protocol uses the Søballe micromotion device in a preliminary 8-week period of implant instability for the presence of particulate polyethylene. During this procedure, a sclerotic endosteal bone rim forms, and a dense fibrous membrane is engendered, having macrophages with ingested polyethylene and high levels of inflammatory cytokines. At the time of revision after 8 weeks, the cavity is revised with either a titanium alloy (Ti) or a hydroxyapatite (HA) 6.0 mm plasma-sprayed implant, in the presence or absence of allograft packed into the initial 0.75 mm peri-implant gap. The contralateral limb is subjected to primary surgery with the same implant configuration, and serves as control. 8 implants were included in each of the 8 treatment groups (total 64 implants in 32 dogs). The observation period was 4 weeks after revision. Outcome measures are based on histomorphometry and mechanical pushout properties. The revision setting was always inferior to its primary counterpart. Bone graft improved the revision fixation in all treatment groups, as also did the HA coating. The sole exception was revision-grafted HA implants, which reached the same fixation as primary Ti and HA grafted implants. The revision, which was less active in general, seems to need the dual stimulation of bone graft and HA implant surface, to obtain the same level of fixation associated with primary implants. Our findings suggest that the combination of HA implant and bone graft may be of benefit in the clinical revision implant setting.
PMCID: PMC4495908  PMID: 12899541
5.  The “true” incidence of surgically treated deep prosthetic joint infection after 32,896 primary total hip arthroplasties 
Acta Orthopaedica  2015;86(3):326-334.
Background and purpose
It has been suggested that the risk of prosthetic joint infection (PJI) in patients with total hip arthroplasty (THA) may be underestimated if based only on arthroplasty registry data. We therefore wanted to estimate the “true” incidence of PJI in THA using several data sources.
Patients and methods
We searched the Danish Hip Arthroplasty Register (DHR) for primary THAs performed between 2005 and 2011. Using the DHR and the Danish National Register of Patients (NRP), we identified first revisions for any reason and those that were due to PJI. PJIs were also identified using an algorithm incorporating data from microbiological, prescription, and clinical biochemistry databases and clinical findings from the medical records. We calculated cumulative incidence with 95% confidence interval.
32,896 primary THAs were identified. Of these, 1,546 had first-time revisions reported to the DHR and/or the NRP. For the DHR only, the 1- and 5-year cumulative incidences of PJI were 0.51% (0.44–0.59) and 0.64% (0.51–0.79). For the NRP only, the 1- and 5-year cumulative incidences of PJI were 0.48% (0.41–0.56) and 0.57% (0.45–0.71). The corresponding 1- and 5-year cumulative incidences estimated with the algorithm were 0.86% (0.77–0.97) and 1.03% (0.87–1.22). The incidences of PJI based on the DHR and the NRP were consistently 40% lower than those estimated using the algorithm covering several data sources.
Using several available data sources, the “true” incidence of PJI following primary THA was estimated to be approximately 40% higher than previously reported by national registries alone.
PMCID: PMC4443464  PMID: 25637247
6.  The Verbal Rating Scale Is Reliable for Assessment of Postoperative Pain in Hip Fracture Patients 
Pain Research and Treatment  2015;2015:676212.
Background. Hip fracture patients represent a challenge to pain rating due to the high prevalence of cognitive impairment. Methods. Patients prospectively rated pain on the VRS. Furthermore, patients described the changes in pain after raising their leg, with one of five descriptors. Agreement between paired measures on the VRS at rest and by passive straight leg raise with a one-minute interval between ratings at rest and three-minute interval for straight leg raise was expressed by kappa coefficients. Reliability of this assessment of pain using the VRS was compared to the validity of assessing possible change in pain from the selected descriptors. Cognitive status was quantified by the short Orientation-Memory-Concentration Test. Results. 110 patients were included. Paired scores with maximum disagreement of one scale point reached 97% at rest and 95% at straight leg raise. Linear weighted kappa coefficients ranged from 0.68 (95% CI = 0.59–0.77) at leg raise to 0.75 (95% CI = 0.65–0.85) at rest. Unweighted kappa coefficients of agreement in recalled pain compared to agreement of paired VRS scores ranged from 0.57 (95% CI = 0.49–0.65) to 0.36 (95% CI = 0.31–0.41). Interpretation. The VRS is reliable for assessment of pain after hip fracture. The validity of intermittent questioning about possible change in pain intensity is poor.
PMCID: PMC4452862  PMID: 26078880
7.  Hydroxyapatite coating does not improve uncemented stem survival after total hip arthroplasty! 
Acta Orthopaedica  2015;86(1):18-25.
Background and purpose
It is still being debated whether HA coating of uncemented stems used in total hip arthroplasty (THA) improves implant survival. We therefore investigated different uncemented stem brands, with and without HA coating, regarding early and long-term survival.
