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1.  Prognostic factors for local recurrence and mortality in adult soft tissue sarcoma of the extremities and trunk wall 
Acta Orthopaedica  2014;85(3):323-332.
Background and purpose
Previous studies of soft tissue sarcoma (STS) have identified a number of possible prognostic factors; however, the majority of these include highly selected populations, with unclear validation of data and insufficient statistical methods. We identified prognostic factors in a validated, population-based 30-year series of STS treated at a single institution, using an advanced statistical approach.
Patients and methods
Between 1979 and 2008, 922 adult patients from western Denmark were treated at the Aarhus Sarcoma Center for non-metastatic STS in the extremities or trunk. The endpoints were local recurrence (LR) and disease-specific mortality (DSM). Prognostic factors were analyzed using a proportional hazard model, including continuous variables as cubic splines. Directed acyclic graphs were used to depict the causal structure.
Results
The 5-year LR was 16% and the 5-year DSM was 24%. Important prognostic factors for both LR and DSM were age, duration of symptoms, tumor size, grade, margin, and radiotherapy, while anatomical location (upper, lower extremity, trunk) was prognostic for DSM.
Interpretation
In this population-based series of adult, non-metastatic STS, we included directed acyclic graphs, cubic splines, and a competing risk model in order to minimize bias, and demonstrated that these statistical methods are feasible. Using these statistical methods on a large, validated dataset, we excluded depth as a prognostic factor and established that age, duration of symptoms, size, grade, margin, and radiotherapy were important prognostic factors for both local recurrence and disease-specific mortality.
doi:10.3109/17453674.2014.908341
PMCID: PMC4062802  PMID: 24694277
2.  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.
Results
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.
Interpretation
The differences in THR survival rates were considerable, with inferior results in Finland. Brand-level comparison of THRs in Nordic countries will be required.
doi:10.3109/17453674.2014.893498
PMCID: PMC3967250  PMID: 24650019
3.  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.
Results
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).
Interpretation
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.
doi:10.3109/17453674.2013.874927
PMCID: PMC3940986  PMID: 24359026
4.  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.
Results
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.
Interpretation
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.
doi:10.3109/17453674.2013.867782
PMCID: PMC3940990  PMID: 24286564
5.  Low revision rate after total hip arthroplasty in patients with pediatric hip diseases 
Acta Orthopaedica  2012;83(5):436-441.
Background
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.
Results
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).
Interpretation
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.
doi:10.3109/17453674.2012.736171
PMCID: PMC3488168  PMID: 23043269
6.  Increasing risk of prosthetic joint infection after total hip arthroplasty 
Acta Orthopaedica  2012;83(5):449-458.
Background and purpose
The risk of revision due to infection after primary total hip arthroplasty (THA) has been reported to be increasing in Norway. We investigated whether this increase is a common feature in the Nordic countries (Denmark, Finland, Norway, and Sweden).
Materials and methods
The study was based on the Nordic Arthroplasty Register Association (NARA) dataset. 432,168 primary THAs from 1995 to 2009 were included (Denmark: 83,853, Finland 78,106, Norway 88,455, and Sweden 181,754). Adjusted survival analyses were performed using Cox regression models with revision due to infection as the endpoint. The effect of risk factors such as the year of surgery, age, sex, diagnosis, type of prosthesis, and fixation were assessed.
Results
2,778 (0.6%) of the primary THAs were revised due to infection. Compared to the period 1995–1999, the relative risk (with 95% CI) of revision due to infection was 1.1 (1.0–1.2) in 2000–2004 and 1.6 (1.4–1.7) in 2005–2009. Adjusted cumulative 5–year revision rates due to infection were 0.46% (0.42–0.50) in 1995–1999, 0.54% (0.50–0.58) in 2000–2004, and 0.71% (0.66–0.76) in 2005–2009. The entire increase in risk of revision due to infection was within 1 year of primary surgery, and most notably in the first 3 months. The risk of revision due to infection increased in all 4 countries. Risk factors for revision due to infection were male sex, hybrid fixation, cement without antibiotics, and THA performed due to inflammatory disease, hip fracture, or femoral head necrosis. None of these risk factors increased in incidence during the study period.
Interpretation
We found increased relative risk of revision and increased cumulative 5–year revision rates due to infection after primary THA during the period 1995–2009. No change in risk factors in the NARA dataset could explain this increase. We believe that there has been an actual increase in the incidence of prosthetic joint infections after THA.
doi:10.3109/17453674.2012.733918
PMCID: PMC3488170  PMID: 23083433
7.  Feasibility of 4 patient-reported outcome measures in a registry setting 
Acta Orthopaedica  2012;83(4):321-327.
