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1.  Shoulder instability surgery in Norway 
Acta Orthopaedica  2012;83(2):165-170.
Background and purpose
In January 2008, we established the Norwegian Register for Shoulder Instability Surgery. We report on the establishment, the baseline data, and the results at 1-year follow-up.
Primary and revision shoulder stabilization is reported by the surgeon on a 1-page paper form containing the patient's history of shoulder injury, clinical findings, and perioperative findings. The WOSI questionnaire for self-assessment of shoulder function is completed at baseline and at follow-up after 1, 2, and 5 years. To evaluate the completeness of registration, we compared our data with those in the Norwegian Patient Registry (NPR).
The NPR reported 39 hospitals performing shoulder stabilizations. 20 of these started to report to our register during 2009, and 464 procedures (404 primary, 59 revisions) were included up to December 31, 2009, which represented 54% of the procedures reported to NPR. Of the 404 primary procedures, 83% were operations due to anterior instability, 10% were operations due to posterior instability, and 7% were operations due to multidirectional instability. Arthroscopic soft tissue techniques were used in 88% of the patients treated for primary anterior instability and open coracoid transfer was used in 10% of such patients. At 1-year follow-up of 213 patients, we found a statistically significantly improved WOSI score in all types of instability. 10% of the patients treated with arthroscopic anterior labral repair and 16% treated with arthroscopic posterior labral repair reported recurrent instability. No statistically significant difference in functional improvement or rate of recurrence was found between these groups.
The functional results are in accordance with those in previous studies. However, the incidence of recurrent instability 1 year after arthroscopic labral repair is higher than expected.
PMCID: PMC3339531  PMID: 22112155
2.  Is there still a place for the cemented titanium femoral stem? 
Acta Orthopaedica  2012;83(1):1-6.
Background and purpose
Despite the fact that there have been some reports on poor performance, titanium femoral stems intended for cemented fixation are still used at some centers in Europe. In this population-based registry study, we examined the results of the most frequently used cemented titanium stem in Norway.
Patients and methods
11,876 cases implanted with the cemented Titan stem were identified for the period 1987–2008. Hybrid arthroplasties were excluded, leaving 10,108 cases for this study. Stem survival and the influence of age, sex, stem offset and size, and femoral head size were evaluated using Cox regression analyses. Questionnaires were sent to the hospitals to determine the surgical technique used.
Male sex, high stem offset, and small stem size were found to be risk factors for stem revision, (adjusted RR = 2.5 (1.9–3.4), 3.3 (2.3–4.8), and 2.2 (1.4–3.5), respectively). Patients operated in the period 2001–2008 had an adjusted relative risk (RR) of 4.7 (95% CI: 3.0–7.4) for stem revision due to aseptic stem loosening compared to the period 1996–2000. Changes in broaching technique and cementing technique coincided with deterioration of the results in some hospitals.
The increased use of small stem sizes and high-offset stems could only explain the deterioration of results to a certain degree since the year 2000. The influence of discrete changes in surgical technique over time could not be fully evaluated in this registry study. We suggest that this cemented titanium stem should be abandoned. The results of similar implants should be carefully evaluated.
PMCID: PMC3278649  PMID: 22206445
3.  Infection after primary hip arthroplasty 
Acta Orthopaedica  2011;82(6):646-654.
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.
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.
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.
PMCID: PMC3247879  PMID: 22066562
4.  A randomized study on migration of the Spectron EF and the Charnley flanged 40 cemented femoral components using radiostereometric analysis at 2 years 
Acta Orthopaedica  2011;82(5):538-544.
Background and purpose
We performed a randomized study to determine the migration patterns of the Spectron EF femoral stem and to compare them with those of the Charnley stem, which is regarded by many as the gold standard for comparison of implants due to its extensive documentation.
Patients and methods
150 patients with a mean age of 70 years were randomized, single-blinded, to receive either a cemented Charnley flanged 40 monoblock, stainless steel, vaquasheen surface femoral stem with a 22.2-mm head (n = 30) or a cemented Spectron EF modular, matte, straight, collared, cobalt-chrome femoral stem with a 28-mm femoral head and a roughened proximal third of the stem (n = 120). The patients were followed with repeated radiostereometric analysis for 2 years to assess migration.