Patients and methods
We identified 152,410 THA procedures using uncemented stems that were performed between 1995 and 2011 and registered in the Nordic Arthroplasty Register Association (NARA) database. We excluded 19,446 procedures that used stem brands less than 500 times in each country, procedures performed due to diagnoses other than osteoarthritis or pediatric hip disease, and procedures with missing information on the type of coating. 22 stem brands remained (which were used in 116,069 procedures) for analysis of revision of any component. 79,192 procedures from Denmark, Norway, and Sweden were analyzed for the endpoint stem revision. Unadjusted survival rates were calculated according to Kaplan-Meier, and Cox proportional hazards models were fitted in order to calculate hazard ratios (HRs) for the risk of revision with 95% confidence intervals (CIs).
Unadjusted 10-year survival with the endpoint revision of any component for any reason was 92.1% (CI: 91.8–92.4). Unadjusted 10-year survival with the endpoint stem revision due to aseptic loosening varied between the stem brands investigated and ranged from 96.7% (CI: 94.4–99.0) to 99.9% (CI: 99.6–100). Of the stem brands with the best survival, stems with and without HA coating were found. The presence of HA coating was not associated with statistically significant effects on the adjusted risk of stem revision due to aseptic loosening, with an HR of 0.8 (CI: 0.5–1.3; p = 0.4). The adjusted risk of revision due to infection was similar in the groups of THAs using HA-coated and non-HA-coated stems, with an HR of 0.9 (CI: 0.8–1.1; p = 0.6) for the presence of HA coating. The commonly used Bimetric stem (n = 25,329) was available both with and without HA coating, and the adjusted risk of stem revision due to aseptic loosening was similar for the 2 variants, with an HR of 0.9 (CI: 0.5–1.4; p = 0.5) for the HA-coated Bimetric stem.
Uncemented HA-coated stems had similar results to those of uncemented stems with porous coating or rough sand-blasted stems. The use of HA coating on stems available both with and without this surface treatment had no clinically relevant effect on their outcome, and we thus question whether HA coating adds any value to well-functioning stem designs.
PMCID: PMC4366665  PMID: 25175664
8.  Cirrhosis patients have increased risk of complications after hip or knee arthroplasty 
Acta Orthopaedica  2015;86(1):108-113.
Background and purpose
The risk of complications in cirrhosis patients after orthopedic surgery is unclear. We examined this risk after total hip arthroplasty (THA) or total knee arthroplasty (TKA).
Patients and methods
Using Danish healthcare registries, we identified all Danish residents who underwent a THA or TKA for primary osteoarthritis in the period 1995–2011. We compared the risk of complications in patients with or without cirrhosis.
The surgical technique was similar in the 363 cirrhosis patients and in 109,159 reference patients, but cirrhosis patients were more likely to have been under general anesthesia (34% vs. 23%), were younger (median age 66 vs. 69 years), had a predominance of males (54% vs. 41%), had more comorbidity, and had had more hospitalizations preoperatively. Their risk of intraoperative complications was similar to that for reference patients (2.5% vs. 2.0%), but they had greater risk of dying during hospitalization or within 30 days of discharge (1.4% vs. 0.4%; aOR = 3.9, 95% CI: 1.5–10); greater risk of postoperative transfer to an intensive care unit (0.6% vs. 0.06%; aOR = 5.8, CI: 1.3–25) or a medical department (4.4% vs. 2.5%; aOR = 1.7, CI: 0.99–2.9); greater risk of readmission within 30 days of discharge (15% vs. 8%; aOR = 1.8, CI: 1.3–2.4); and greater risk of deep prosthetic infection (3.1% vs. 1.4%) or revision (3.7% vs. 1.7%) within 1 year. The chance of having an uncomplicated procedure was 81.0% (CI: 76.6–85.0) for cirrhosis patients and 90.0% (CI: 89.6–90.0) for reference patients.
Cirrhosis patients had a higher risk of postoperative complications after THA or TKA for primary osteoarthritis than patients without cirrhosis. This may have implications for orthopedic surgeons’ postoperative management of cirrhosis patients, and preoperative assessment by a hepatologist may be indicated.
PMCID: PMC4366671  PMID: 25238440
9.  The effect of posterior and lateral approach on patient-reported outcome measures and physical function in patients with osteoarthritis, undergoing total hip replacement: a randomised controlled trial protocol 
Total hip replacement provides pain relief and improves physical function and quality of life in patients with end-stage hip osteoarthritis. The incidence of hip replacement operations is expected to increase due to the growing elderly population. Overall, the posterior approach and lateral approach are the two most commonly used approaches for hip replacement operations. The posterior approach is associated with an increased risk of revision due to dislocations, and some studies have shown that the lateral approach is associated with reduced patient-reported outcomes, including physical function and pain; however, this has not been investigated in a randomised controlled trial with a twelve-month follow-up. We hypothesized that the lateral approach has an inferior outcome in patient-reported outcome compared with the posterior approach after one year.
