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Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 447 - 447
1 Sep 2009
Thien T Malchau H Herberts P Kärrholm J
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In a previous report from a randomised study we reported excellent fixation and less proximal periprosthetic bone mineral loss around the Epoch design at 2 years follow-up when compared with a solid stem of similar design. We now present the 7 years follow-up.

Forty consecutive patients (20 men, 10 women, mean age 57, 41–74) with non-inflammatory osteoarthritis were randomised to receive either a cementless porous-coated composite stem with reduced stiffness (Epoch) or a cementless stiff stem with a porous coating (Anatomic). Patients were followed for 7 years with repeated evaluations using radiostereometry, DXA, conventional radiography and Harris Hip Score (HHS).

At 7 years 1 stem had been revised (Anatomic) due to late infection. Subsidence and stem rotations were close to zero without any difference between the two groups (p> 0,12). Median wear rates were lower than expected (0.4mm up to 7 years) for both stem designs. At 2 years loss bone mineral density was less in Gruen regions 1, 2, 6 and 7 for the Epoch stems (p< 0.04), but this difference tended to disappear with time. At 7 years only the calcar region (Gruen region 7) had significantly denser bone in the Epoch group (p< 0.001). The HHS scores did not differ (median 98, 51–100). No stem was radiographically loose.

The Epoch stem achieved excellent fixation. Wear rates were low despite use of conventionally gamma-sterilised polyethylene. This low modulus stem had positive effects on early proximal bone remodeling, but this effect decreased with time.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 35 - 35
1 Mar 2009
Kurtz S Lau E Havelin L Dybvik E Ong K Malchau H
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Starting in the 1970s, long-term survivorship of total hip and knee arthroplasty has been under investigation for the Scandinavian population with the aid of implants registries. In the United States, no national arthroplasty registry currently exists. Nationwide inpatient discharge databases in the United States have proven useful when comparing the revision burden in the United States and Scandinavia. For this study, we compared the implant survivorship in the Medicare population with contemporaneous registry-based data from well-established and validated Scandinavian arthroplasty registries. The 5% systematic sample of Medicare claims from 1997 to 2004 were examined for primary and revision THA and TKA claims. The Medicare beneficiary ID was used to follow patients longitudinally between primary and revision surgery. De-identified data from the Norwegian and Swedish national hip and knee registry were also obtained for the same time period. During the 8-year study period, 30,583 and 62,878 elective primary total hip or knee replacements, respectively, were extracted from the Medicare data. In the same time period, 41,823 and 15,927 primary total hips or knees replacements were identified from the Norwegian registry. 82,037 primary total hips were identified from the Swedish registry. Survivorship was assessed by the Kaplan-Meier method, and Cox regression was used to evaluate the effect of patient attributes and cross-country comparisons. The K-M estimate showed that 8 years post-primary surgery, 93.6% of THA and 96.2% of TKA remained revision-free among the elderly Medicare population. By comparison, among Norwegians aged 65 and above, 96.0% of THA and 93.6% of TKA remained revision-free. In the US, men had a significantly higher risk of knee revision than women, but no significant gender difference among hip revision. In Norway, men had a significantly higher risk of hip revision, but no differences in knee revisions. In Sweden, men had a significantly higher risk of hip revision (5.4% vs. 3.3%). Older patients had a reduced risk of revision as compared with younger patients, in both the US and in Norway. The survival of THA is significantly better in Norway than in the US with a hazard ratio of 1.64 (p< 0.05). On the other hand, TKA had a better survival experience in the US than in Norway, with a hazard ratio of 0.55 (p< 0.05). This is the first study to evaluate the utility of Medicare as a source of THA and TKA survivorship data and to compare prosthesis outcomes in Medicare with those from Scandinavian arthroplasty registries. Unlike the Norwegian and Swedish registry data, the reasons for revision (e.g., femoral loosening) are not captured and thus greatly limited the value of the Medicare data as a tool to understand the need for revision, thereby helping to improve implant longevity and to reduce the associated cost and burden to the patient and care provider.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 106 - 106
1 Mar 2009
Lindahl H Malchau H Garellick G Herberts P
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INTRODUCTION: The postoperative periprosthetic femoral fracture is a severe complication after total hip surgery. It has become the third most common reason for revision. Three-hundred and twenty one fractures operated during 1999–2000, were followed in a prospective nationwide study. The study focused on the failure rate, patient satisfaction, treatment and radiographic evaluation.

