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Background and purpose — There have been few comparative studies on total knee replacement (TKR) with cemented tibia and uncemented femur (hybrid TKR). Previous studies have not shown any difference in revision rate between cemented and hybrid fixation, but these studies had few hybrid prostheses. We have evaluated the outcome of hybrid TKR based on data from the Norwegian Arthroplasty Register (NAR). Patients and methods — We compared 4,585 hybrid TKRs to 20,095 cemented TKRs with risk of revision for any cause as the primary endpoint. We included primary TKRs without patella resurfacing that were reported to the NAR during the years 1999–2012. To minimize the possible confounding effect of prosthesis brands, only brands that were used both as hybrids and cemented in more than 200 cases were included. Kaplan-Meier survival analysis and Cox regression analysis were done with adjustment for age, sex, and preoperative diagnosis. To include death as a competing risk, cumulative incidence function estimates were calculated. Results — Estimated survival at 11 years was 94.3% (95% CI: 93.9–94.7) in the cemented TKR group and 96.3% (CI: 95.3–97.3) in the hybrid TKR group. The adjusted Cox regression analysis showed a lower risk of revision in the hybrid group (relative risk = 0.58, CI: 0.48–0.72, p < 0.001). The hybrid group included 3 brands of prostheses: LCS classic, LCS complete, and Profix. Profix hybrid TKR had lower risk of revision than cemented TKR, but the LCS classic and LCS complete did not. Kaplan-Meier estimated survival at 11 years was 96.8% (CI: 95.6–98.0) in the hybrid Profix group and 95.2% (CI: 94.6–95.8) in the cemented Profix group. Mean operating time was 17 min longer in the cemented group. Interpretation — Survivorship of the hybrid TKR at 11 years was better than that for cemented TKR, or the same, depending on the brand of prosthesis. Hybrid fixation appears to be a safe and time-efficient alternative to cemented fixation in total knee replacement surgery. publishedVersion

Background and purpose In Norway, the proportion of revision knee arthroplasties increased from 6.9% in 1994 to 8.5% in 2011. However, there is limited information on the epidemiology and causes of subsequent failure of revision knee arthroplasty. We therefore studied survival rate and determined the modes of failure of aseptic revision total knee arthroplasties. Method This study was based on 1,016 aseptic revision total knee arthroplasties reported to the Norwegian Arthroplasty Register between 1994 and 2011. Revisions done for infections were not included. Kaplan-Meier and Cox regression analyses were used to assess the survival rate and the relative risk of re-revision with all causes of re-revision as endpoint. Results 145 knees failed after revision total knee arthroplasty. Deep infection was the most frequent cause of re-revision (28%), followed by instability (26%), loose tibial component (17%), and pain (10%). The cumulative survival rate for revision total knee arthroplasties was 85% at 5 years, 78% at 10 years, and 71% at 15 years. Revision total knee arthroplasties with exchange of the femoral or tibial component exclusively had a higher risk of re-revision (RR = 1.7) than those with exchange of the whole prosthesis. The risk of re-revision was higher for men (RR = 2.0) and for patients aged less than 60 years (RR = 1.6). Interpretation In terms of implant survival, revision of the whole implant was better than revision of 1 component only. Young age and male sex were risk factors for re-revision. Deep infection was the most frequent cause of failure of revision of aseptic total knee arthroplasties.

Background and purpose - Most registry studies regarding highly crosslinked polyethylene (XLPE) have focused on the overall revision risk. We compared the risk of cup and/or liner revision for specific cup and liner designs made of either XLPE or conventional polyethylene (CPE), regarding revision for any reason and revision due to aseptic loosening and/or osteolysis. Patients and methods - Using the Nordic Arthroplasty Register Association (NARA) database, we identified cup and liner designs where either XLPE or CPE had been used in more than 500 THAs performed for primary hip osteoarthritis. We assessed risk of revision for any reason and for aseptic loosening using Cox regression adjusted for age, sex, femoral head material and size, surgical approach, stem fixation, and presence of hydroxyapatite coating (uncemented cups). Results - The CPE version of the ZCA cup had a risk of revision for any reason similar to that of the XLPE version (p = 0.09), but showed a 6-fold higher risk of revision for aseptic loosening (p < 0.001). The CPE version of the Reflection All Poly cup had an 8-fold elevated risk of revision for any reason (p < 0.001) and a 5-fold increased risk of revision for aseptic loosening (p < 0.001). The Charnley Elite Ogee/Marathon cup and the Trilogy cup did not show such differences. Interpretation - Whether XLPE has any advantage over CPE regarding revision risk may depend on the properties of the polyethylene materials being compared, as well as the respective cup designs, fixation type, and follow-up times. Further research is needed to elucidate how cup design factors interact with polyethylene type to affect the risk of revision.