The trial is a prospective, double blinded, parallel-group controlled trial with balanced randomisation [1: 1]. Patients with hip osteoarthritis scheduled for hip replacement surgery, aged 45–70 years, will be consecutively recruited and randomised into two groups. Group A will receive hip replacement using the posterior approach, and Group B will receive hip replacement using the lateral approach. The primary end-point for assessing the outcome of the two interventions will be twelve months after surgery. Follow-up will also be performed after three and six months. The primary outcome is Hip Disability and Osteoarthritis Outcome Score, subscale of "Physical function Short form" (HOOS-PS) Secondary outcome measures include two other subscales of HOOS ("Pain" and "Hip related Quality of Life"), physical activity level (UCLA activity score), limping (HHS) and general health status (EQ-5D-3L). Explorative outcomes include physical function test, 3D-gait-analysis and muscle strength.
To our knowledge, this is the first randomised controlled trial comparing the posterior approach with the lateral approach with patient reported outcome as the primary outcome and with a twelve-month follow-up.
Trial registration NCT01616667.
PMCID: PMC4216831  PMID: 25345483
Osteoarthritis; Hip replacement; Surgical approach
10.  Test-retest reliability of Common Mental Disorders Questionnaire (CMDQ) in patients with total hip replacement (THR) 
BMC Psychology  2014;2(1):32.
The Common Mental Disorders Questionnaire (CMDQ) is used to assess patients’ mental health. It has previously been shown to provide a sensitive and specific instrument for general practitioner setting but has so far not been tested in hospital setting or for changes over time (test-retest). The aim of this study is, by means of a test-retest method, to investigate the reliability of the instrument over time with total hip replacement (THR) patients.
Forty-nine hip osteoarthritis patients who had undergone THR answered the questionnaire twelve months after their operation. Fourteen days later they completed it again. Covering emotional disorder, anxiety, depression, concern, somatoform disorder and alcohol abuse, the questionnaire consists of 38 items with six subscales, each of which has between 4 to 12 items. A five-point Likert scale (from 0–4) is used.
For each of the 38 questions, a quadratic-weighted Kappa coefficient of 0.42 (0.68 – 0.16) to 0.98 (1.00 – 0.70) was found. A Cronbach’s alpha of 0.94 for all the questions indicated high internal consistency.
The results showed a moderate to almost perfect reliability of CMDQ of this specific population.
Trial registration
Current Controlled Trials: NCT01205295
PMCID: PMC4317134  PMID: 25685352
Test-retest; Reliability; Mental disorders; CMDQ; Kappa; Missing
11.  Countrywise results of total hip replacement 
Acta Orthopaedica  2014;85(2):107-116.
Background and purpose
An earlier Nordic Arthroplasty Register Association (NARA) report on 280,201 total hip replacements (THRs) based on data from 1995–2006, from Sweden, Norway, and Denmark, was published in 2009. The present study assessed THR survival according to country, based on the NARA database with the Finnish data included.
Material and methods
438,733 THRs performed during the period 1995–2011 in Sweden, Denmark, Norway, and Finland were included. Kaplan-Meier survival analysis was used to calculate survival probabilities with 95% confidence interval (CI). Cox multiple regression, with adjustment for age, sex, and diagnosis, was used to analyze implant survival with revision for any reason as endpoint.
The 15-year survival, with any revision as an endpoint, for all THRs was 86% (CI: 85.7–86.9) in Denmark, 88% (CI: 87.6–88.3) in Sweden, 87% (CI: 86.4–87.4) in Norway, and 84% (CI: 82.9–84.1) in Finland. Revision risk for all THRs was less in Sweden than in the 3 other countries during the first 5 years. However, revision risk for uncemented THR was less in Denmark than in Sweden during the sixth (HR = 0.53, CI: 0.34–0.82), seventh (HR = 0.60, CI: 0.37–0.97), and ninth (HR = 0.59, CI: 0.36–0.98) year of follow-up.
The differences in THR survival rates were considerable, with inferior results in Finland. Brand-level comparison of THRs in Nordic countries will be required.
PMCID: PMC3967250  PMID: 24650019
12.  Local anesthetic wound infiltration for pain management after periacetabular osteotomy 
Acta Orthopaedica  2014;85(2):141-146.
Background and purpose
To our knowledge, there is no evidence to support the use of local infiltration analgesia (LIA) for postoperative pain relief after periacetabular osteotomy (PAO). We investigated the effect of wound infiltration with a long-acting local anesthetic (ropivacaine) for postoperative analgesia after PAO.
Patients and methods
We performed a randomized, double-blind, placebo-controlled trial ( NCT00815503) in 53 patients undergoing PAO to evaluate the effect of local anesthetic infiltration on postoperative pain and on postoperative opioid consumption. All subjects received intraoperative infiltration followed by 5 postoperative injections in 10-hour intervals through a multi-holed catheter placed at the surgical site. 26 patients received ropivacaine and 27 received saline. The intervention period was 2 days and the observational period was 4 days. All subjects received patient-controlled opioid analgesia without any restrictions on the total daily dose. Pain was assessed at specific postoperative time points and the daily opioid usage was registered.
Infiltration with 75 mL (150 mg) of ropivacaine did not reduce postoperative pain or opioid requirements during the first 4 days.