At 2 years, stem retroversion was 2.3° and 0.7° (p < 0.001) and posterior translation was 0.44 mm and 0.17 mm (p = 0.002) for the Charnley group (n = 26) and the Spectron EF group (n = 74), respectively. Subsidence was 0.26 mm for the Charnley and 0.20 mm for the Spectron EF (p = 0.5).
The Spectron EF femoral stem was more stable than the Charnley flanged 40 stem in our study when evaluated at 2 years. In a report from the Norwegian arthroplasty register, the Spectron EF stem had a higher revision rate due to aseptic loosening beyond 5 years than the Charnley. Initial stability is not invariably related to good long-term results. Our results emphasize the importance of prospective long-term follow-up of prosthetic implants in clinical trials and national registries and a stepwise introduction of implants.
PMCID: PMC3242949  PMID: 21895504
5.  Statistical analysis of arthroplasty data 
Acta Orthopaedica  2011;82(3):253-257.
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, this one with an introduction and a discussion of the background to the guidelines, and the second one with a more technical statistical discussion on how specific problems can be handled (Ranstam et al. 2011b, see pages x-y in this issue). This first part contains an overview of implant survival analysis and statistical methods used to evaluate factors with a potential influence on this outcome.
PMCID: PMC3235301  PMID: 21619499
6.  Statistical analysis of arthroplasty data 
Acta Orthopaedica  2011;82(3):258-267.
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.
PMCID: PMC3235302  PMID: 21619500
7.  Failure of total knee arthroplasty with or without patella resurfacing 
Acta Orthopaedica  2011;82(3):282-292.
Background and purpose
Patella resurfacing during primary total knee arthroplasty (TKA) is disputed and new prosthesis designs have been introduced without documentation of their survival. We assessed the impact on prosthesis survival of patella resurfacing and of prosthesis brand, based on data from the Norwegian Arthroplasty Register.
Patients and methods
5 prosthesis brands in common use with and without patella resurfacing from 1994 through 2009 were included n = 11,887. The median follow-up times were 9 years for patella-resurfaced implants and 7 years for implants without patella resurfacing. For comparison of prosthesis brands, also brands in common use with only one of the two treatment options were included in the study population (n = 25,590). Cox regression analyses were performed with different reasons for revision as endpoints with adjustment for potential confounders.
We observed a reduced overall risk of revision for patella resurfaced (PR) TKAs, but the statistical significance was borderline (RR = 0.84, p = 0.05). At 15 years, 92% of PR and 91% of patella non resurfaced (NR) prostheses were still unrevised. However, PR implants had a lower risk of revision due to pain alone (RR = 0.1, p < 0.001), but a higher risk of revision due to loosening of the tibial component (RR = 1.4, p = 0.03) and due to a defective polyethylene insert (RR = 3.2, p < 0.001).
At 10 years, the survival for the reference NR brand AGC Universal was 93%. The NR brands Genesis I, Duracon, and Tricon (RR = 1.4–1.7) performed statistically significantly worse than NR AGC Universal, while the NR prostheses e.motion, Profix, and AGC Anatomic (RR = 0.1–0.7), and the PR prostheses NexGen and AGC Universal (RR = 0.4–0.5) performed statistically significantly better. LCS, NexGen, LCS Complete (all NR), and Tricon, Genesis I, LCS, and Kinemax (all PR) showed no differences in this respect from the reference brand. A lower risk of revision (crude) was found for TKAs performed after 2000 as compared to those performed earlier (RR = 0.8, p = 0.001).
Although revision risk was similar for PR and NR TKAs, we found important differences in reasons for revision. Our results also indicate that survivorship of TKAs has improved.
PMCID: PMC3235305  PMID: 21619502
8.  Short-term outcome of 1,465 computer-navigated primary total knee replacements 2005–2008 
Acta Orthopaedica  2011;82(3):293-300.