Background and purpose — Given similar functional outcomes with mobile and fixed bearings, a difference in survivorship may favor either. This study investigated the risk of aseptic loosening for the most used subtypes of mobile-bearing rotating-platform knees, in Norway and Australia. Patients and methods — Primary TKRs reported to the Norwegian and Australian joint registries, between 2003 and 2014, were analyzed with aseptic loosening as primary end-point and all revisions as secondary end-point. We hypothesized that no difference would be found in the rate of revision between rotating-platform and the most used fixed-bearing TKRs, or between keeled and non-keeled tibia. Kaplan–Meier estimates and curves, and Cox regression relative risk estimates adjusted for age, sex, and diagnosis were used for comparison. Results — The rotating-platform TKRs had an increased risk of revision for aseptic loosening compared with the most used fixed-bearing knees, in Norway (RR =6, 95% CI 4–8) and Australia (RR =2.1, 95% CI 1.8–2.5). The risk of aseptic loosening as a reason for revision was highest in Norway compared with Australia (RR =1.7, 95% CI 1.4–2.0). The keeled tibial component had the same risk of aseptic loosening as the non-keeled tibia (Australia). Fixation method and subtypes of the tibial components had no impact on the risk of aseptic loosening in these mobile-bearing knees. Interpretation — The rotating-platform TKRs in this study appeared to have a higher risk of revision for aseptic loosening than the most used fixed-bearing TKRs.

Background and purpose - The annual number of total knee arthroplasties (TKAs) has increased worldwide in recent years. To make projections regarding future needs for primaries and revisions, additional knowledge is important. We analyzed and compared the incidences among 4 Nordic countries Patients and methods - Using Nordic Arthroplasty Register Association (NARA) data from 4 countries, we analyzed differences between age and sex groups. We included patients over 30 years of age who were operated with TKA or unicompartmental knee arthroplasty (UKA) during the period 1997-2012. The negative binomial regression model was used to analyze changes in general trends and in sex and age groups. Results - The average annual increase in the incidence of TKA was statistically significant in all countries. The incidence of TKA was higher in women than in men in all 4 countries. It was highest in Finland in patients aged 65 years or more. At the end of the study period in 2012, Finland's total incidence was double that of Norway, 1.3 times that of Sweden and 1.4 times that of Denmark. The incidence was lowest in the youngest age groups (65 years) in all 4 countries. The proportional increase in incidence was highest in patients who were younger than 65 years. Interpretation - The incidence of knee arthroplasty steadily increased in the 4 countries over the study period. The differences between the countries were considerable, with the highest incidence in Finland. Patients aged 65 years or more contributed to most of the total incidence of knee arthroplasty.

Background and purpose — Computer-assisted surgery (CAS) in total knee arthroplasty (TKA) has been used in recent years in the hope of improving the alignment and positioning of the implant, thereby achieving a better functional outcome and durability. However, the role of computer navigation in TKA is still under debate. We used radiostereometric analysis (RSA) in a randomized controlled trial (RCT) to determine whether there are any differences in migration of the tibial component between CAS- and conventionally (CONV-) operated TKA. Patients and methods — 54 patients (CAS, n = 26; CONV, n = 28) with a mean age of 67 (56–78) years and with osteoarthritis or arthritic disease of the knee were recruited from 4 hospitals during the period 2009–2011. To estimate the mechanical stability of the tibial component, the patients were examined with RSA up to 24 months after operation. The following parameters representing tibial component micromotion were measured: 3-D vector of the prosthetic marker that moved the most, representing the magnitude of migration (maximum total point motion, MTPM); the largest negative value for y-translation (subsidence); the largest positive y-translation (lift-off); and prosthetic rotations. The precision of the RSA measurements was evaluated and migration in the 2 groups was compared. Results — Both groups had most migration within the first 3 months, but there was no statistically significant difference in the magnitude of the migration between the CAS group and the CONV group. From 3 to 24 months, the MTPM (in mm) was 0.058 and 0.103 (p = 0.1) for the CAS and CON groups, respectively, and the subsidence (in mm) was 0.005 and 0.011 (p = 0.3). Interpretation — Mean MTPM, subsidence, lift-off, and rotational movement of tibial trays were similar in CAS- and CONV-operated knees. publishedVersion