The clinical importance of ropivacaine as single component in postoperative treatment of pain is questionable, and we are planning further studies to explore the potential of LIA in larger volume—and also a multimodal regimen—to treat pain in this category of patients.
PMCID: PMC3967255  PMID: 24650022
13.  The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol 
Surgical treatment of osteoarthritis with total knee arthroplasty (TKA) usually takes place in a complete bloodless field using a tourniquet. However, doing the surgery without a tourniquet may reduce muscle damage, post-surgery pain and led to improved functional rehabilitation and mobilization.
A prospective, blinded, parallel-group, controlled superiority trial, with balanced randomization [1:1]. Patients aged 50 or older eligible for primary TKA for osteoarthritis will be consecutively recruited from Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark. A total of 80 patients will be randomly allocated to TKA with or without tourniquet application providing 40 patients for each of the two treatment arms. The tourniquet assisted TKA group will have an automatic, micro-processor-based pneumatic tourniquet inflated around the thigh during surgery. The non-tourniquet assisted TKA group will have surgery performed without application of a tourniquet. The primary aim is to compare tourniquet assisted to non-tourniquet assisted TKA on patient-reported physical function (KOOS-ADL). The secondary aim is to compare post-surgery pain, function in sports and recreation, quality of life, and performance-based physical function. The explorative outcomes include; use of pain medication, single-fiber muscle damage, and changes in mechanical muscle function. The primary endpoint will be at 3-months following surgical treatment, and the time-point for analysis of the primary outcome. However, follow-up will continue up to 1 year, and provide medium-term results. The treatment effect (difference in KOOS-ADL) will be analyzed using a random effects regression model, crude and adjusted results will be reported, if needed. Analyses will be based on the intention-to-treat (ITT). Subsequent per-protocol analysis may be necessary in the event of a substantial number of patients (> 15%) being lost during follow-up. The number needed to treat (NNT) for a positive effect of treatment (>10 points on KOOS-ADL) will be reported.
This is the first randomized clinical trial comparing the efficacy of tourniquet assisted TKA on patient-reported physical function supported by a range of performance-based secondary outcome measures. As such it will provide high quality evidence that may help determine whether tourniquet should be used in future TKA procedures in patients with osteoarthritis of the knee.
Trial registration
ClinicalTrials NCT01891266.
PMCID: PMC3978123  PMID: 24678741
Tourniquet; Total knee arthroplasty; Patient-reported; Performance-based; Physical function
14.  Low validity of the Sensewear Pro3 activity monitor compared to indirect calorimetry during simulated free living in patients with osteoarthritis of the hip 
To validate physical activity estimates by the Sensewear Pro3 activity monitor compared with indirect calorimetry during simulated free living in patients diagnosed with osteoarthritis of the hip pre or post total hip arthroplasty.
Twenty patients diagnosed with hip osteoarthritis (10 pre- and 10 post total hip arthroplasty; 40% female; age: 63.3 ± 9.0; BMI: 23.7 ± 3.7). All patients completed a 2 hour protocol of simulated free living with 8 different typical physical activity types. Energy consumption (kcal/min) was estimated by the Sense Wear pro3 Armband activity monitor and validated against indirect calorimetry (criterion method) by means of a portable unit (Cosmed K4b2). Bias and variance was analyzed using functional ANOVA.
Mean bias during all activities was 1.5 Kcal/min 95%CI [1.3; 1.8] corresponding to 72% (overestimation). Normal gait speed showed an overestimation of 2.8 Kcal/min, 95%CI [2.3; 3.3] (93%) while an underestimation of -1.1 Kcal/min, 95%CI [-1.8; -0.3] (-25%) was recorded during stair climb. Activities dominated by upper body movements showed large overestimation with 4.37 Kcal/min, 95%CI [3.8; 5.1] (170%) being recorded during gardening. Both bias and variance appeared to be dependent on activity type.
The activity monitor generally overestimated the energy consumption during common activities of low to medium intensity in the patient group. The size and direction of the bias was highly dependent on the activity type which indicates the activity monitor is of limited value in patients with hip osteoarthritis and that the results do not express the real energy expenditure.
PMCID: PMC3938645  PMID: 24552503
15.  Heritability of clubfoot: a twin study 
The aetiology of congenital clubfoot is unclear. Although studies on populations, families, and twins suggest a genetic component to the aetiology, other studies have identified environmental factors. The purpose of this study was to calculate heritability in order to determine to what extent genetic and/or environmental factors contribute to the aetiology of congenital clubfoot and to asses whether there was a change in the prevalence over time.
Materials and Methods
The Odense based Danish Twin Registry is unique as it contains data on all the approximately 85,000 twin pairs born in Denmark over the last 140 years. All 46,418 twin individuals born from 1931 through 1982, who had earlier consented to contact, received a 17-page Omnibus questionnaire in the spring of 2002. Data were analysed with structural equation models to identify the best fitting aetiological model based on a balance of goodness-of-fit and parsimony and to estimate heritability.