Background and purpose
Improvement of positioning and alignment by the use of computer-assisted surgery (CAS) might improve longevity and function in total knee replacements, but there is little evidence. In this study, we evaluated the short-term results of computer-navigated knee replacements based on data from the Norwegian Arthroplasty Register.
Patients and methods
Primary total knee replacements without patella resurfacing, reported to the Norwegian Arthroplasty Register during the years 2005–2008, were evaluated. The 5 most common implants and the 3 most common navigation systems were selected. Cemented, uncemented, and hybrid knees were included. With the risk of revision for any cause as the primary endpoint and intraoperative complications and operating time as secondary outcomes, 1,465 computer-navigated knee replacements (CAS) and 8,214 conventionally operated knee replacements (CON) were compared. Kaplan-Meier survival analysis and Cox regression analysis with adjustment for age, sex, prosthesis brand, fixation method, previous knee surgery, preoperative diagnosis, and ASA category were used.
Kaplan-Meier estimated survival at 2 years was 98% (95% CI: 97.5–98.3) in the CON group and 96% (95% CI: 95.0–97.8) in the CAS group. The adjusted Cox regression analysis showed a higher risk of revision in the CAS group (RR = 1.7, 95% CI: 1.1–2.5; p = 0.02). The LCS Complete knee had a higher risk of revision with CAS than with CON (RR = 2.1, 95% CI: 1.3–3.4; p = 0.004)). The differences were not statistically significant for the other prosthesis brands. Mean operating time was 15 min longer in the CAS group.
With the introduction of computer-navigated knee replacement surgery in Norway, the short-term risk of revision has increased for computer-navigated replacement with the LCS Complete. The mechanisms of failure of these implantations should be explored in greater depth, and in this study we have not been able to draw conclusions regarding causation.
PMCID: PMC3235306  PMID: 21504309
9.  Does patella resurfacing really matter? Pain and function in 972 patients after primary total knee arthroplasty 
Acta Orthopaedica  2010;81(1):99-107.
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.
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.
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.
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.
PMCID: PMC2856212  PMID: 20158405
10.  Increasing risk of revision due to deep infection after hip arthroplasty 
Acta Orthopaedica  2009;80(6):639-645.
Background and purpose Over the decades, improvements in surgery and perioperative routines have reduced the incidence of deep infections after total hip arthroplasty (THA). There is, however, some evidence to suggest that the incidence of infection is increasing again. We assessed the risk of revision due to deep infection for primary THAs reported to the Norwegian Arthroplasty Register (NAR) over the period 1987–2007.
Method We included all primary cemented and uncemented THAs reported to the NAR from September 15, 1987 to January 1, 2008 and performed adjusted Cox regression analyses with the first revision due to deep infection as endpoint. Changes in revision rate as a function of the year of operation were investigated.
Results Of the 97,344 primary THAs that met the inclusion criteria, 614 THAs had been revised due to deep infection (5-year survival 99.46%). Risk of revision due to deep infection increased throughout the period studied. Compared to the THAs implanted in 1987–1992, the risk of revision due to infection was 1.3 times higher (95%CI: 1.0–1.7) for those implanted in 1993–1997, 1.5 times (95% CI: 1.2–2.0) for those implanted in 1998–2002, and 3.0 times (95% CI: 2.2–4.0) for those implanted in 2003–2007. The most pronounced increase in risk of being revised due to deep infection was for the subgroup of uncemented THAs from 2003–2007, which had an increase of 5 times (95% CI: 2.6–11) compared to uncemented THAs from 1987–1992.
Interpretation The incidence of deep infection after THA increased during the period 1987–2007. Concomitant changes in confounding factors, however, complicate the interpretation of the results.
PMCID: PMC2823304  PMID: 19995313
11.  18 years of results with cemented primary hip prostheses in the Norwegian Arthroplasty Register 
Acta Orthopaedica  2009;80(4):402-412.
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.
PMCID: PMC2823190  PMID: 19857178

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