Background and purpose — Some studies have found high complication rates and others have found low complication rates after unicompartmental knee arthroplasty (UKA). We evaluated whether hospital procedure volume influences the risk of revision using data from the Norwegian Arthroplasty Register (NAR). Materials and methods — 5,791 UKAs have been registered in the Norwegian Arthroplasty Register. We analyzed the 4,460 cemented medial Oxford III implants that were used from 1999 to 2012; this is the most commonly used UKA implant in Norway. Cox regression (adjusted for age, sex, and diagnosis) was used to estimate risk ratios (RRs) for revision. 4 different volume groups were compared: 1–10, 11–20, 21–40, and > 40 UKA procedures annually per hospital. We also analyzed the reasons for revision. Results and interpretation — We found a lower risk of revision in hospitals performing more than 40 procedures a year than in those with less than 10 UKAs a year, with an unadjusted RR of 0.53 (95% CI: 0.35–0.81) and adjusted RR of 0.59 (95% CI: 0.39–0.90). Low-volume hospitals appeared to have a higher risk of revision due to dislocation, instability, malalignment, and fracture than high-volume hospitals. publishedVersion

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.

Background — Hemiarthroplasties are performed in great numbers worldwide but are seldom registered on a national basis. Our aim was to identify risk factors for reoperation after fracturerelated hemiarthroplasty in Norway and Sweden. Material and methods — A common dataset was created based on the Norwegian Hip Fracture Register and the Swedish Hip Arthroplasty Register. 33,205 hip fractures in individuals > 60 years of age treated with modular hemiarthroplasties were reported for the period 2005–2010. Cox regression analyses based on reoperations were performed (covariates: age group, sex, type of stem and implant head, surgical approach, and hospital volume). Results — 1,164 patients (3.5%) were reoperated during a mean follow-up of 2.7 (SD 1.7) years. In patients over 85 years, an increased risk of reoperation was found for uncemented stems (HR = 2.2, 95% CI: 1.7–2.8), bipolar heads (HR = 1.4, CI: 1.2–1.8), posterior approach (HR = 1.4, CI: 1.2–1.8) and male sex (HR = 1.3, CI: 1.0–1.6). For patients aged 75–85 years, uncemented stems (HR = 1.6, 95% CI: 1.2–2.0) and men (HR = 1.3, CI: 1.1–1.6) carried an increased risk. Increased risk of reoperation due to infection was found for patients aged < 75 years (HR = 1.5, CI: 1.1–2.0) and for uncemented stems. For open surgery due to dislocation, the strongest risk factor was a posterior approach (HR = 2.2, CI: 1.8–2.6). Uncemented stems in particular (HR = 3.6, CI: 2.4–5.3) and male sex increased the risk of periprosthetic fracture surgery. Interpretation — Cemented stems and a direct lateral transgluteal approach reduced the risk of reoperation after hip fractures treated with hemiarthroplasty in patients over 75 years. Men and younger patients had a higher risk of reoperation. For the age group 60–74 years, there were no such differences in risk in this material. publishedVersion

The STROBE statement. Description of data: Checklist for reporting observational studies. (PDF 147Â kb)

Descriptive profile of the 5 dimensions of the EQ-5D â different hip fractures. Description of data: Preoperative and postoperative distribution of the descriptive profile of the EQ-5D according to fracture type and length of follow-up. All patients included. (DOCX 18 kb)

Risk of hip replacement (THR) after excluding participants with OA at baseline (n = 5244). Description of data: Results of separate sensitivity analyses. (PDF 298 kb)

Descriptive profile of the 5 dimensions of the EQ-5D â different age groups. Description of data: Preoperative and postoperative distribution of the descriptive profile of the EQ-5D according to age group and length of follow-up. All patients included. (DOCX 21 kb)

Risk of hip replacement (THR) after excluding participants with OA at baseline (n = 5244). Description of data: Results of separate sensitivity analyses. (PDF 298 kb)