We found an overall self-reported prevalence of congenital clubfoot of 0.0027 (95 % confidence interval 0.0022–0.0034). Fifty-five complete (both twins answered the question) twin pairs were identified representing 12 monozygotic, 22 same-sex dizygotic, 18 opposite-sex dizygotic, and 3 with unclassified zygosity. The model with only environmental factors (CE) was best fitting based on AIC, and the model with an additive genetic factor (ACE) came in second. Due to the small statistical power, we hypothesise that the model with both genetic and environmental effects (ACE) was the better model. Choosing the ACE-model we found a heritability of clubfoot of 30 %. Regression coefficient for age was −0.002 (−0.011 to 0.005), indicating that there has been no change in prevalence of clubfoot over the 50-year age span we examined.
We conclude that non-genetic factors must play a role, and a genetic factor might contribute, in the aetiology of congenital clubfoot.
PMCID: PMC3935025  PMID: 24504418
Clubfoot; Twins; Heritability; Genetics; Aetiology
16.  Increased risk of revision in patients with non-traumatic femoral head necrosis 
Acta Orthopaedica  2014;85(1):11-17.
Background and purpose
Previous studies of patients who have undergone total hip arthroplasty (THA) due to femoral head necrosis (FHN) have shown an increased risk of revision compared to cases with primary osteoarthritis (POA), but recent studies have suggested that this procedure is not associated with poor outcome. We compared the risk of revision after operation with THA due to FHN or POA in the Nordic Arthroplasty Register Association (NARA) database including Denmark, Finland, Norway, and Sweden.
Patients and methods
427,806 THAs performed between 1995 and 2011 were included. The relative risk of revision for any reason, for aseptic loosening, dislocation, deep infection, and periprosthetic fracture was studied before and after adjustment for covariates using Cox regression models.
416,217 hips with POA (mean age 69 (SD 10), 59% females) and 11,589 with FHN (mean age 65 (SD 16), 58% females) were registered. The mean follow-up was 6.3 (SD 4.3) years. After 2 years of observation, 1.7% in the POA group and 3.0% in the FHN group had been revised. The corresponding proportions after 16 years of observation were 4.2% and 6.1%, respectively. The 16-year survival in the 2 groups was 86% (95% CI: 86–86) and 77% (CI: 74–80). After adjusting for covariates, the relative risk (RR) of revision for any reason was higher in patients with FHN for both periods studied (up to 2 years: RR = 1.44, 95% CI: 1.34–1.54; p < 0.001; and 2–16 years: RR = 1.25, 1.14–1.38; p < 0.001).
Patients with FHN had an overall increased risk of revision. This increased risk persisted over the entire period of observation and covered more or less all of the 4 most common reasons for revision.
PMCID: PMC3940986  PMID: 24359026
17.  Minimal clinically important improvement (MCII) and patient-acceptable symptom state (PASS) in total hip arthroplasty (THA) patients 1 year postoperatively 
Acta Orthopaedica  2014;85(1):39-48.
Background and purpose
The increased use of patient-reported outcomes (PROs) in orthopedics requires data on estimated minimal clinically important improvements (MCIIs) and patient-acceptable symptom states (PASSs). We wanted to find cut-points corresponding to minimal clinically important PRO change score and the acceptable postoperative PRO score, by estimating MCII and PASS 1 year after total hip arthroplasty (THA) for the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) and the EQ-5D.
Patients and methods
THA patients from 16 different departments received 2 PROs and additional questions preoperatively and 1 year postoperatively. The PROs included were the HOOS subscales pain (HOOS Pain), physical function short form (HOOS-PS), and hip-related quality of life (HOOS QoL), and the EQ-5D. MCII and PASS were estimated using multiple anchor-based approaches.
Of 1,837 patients available, 1,335 answered the preoperative PROs, and 1,288 of them answered the 1-year follow-up. The MCIIs and PASSs were estimated to be: 24 and 91 (HOOS Pain), 23 and 88 (HOOS-PS), 17 and 83 (HOOS QoL), 0.31 and 0.92 (EQ-5D Index), and 23 and 85 (EQ-VAS), respectively. MCIIs corresponded to a 38–55% improvement from mean baseline PRO score and PASSs corresponded to absolute follow-up scores of 57–91% of the maximum score in THA patients 1 year after surgery.
This study improves the interpretability of PRO scores. The different estimation approaches presented may serve as a guide for future MCII and PASS estimations in other contexts. The cutoff points may serve as reference values in registry settings.
PMCID: PMC3940990  PMID: 24286564
18.  Low bone mineral density is not related to failure in femoral neck fracture patients treated with internal fixation 
Acta Orthopaedica  2014;85(1):60-65.
Background and purpose
Internal fixation (IF) in femoral neck fractures has high reoperation rates and some predictors of failure are known, such as age, quality of reduction, and implant positioning. Finding new predictors of failure is an ongoing process, and in this study we evaluated the importance of low bone mineral density (BMD).
Patients and methods
140 consecutive patients (105 females, median age 80) treated with IF had a dual-energy X-ray absorptiometry (DXA) scan of the hip performed median 80 days after treatment. The patients’ radiographs were evaluated for fracture displacement, implant positioning, and quality of reduction. From a questionnaire completed during admission, 2 variables for comorbidity and walking disability were chosen.