Background and purpose
Feasibility is an important parameter when choosing which patient-reported outcomes (PRO) to use in a study. We assessed the feasibility of PROs in a hip registry setting.
Methods
Primary total hip arthroplasty (THA) patients (n = 5,747) who had been operated on 1–2, 5–6, or 10–11 years previously were randomly selected from the Danish Hip Arthroplasty Register and sent 2 PRO questionnaires: 1 generic (EuroQoL-5D or SF-12 health survey) and 1 disease-specific (hip dysfunction and osteoarthritis outcome score (HOOS) or Oxford 12-item hip score). We compared response rates, floor and ceiling effects, missing items, and the need for manual validation of forms.
Results
4,784 patients (mean age 71 years, 57% females) were included (83%). The response rates ranged from 82–84%. Statistically significantly different floor and ceiling effects ranged from 0% to 0.5% and from 6.1% to 46%, respectively. Missing items ranged from 1.2% to 3.4%, and 0.8–4.3% required manual validation (p < 0.009). A hypothetical repeat study found that group sizes from 51 to 1,566 are needed for subgroup analysis, depending on descriptive factor and choice of PRO.
Interpretation
All 4 PROs fulfilled a priori set criteria, with the exception of ceiling effects. The high ceiling effects were attributed to postoperative administration and good outcome for THA. We conclude that all 4 PROs are appropriate for administration in a hip registry.
doi:10.3109/17453674.2012.702390
PMCID: PMC3427620  PMID: 22900909
8.  Inferior outcome after hip resurfacing arthroplasty than after conventional arthroplasty 
Acta Orthopaedica  2010;81(5):535-541.
Background and purpose
The reported outcomes of hip resurfacing arthroplasty (HRA) vary. The frequency of this procedure in Denmark, Norway, and Sweden is low. We therefore determined the outcome of HRA in the NARA database, which is common to all 3 countries, and compared it to the outcome of conventional total hip arthroplasty (THA).
Methods
The risk of non-septic revision within 2 years was analyzed in 1,638 HRAs and compared to that for 172,554 conventional total hip arthroplasties (THAs), using Cox regression models. We calculated relative risk (RR) of revision and 95% confidence interval.
Results
HRA had an almost 3-fold increased revision risk compared to THA (RR = 2.7, 95% CI: 1.9–3.7). The difference was even greater when HRA was compared to the THA subgroup of cemented THAs (RR = 3.8, CI: 2.7–5.3). For men below 50 years of age, this difference was less pronounced (HRA vs. THA: RR = 1.9, CI: 1.0–3.9; HRA vs. cemented THA: RR = 2.4, CI: 1.1–5.3), but it was even more pronounced in women of the same age group (HRA vs. THA: RR = 4.7, CI: 2.6–8.5; HRA vs. cemented THA: RR = 7.4, CI: 3.7–15). Within the HRA group, risk of non-septic revision was reduced in hospitals performing ≥ 70 HRAs annually (RR = 0.3, CI: 0.1–0.7) and with use of Birmingham hip resurfacing (BHR) rather than the other designs as a group (RR = 0.3, CI: 0.1–0.7). Risk of early revision was also reduced in males (RR = 0.5, CI: 0.2–0.9). The femoral head diameter alone had no statistically significant influence on the early revision rate, but it eliminated the significance of male sex in a combined analysis.
Interpretation
In general, our results do not support continued use of hip resurfacing arthroplasty. Men had a lower early revision rate, which was still higher than observed for all-cemented hips. Further follow-up is necessary to determine whether HRA might be useful as an alternative in males.
doi:10.3109/17453674.2010.525193
PMCID: PMC3214740  PMID: 20919812
9.  Risk factors for revision due to infection after primary total hip arthroplasty 
Acta Orthopaedica  2010;81(5):542-547.
Background and purpose
There has been a limited amount of research on risk factors for revision due to infection following total hip arthroplasty (THA), probably due to low absolute numbers of revisions. We therefore studied patient- and surgery-related risk factors for revision due to infection after primary THA in a population-based setting.
Materials and methods
Using the Danish Hip Arthroplasty Registry, we identified 80,756 primary THAs performed in Denmark between Jan 1, 1995 and Dec 31, 2008. We used Cox regression analysis to compute crude and adjusted relative risk (RR) of revision due to infection. Revision was defined as extraction or exchange of any component due to infection. The median follow-up time was 5 (0–14) years.