Background and purpose The aim of the present study was to assess incidence of and risk factors for infection after hip arthroplasty in data from 3 national health registries. We investigated differences in risk patterns between surgical site infection (SSI) and revision due to infection after primary total hip arthroplasty (THA) and hemiarthroplasty (HA). Materials and methods This observational study was based on prospective data from 2005–2009 on primary THAs and HAs from the Norwegian Arthroplasty Register (NAR), the Norwegian Hip Fracture Register (NHFR), and the Norwegian Surveillance System for Healthcare–Associated Infections (NOIS). The Norwegian Patient Register (NPR) was used for evaluation of case reporting. Cox regression analyses were performed with revision due to infection as endpoint for data from the NAR and the NHFR, and with SSI as the endpoint for data from the NOIS. Results The 1–year incidence of SSI in the NOIS was 3.0% after THA (167/5,540) and 7.3% after HA (103/1,416). The 1–year incidence of revision due to infection was 0.7% for THAs in the NAR (182/24,512) and 1.5% for HAs in the NHFR (128/8,262). Risk factors for SSI after THA were advanced age, ASA class higher than 2, and short duration of surgery. For THA, the risk factors for revision due to infection were male sex, advanced age, ASA class higher than 1, emergency surgery, uncemented fixation, and a National Nosocomial Infection Surveillance (NNIS) risk index of 2 or more. For HAs inserted after fracture, age less than 60 and short duration of surgery were risk factors of revision due to infection. Interpretation The incidences of SSI and revision due to infection after primary hip replacements in Norway are similar to those in other countries. There may be differences in risk pattern between SSI and revision due to infection after arthroplasty. The risk patterns for revision due to infection appear to be different for HA and THA.

Sir—The article “Results of 189 wrist replacements. A report from the Norwegian Arthroplasty Register” by Krukhaug at al. (2011) seems to represent a new trend in the reports of register studies. The advantage of arthroplasty register studies is the comparison of a very high number of implants operated in several clinics and thus, false results from inferior surgical skill and other nonprosthetic factors may be minimized. In the register study by Krukhaug et al. a comparison of three different wrist prostheses with 23, 76, and 90 (84) patients in each group has been carried out (the smallest group includes three different types of a developing prosthesis). This number is far beyond the lowest number of implants reported by any arthroplasty register in the literature. Only 52% of the wrist replacements performed in Norway in the same period was reported to the Arthroplasty Register compared to 99% for knee replacements according to the Norwegian Patient Register. This underreporting of wrist replacements was published by the register already in 2006 (Espehaug et al. 2006). Therefore, it should have been possible for the register to find out what the reason for the discrepancy could be. The authors explain the reason for the underreporting to be that the Norwegian Arthroplasty Register is not so well established among wrist surgeons, but they fail to discuss what importance underreporting has for the results. According to our opinion the low number of patients and the incompleteness of data make the results in the article unreliable. We also mean that studies on so small patient groups as in this article should be carried out in clinical investigations, eventually in cooperation with the arthroplasty register. Compared to the hip the wrist is a complicated joint, and the results after prosthetic replacement is supposed to be inferior. On the other hand the salvage procedure in the wrist is an arthrodesis (Carlson and Simmons 1998), which is not possible in the hip after a failed prosthesis. Krukhaug el al. found a prosthetic survival of 80%, and they conclude that there is no support for widespread implementation of the procedure. Without any documentation in the article, they also claim that the function with prosthesis is not substantially better than with an arthrodesis. We do not agree in this opinion, and we cannot see that the article documents anything about the wrist function after neither a prosthesis nor an arthrodesis. Much higher quality-adjusted life-years are estimated for the patients with an arthroplasty compared to arthrodesis (Cavaliere et al. 2009). Higher quality-adjusted life-years were even estimated in the theoretical extreme situation with all major complications occurring in the arthroplasty patients and no major complications occurring in fused patients. Some patients with a fused wrist have appreciable difficulties with activities of daily living (Sauerbier et al. 2000). Most of the patients with a ruined wrist will prefer mobility in the wrist with a prosthesis when the alternative is an arthrodesis although they know that a failed prosthesis will eventually led to a stiff wrist (Adey et al. 2005). Wrist prostheses have so far been restricted to low demand rheumatoid patients. If the results of this register study are sustainable, Krukhaug et al. are the first authors to document that the outcome of wrist prosthesis in a high demand non rheumatoid group of patients is similar to that of the rheumatoid group. They offer no comment on this finding in the discussion, and there is no explanation why the non rheumatoid patients in the Biax group were excluded from the study. The only increased revision risk the authors found (female), is not discussed although this is different from prosthetic replacements in other joints. Two clinics are responsible for 75% of the reported wrist replacements in the Norwegian Arthroplasty Register. As Krukhaug et al. know, both clinics have their own on-going follow-up studies on these patients. Cooperation with clinics which have experience with wrist replacement and wrist arthrodesis would have improved the quality of the article.