Primary outcome was low hip BMD (amount of mineral matter per square centimeter of hip bone) compared to hip failure (resection, arthroplasty, or new hip fracture). A stratified Cox regression model on fracture displacement was applied and adjusted for age, sex, quality of reduction, implant positioning, comorbidity, and walking disability.
49 patients had a T-score below –2.5 (standard deviation from the young normal reference mean) and 70 patients had a failure. The failure rate after 2 years was 22% (95% CI: 12–39) for the undisplaced fractures and 66% (CI: 56–76) for the displaced fractures. Cox regression showed no association between low hip BMD and failure. For the covariates, only implant positioning showed an association with failure.
We found no statistically significant association between low hip BMD and fixation failure in femoral neck fracture patients treated with IF.
PMCID: PMC3940993  PMID: 24359030
19.  Factors influencing health-related quality of life after total hip replacement - a comparison of data from the Swedish and Danish hip arthroplasty registers 
There is an increasing focus on measuring patient-reported outcomes (PROs) as part of routine medical practice, particularly in fields such as joint replacement surgery where pain relief and improvement in health-related quality of life (HRQoL) are primary outcomes. Between-country comparisons of PROs may present difficulties due to cultural differences and differences in the provision of health care. However, in order to understand how these differences affect PROs, common predictors for poor and good outcomes need to be investigated. This cross-sectional study investigates factors influencing health-related quality of life (HRQoL) one year after total hip replacement (THR) surgery in Sweden and in Denmark.
Data was retrieved from the Swedish (n = 14 560 patients) and Danish (n = 632 patients) Hip Arthroplasty Registers according to preset selection criteria. Using linear regression models, we examined how sex, age, comorbidity and country of surgery were associated with different aspects of HRQoL as measured by the EQ-5D index and EQ VAS.
Danish patients had an overall higher EQ-5D index and EQ VAS than Swedish patients (p < 0.001). After regression analysis, the estimated coefficients for sex, age, or the Charlson score did not differ between countries for either the EQ-5D index (p = 0.83) or EQ VAS (p = 0.41) one year after THR.
We conclude that there are clear similarities in how basic predictors influence patient-reported outcomes (PROs) in patients with THR in Sweden and Denmark and these known predictors of good or poor HRQoL outcomes are not specific for each country.
PMCID: PMC4228371  PMID: 24192304
Total hip replacement; EQ-5D; Predictors; Comorbidity; Patient-reported outcome; Patient-reported outcome measures; Register study
20.  Effects of a perfusion bioreactor activated novel bone substitute in spine fusion in sheep 
European Spine Journal  2012;21(9):1740-1747.
To evaluate the effect of a large perfusion-bioreactor cell-activated bone substitute, on a two-level large posterolateral spine fusion sheep model.
A 50 mm long porous biphasic-calcium–phosphate bone substitute reinforced with poly(d,l-lactide) and, activated with bone marrow derived mononuclear-cells (BMNC) was used. Eighteen sheep were divided into two groups and one group (n = 9) had BMNC-activated bone substitutes and cell-free substitutes implanted. The second group (n = 9) had autograft supplemented with BMNC and regular autograft implanted. The implant material was alternated between spine level L2–L3 and L4–L5 in both groups. MicroCT was used to compare the spine fusion efficacy and bone structure of the two groups as well as the implanted bone substitutes and non-implanted substitutes.
After 4½ months six sheep survived in both groups and we found five spine levels were fused when using activated bone substitute compared to three levels with cell-free bone substitute (p = 0.25). Five sheep fused at both levels in the autograft group. A significant increased bone density (p < 0.05) and anisotropy (p < 0.05) was found in the group of activated bone substitutes compared to cell-free bone substitute and no difference existed on the other parameters. The implanted bone substitutes had a significant higher bone density and trabecular thickness than non-implanted bone substitutes, thus indicating that the PLA reinforced BCP had osteoconductive properties (p < 0.05). No effect of the supplemented BMNC to autograft was observed. The autograft group had a significant higher bone density, trabecular thickness and degree of anisotropy than the implanted bone substitutes (p < 0.05), but a lower connectivity density existed (p < 0.05). This indicates that though the activated substitute might have a similar fusion efficacy to autograft, the fusion bridge is not of equal substance.
We found that bioreactor-generated cell-based bone substitutes seemed superior in fusion ability when compared to cell-free bone substitute and comparable to autograft in fusion ability, but not in bone structure. This combined with the favorable biocompatible abilities and strength comparable to human cancellous bone indicates that it might be a suitable bone substitute in spine fusion procedures.
PMCID: PMC3459119  PMID: 22777077
Bone graft substitute; Poly(d,l-lactide) enhanced hydroxyappatite/β-tricalciumphosphate; Perfusion bioreactor; Posterolateral spine fusion; Microarchitecture
21.  Similar range of motion and function after resurfacing large–head or standard total hip arthroplasty 
Acta Orthopaedica  2013;84(3):246-253.