Results
597 primary THAs (0.7%) were revised due to infection. Males, patients with any co-morbidity, patients operated due to non-traumatic avascular femoral head necrosis, and patients with long duration of surgery had an increased RR of revision due to infection within the total follow-up time. A tendency of increased RR of revision was found for patients who had received cemented THA without antibiotic and hybrid THA relative to patients with cementless implants. Hip diagnosis and fixation technique were not associated with risk of revision due to infection within 1 year of surgery (short-term risk).
Interpretation
We identified several categories of THA patients who had a higher risk of revision due to infection. Further research is required to explain the mechanism underlying this increased risk. More attention should be paid by clinicians to infection prevention strategies in patients with THA, particularly those with increased risk.
doi:10.3109/17453674.2010.519908
PMCID: PMC3214741  PMID: 20860453
10.  Survival of primary total hip arthroplasty in rheumatoid arthritis patients 
Acta Orthopaedica  2010;81(1):60-65.
Background and purpose
There has been a limited amount of research on survival of total hip arthroplasties (THAs) in rheumatoid arthritis (RA). We therefore performed a population-based, nationwide study to compare the survival of primary THAs in RA patients and in osteoarthritis (OA) patients. We also wanted to identify predictors of THA failure in RA patients.
Methods
Using the Danish Hip Arthroplasty Registry, we identified 1,661 primary THAs in RA patients and 64,858 in OA patients, all of which were inserted between 1995 and 2008. The follow-up period was up to 14 years for both groups.
Results
Regarding overall THA survival, the adjusted RR for RA patients compared to OA patients was 0.81 (95% CI: 0.65–1.01). We found no difference in survival of cups between primary THAs in RA and OA patients. In contrast, there was better overall survival of stems in RA patients than in OA patients, both regarding revision due to aseptic loosening (adjusted RR = 0.58; 95% CI: 0.34–0.99) and for any reason (adjusted RR = 0.63; 95% CI: 0.45–0.88). In RA patients, males had a higher risk of revision than females concerning aseptic loosening of the stem, any revision of the stem, and any revision of both components.
Interpretation
The overall survival of primary THAs in RA patients is similar to THA survival in OA patients. Stem survival appeared to be better in RA patients, while survival of the total THA concept did not show any statistically significant differences between the two groups. In RA patients, males appear to have a greater risk of revision than females.
doi:10.3109/17453671003685418
PMCID: PMC2856205  PMID: 20180721
11.  The Nordic Arthroplasty Register Association 
Acta Orthopaedica  2009;80(4):393-401.
Background and purpose The possibility of comparing results and of pooling the data has been limited for the Nordic arthroplasty registries, because of different registration systems and questionnaires. We have established a common Nordic database, in order to compare demographics and the results of total hip replacement surgery between countries. In addition, we plan to study results in patient groups in which the numbers are too small to be studied in the individual countries.
Material and methods Primary total hip replacements (THRs) from 1995–2006 were selected for the study. Denmark, Sweden, and Norway contributed data. A common code set was made and Cox multiple regression, with adjustment for age, sex, and diagnosis was used to calculate prosthesis survival with any revision as endpoint.
Results 280,201 operations were included (69,242 from Denmark, 140,821 from Sweden, and 70,138 from Norway). Females accounted for 60% of the patients in Denmark and Sweden, and 70% in Norway. Childhood disease was the cause of 3.1%, 1.8%, and 8.7% of the operations in Denmark, Sweden, and Norway, respectively. Resurfacing of hips accounted for 0.5% or less in all countries. The posterior approach was used in 91% of cases in Denmark, 60% in Sweden, and 24% in Norway. Cemented THRs were used in 46% of patients in Denmark, in 89% of patients in Sweden, and in 79% of patients in Norway.
Of the 280,201 primary THRs, 9,596 (3.4%) had been revised. 10-year survival was 92% (95% CI: 91.6–92.4) in Denmark, 94% (95% CI: 93.6–94.1) in Sweden, and 93% (95% CI: 92.3–93.0) in Norway. In Denmark, 34% of the revisions were due to dislocation, as compared to 23% in Sweden and Norway. Replacement of only cup or liner constituted 44% of the revisions in Denmark, 29% in Sweden, and 33% in Norway.
Interpretation This unique common Nordic collaboration has shown differences between the countries concerning demographics, prosthesis fixation, and survival. The large number of patients in this database significantly widens our horizons for future research.
doi:10.3109/17453670903039544
PMCID: PMC2823198  PMID: 19513887

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