It is envisaged that guidelines for statistical analysis and presentation of results will improve the quality and value of research. The Nordic Arthroplasty Register Association (NARA) has therefore developed guidelines for the statistical analysis of arthroplasty register data. The guidelines are divided into two parts, one with an introduction and a discussion of the background to the guidelines (Ranstam et al. 2011a, see pages x-y in this issue), and this one with a more technical statistical discussion on how specific problems can be handled. This second part contains (1) recommendations for the interpretation of methods used to calculate survival, (2) recommendations on howto deal with bilateral observations, and (3) a discussion of problems and pitfalls associated with analysis of factors that influence survival or comparisons between outcomes extracted from different hospitals.

Background and purpose Resurfacing of the patella during primary total knee arthroplasty (TKA) is often recommended based on higher revision rates in non-resurfaced knees. As many of these revisions are insertions of a patella component due to pain, and since only patients with a non-resurfaced patella have the option of secondary resurfacing, we do not really know whether these patients have more pain and poorer function. The main purpose of the present paper was therefore to assess pain and function at least 2 years after surgery for unrevised primary non-resurfaced and resurfaced TKA, and secondary among prosthesis brands. Methods Information needed to calculate subscales from the knee injury and osteoarthritis outcome score (KOOS) was collected in a questionnaire given to 972 osteoarthritis patients with intact primary TKAs that had been reported to the Norwegian Arthroplasty Register. Pain and satisfaction on visual analog scales and improvement in EQ-5D index score ΔEQ-5D) were also used as outcomes. Outcomes were measured on a scale from 0 to 100 units (worst to best). To estimate differences in mean scores, we used multiple linear regression with adjustment for possible confounders. Results We did not observe any differences between resurfacing and non-resurfacing in any outcome, with estimated differences of ≤ 1.4 units and p-values of > 0.4. There was, however, a tendency of better results for the NexGen implant as compared to the reference brand AGC for symptoms (difference = 4.9, p = 0.05), pain (VAS) (difference = 8.3, p = 0.004), and satisfaction (VAS) (difference = 7.9, p = 0.02). However, none of these differences reached the stated level of minimal perceptible clinical difference. Interpretation Resurfacing of the patella has no clinical effect on pain and function after TKA. Differences between the brands investigated were small and they were assumed to be of minor importance.

Background and purpose Few studies have compared the long-term survival of cemented primary total hip arthroplasties (THAs), and several prostheses have been used without adequate knowledge of their endurance. We studied long-term outcome based on data in the Norwegian Arthroplasty Register. Patients and methods The 10 most used prosthesis brands in 62,305 primary Palacos or Simplex cemented THAs reported to the Register from 1987 through 2007 were included. Survival analyses with revision as endpoint (for any cause or for aseptic loosening) were performed using Kaplan-Meier and multiple Cox regression with time-dependent covariates. Revision rate ratios (RRs) were estimated for the follow-up intervals: 0–5, 6–10, and > 10 years. Results 5 prosthesis brands (cup/stem combinations) (Charnley, Exeter, Titan, Spectron/ITH, Link IP/Lubinus SP; n = 24,728) were investigated with 0–20 year follow-up (inserted 1987–1997). After 18 years, 11% (95% CI: 10.6–12.1) were revised for any cause and 8.4% (7.7–9.1) for aseptic loosening. Beyond 10 years of follow-up, the Charnley cup had a lower revision rate due to aseptic loosening than Exeter (RR = 1.8) and Spectron (RR = 2.4) cups. For stems, beyond 10 years we did not find statistically significant differences comparing Charnley with Titan, ITH, and SP stems, but the Exeter stem had better results (RR = 0.5). 10 prosthesis brands (9 cups in combination with 6 stems; n = 37,577) were investigated with 0–10 years of follow-up (inserted from 1998 through 2007). The Charnley cup had a lower revision rate due to aseptic loosening than all cups except the IP. Beyond 5 years follow-up, the Reflection All-Poly cup had a 14 times higher revision rate. For stems, beyond 5 years the Spectron-EF (RR = 6.1) and Titan (RR = 5.5) stems had higher revision rates due to aseptic loosening than Charnley. The analyses also showed a marked improvement in Charnley results between the periods 1987–1997 and 1998–2007. Interpretation We observed clinically important differences between cemented prosthesis brands and identified inferior results for previously largely undocumented prostheses, including the commonly used prosthesis combination Reflection All-Poly/Spectron-EF. The results were, however, satisfactory according to international standards.