Background and purpose
Large–size hip articulations may improve range of motion (ROM) and function compared to a 28–mm THA, and the low risk of dislocation allows the patients more activity postoperatively. On the other hand, the greater extent of surgery for resurfacing hip arthroplasty (RHA) could impair rehabilitation. We investigated the effect of head size and surgical procedure on postoperative rehabilitation in a randomized clinical trial (RCT).
We followed randomized groups of RHAs, large–head THAs and standard THAs at 2 months, 6 months, 1 and 2 years postoperatively, recording clinical rehabilitation parameters.
Large articulations increased the mean total range of motion by 13° during the first 6 postoperative months. The increase was not statistically significant and was transient. The 2–year total ROM (SD) for RHA, standard THA, and large–head THA was 221° (35), 232° (36), and 225° (30) respectively, but the differences were not statistically significant. The 3 groups were similar regarding Harris hip score, UCLA activity score, step rate, and sick leave.
Head size had no influence on range of motion. The lack of restriction allowed for large articulations did not improve the clinical and patient–perceived outcomes. The more extensive surgical procedure of RHA did not impair the rehabilitation.
This project is registered at under # NCT01113762.
PMCID: PMC3715815  PMID: 23530872
22.  Lower reoperation rate for cemented hemiarthroplasty than for uncemented hemiarthroplasty and internal fixation following femoral neck fracture 
Acta Orthopaedica  2013;84(3):254-259.
Background and purpose
Elderly patients with displaced femoral neck fractures are commonly treated with a hemiarthroplasty (HA), but little is known about the long-term failure of this treatment. We compared reoperation rates for patients aged at least 75 years with displaced femoral neck fractures treated with either internal fixation (IF), cemented HA, or uncemented HA (with or without hydroxyapatite coating), after 12–19 years of follow-up.
4 hospitals with clearly defined guidelines for the treatment of 75+ year-old patients with a displaced femoral neck fracture were included. Cohort 1 (1991–1993) with 180 patients had undergone IF; cohort 2 (1991–1995) with 203 patients had received an uncemented bipolar Ultima HA stem (Austin-Moore); cohort 3 (1991–1995) with 209 patients had received a cemented Charnley-Hastings HA; and cohort 4 (1991–1998) with 158 patients had received an uncemented hydroxyapatite-coated Furlong HA. Data were retrieved from patient files, from the region-based patient administrative system, and from the National Registry of Patients at the end of 2010. We performed survival analysis with adjustment for comorbidity, age, and sex.
Cemented HA had a reoperation rate (RR) of 5% and was used as reference in the Cox regression analysis, which showed significantly higher hazard ratios (HRs) for IF (HR = 3.8, 95% CI: 1.9–7.5; RR = 18%), uncemented HA (HR = 2.2, CI: 1.1–4.5; RR = 11%) and uncemented hydroxyapatite-coated HA (HR = 3.6, CI: 1.8–7.4; RR = 16%).
Cemented HA has a superior long-term hip survival rate compared to IF and uncemented HA (with and without hydroxyapatite coating) in patients aged 75 years or more with displaced femoral neck fractures.
PMCID: PMC3715822  PMID: 23594248
23.  The effect of education and supervised exercise vs. education alone on the time to total hip replacement in patients with severe hip osteoarthritis. A randomized clinical trial protocol 
The age- and gender-specific incidence of total hip replacement surgery has increased over the last two decades in all age groups. Recent studies indicate that non-surgical interventions are effective in reducing pain and disability, even at later stages of the disease when joint replacement is considered. We hypothesize that the time to hip replacement can be postponed in patients with severe hip osteoarthritis following participation in a patient education and supervised exercise program when compared to patients receiving patient education alone.
A prospective, blinded, parallel-group multi-center trial (2 sites), with balanced randomization [1:1]. Patients with hip osteoarthritis and an indication for hip replacement surgery, aged 40 years and above, will be consecutively recruited and randomized into two treatment groups. The active treatment group will receive 3 months of supervised exercise consisting of 12 sessions of individualized, goal-based neuromuscular training, and 12 sessions of intensive resistance training plus patient education (3 sessions). The control group will receive only patient education (3 sessions). The primary end-point for assessing the effectiveness of the intervention is 12 months after baseline. However, follow-ups will also be performed once a year for at least 5 years. The primary outcome measure is the time to hip replacement surgery measured on a Kaplain-Meier survival curve from time of inclusion. Secondary outcome measures are the five subscales of the Hip disability and Osteoarthritis Outcome Score, physical activity level (UCLA activity score), and patient’s global perceived effect. Other measures include pain after exercise, joint-specific adverse events, exercise adherence, general health status (EQ-5D-5L), mechanical muscle strength and performance in physical tests. A cost-effectiveness analysis will also be performed.
To our knowledge, this is the first randomized clinical trial comparing a patient education plus supervised exercise program to patient education alone in hip osteoarthritis patients with an indication for surgery on the time to total hip replacement.
Trial registration
PMCID: PMC3561107  PMID: 23311889
Exercise therapy; Education; Osteoarthritis; Hip; Hip replacement
24.  Reproducibility of range of motion and muscle strength measurements in patients with hip osteoarthritis – an inter-rater study 
Assessment of range of motion (ROM) and muscle strength is fundamental in the clinical diagnosis of hip osteoarthritis (OA) but reproducibility of these measurements has mostly involved clinicians from secondary care and has rarely reported agreement parameters. Therefore, the primary objective of the study was to determine the inter-rater reproducibility of ROM and muscle strength measurements. Furthermore, the reliability of the overall assessment of clinical hip OA was evaluated. Reporting is in accordance with proposed guidelines for the reporting of reliability and agreement studies (GRRAS).
In a university hospital, four blinded raters independently examined patients with unilateral hip OA; two hospital orthopaedists independently examined 48 (24 men) patients and two primary care chiropractors examined 61 patients (29 men). ROM was measured in degrees (deg.) with a standard two-arm goniometer and muscle strength in Newton (N) using a hand-held dynamometer. Reproducibility is reported as agreement and reliability between paired raters of the same profession. Agreement is reported as limits of agreement (LoA) and reliability is reported with intraclass correlation coefficients (ICC). Reliability of the overall assessment of clinical OA is reported as weighted kappa.
Between orthopaedists, agreement for ROM ranged from LoA [-28–12 deg.] for internal rotation to [-8–13 deg.] for extension. ICC ranged between 0.53 and 0.73, highest for flexion. For muscle strength between orthopaedists, LoA ranged from [-65–47N] for external rotation to [-10 –59N] for flexion. ICC ranged between 0.52 and 0.85, highest for abduction. Between chiropractors, agreement for ROM ranged from LoA [-25–30 deg.] for internal rotation to [-13–21 deg.] for flexion. ICC ranged between 0.14 and 0.79, highest for flexion. For muscle strength between chiropractors, LoA ranged between [-80–20N] for external rotation to [-146–55N] for abduction. ICC ranged between 0.38 and 0.81, highest for flexion. Weighted kappa for the overall assessment of clinical hip OA was 0.52 between orthopaedists and 0.65 between chiropractors.
Reproducibility of goniometric and dynamometric measurements of ROM and muscle strength in patients with hip OA is poor between experienced orthopaedists and between experienced chiropractors. Orthopaedists and chiropractors can to a moderate degree differentiate between hips with or without osteoarthritis.
PMCID: PMC3565957  PMID: 23217149
Hip; Examination; Inter-observer; Reliability; Osteoarthritis; Hip
25.  Low revision rate after total hip arthroplasty in patients with pediatric hip diseases 
Acta Orthopaedica  2012;83(5):436-441.
The results of primary total hip arthroplasties (THAs) after pediatric hip diseases such as developmental dysplasia of the hip (DDH), slipped capital femoral epiphysis (SCFE), or Perthes’ disease have been reported to be inferior to the results after primary osteoarthritis of the hip (OA).
Materials and methods
We compared the survival of primary THAs performed during the period 1995–2009 due to previous DDH, SCFE, Perthes’ disease, or primary OA, using merged individual-based data from the Danish, Norwegian, and Swedish arthroplasty registers, called the Nordic Arthroplasty Register Association (NARA). Cox multiple regression, with adjustment for age, sex, and type of fixation of the prosthesis was used to calculate the survival of the prostheses and the relative revision risks.
370,630 primary THAs were reported to these national registers for 1995–2009. Of these, 14,403 THAs (3.9%) were operated due to pediatric hip diseases (3.1% for Denmark, 8.8% for Norway, and 1.9% for Sweden) and 288,435 THAs (77.8%) were operated due to OA. Unadjusted 10-year Kaplan-Meier survival of THAs after pediatric hip diseases (94.7% survival) was inferior to that after OA (96.6% survival). Consequently, an increased risk of revision for hips with a previous pediatric hip disease was seen (risk ratio (RR) 1.4, 95% CI: 1.3–1.5). However, after adjustment for differences in sex and age of the patients, and in fixation of the prostheses, no difference in survival was found (93.6% after pediatric hip diseases and 93.8% after OA) (RR 1.0, CI: 1.0–1.1). Nevertheless, during the first 6 postoperative months more revisions were reported for THAs secondary to pediatric hip diseases (RR 1.2, CI: 1.0–1.5), mainly due to there being more revisions for dislocations (RR 1.8, CI: 1.4–2.3). Comparison between the different diagnosis groups showed that the overall risk of revision after DDH was higher than after OA (RR 1.1, CI: 1.0–1.2), whereas the combined group Perthes’ disease/SCFE did not have a significantly different risk of revision to that of OA (RR 0.9, CI: 0.7–1.0), but had a lower risk than after DDH (RR 0.8, CI: 0.7–1.0).
After adjustment for differences in age, sex, and type of fixation of the prosthesis, no difference in risk of revision was found for primary THAs performed due to pediatric hip diseases and those performed due to primary OA.
PMCID: PMC3488168  PMID: 23043269

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