PATIENTS AND METHODS: During 1999–2000, 230 fractures after a primary THR and 91 after a revision THR were reported to the Swedish National Hip Arthroplasty Register. All hospital records were collected. At follow-up the Harris hip score, a health-related quality of life measure (EQ-5D) and patient satisfaction were used as outcome measurement. A radiologist performed the radiographic evaluation.

RESULTS: A high number of patients had a loose implant at fracture time (66% in the primary group and 51% in the revision group). Eighty-eight percent of the fractures were classified as Vancouver type B fractures. A major finding was the association between the type of implant and the risk of a periprosthetic fracture. The Charnley and the Exeter prostheses were significantly over represented among patients with fractures and the Lubinus prosthesis significantly under represented. The surgeons grading of the Vancouver type B1 fracture was not in agreement with the study radiologist in more than 34% of the cases. Patient’s satisfaction concerning mobility, self-care, normal activities, pain and anxiety compared to an age matched population with a THR were poor. There was a high failure rate and by December 31, 2004, 22% had been reoperated.

DISCUSSION: A recommendation is to follow all THR patients with regularly radiographic monitoring and to intervene before the fracture. Implant related factors have to be considered when choosing implant for routine use. Difficulty in evaluating the x-rays concerning the stability of the prostheses might lead to sub optimal treatment. We recommend exploration of the implant for all patients with a Vancouver type B fracture if there is any doubt about the fixation status.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 2 | Pages 157 - 161
1 Feb 2009
Rolfson O Dahlberg LE Nilsson J Malchau H Garellick G

In this study we hypothesised that anxiety/depression, one of five dimensions in the health-related quality of life (HRQoL) measurement tool EQ-5D, could predict outcome after total hip replacement surgery.

Pre-operative and one-year post-operative data from the Swedish Hip Arthroplasty Register, including 6158 patients with primary osteoarthritis of the hip, were analysed. In order to examine the association between anxiety and outcome with respect to pain and satisfaction an analysis of covariance was used.

The pre-operative EQ-5D anxiety/depression dimension was a strong predictor for pain relief and patient satisfaction (p < 0.001).

Orthopaedic surgeons involved in the care of patients eligible for total hip replacement surgery should be aware that mental health may influence post-operative pain and HRQoL. An appropriate assessment of mental health may enable a modification in the way these patients are managed in order to optimise the outcome after joint replacement surgery.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 45 - 45
1 Mar 2006
Digas G Kärrholm J Thanner J Malchau H Herberts P
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Introduction: The annual wear rate in polyethylene articulations should be 0.1 mm or less to avoid future osteolysis. Highly Crosslinked polyethylene demonstrates 80–90% wear reduction in hip simulator testing, but the clinical documentation of this new polyethylene is still inadequate. We evaluated the highly crosslink PE in two prospective randomised clinical studies. Patients and Methods: Thirty two patients (12 male, 20 female, 64 hips) with a median age of 48 years (range, 29–70 years) with bilateral primary or secondary arthrosis of the hip received hybrid THA. With liners made of highly cross-link on one side and conventional PE on the other one. Twenty-seven patients in this study have passed 2 years follow up. Further Sixty patients (61 hips) with a median age of 55 years (range, 35–70 years) were randomized to receive either highly crosslink or conventional cemented all PE of the same design. Forty-nine patients have been followed for 3 years. In both studies all patients received Spectron stems with 28mm cobalt-chromium head. Radiostereometric examinations with the patient supine or standing were done at regular intervals. Wear was measured in the supine position from the postoperative week, whereas standing examinations were initiated three months after the operation. Results: The penetration rate was almost identical in the study and control groups in 6 months after the operation. Thereafter the penetration rate levelled out in the 2 groups with highly crosslink PE. At two years the highly crosslink PE liner showed 62% lower proximal penetration and 31% lower total (three-dimensional) penetration when the patients were examined in supine position. The highly crosslink all PE cemented cups showed significantly lower proximal penetration in both position. Discussion: The better wear performance of highly crosslink PE could increase the implant longevity. Longer follow up is needed to evaluate if this new material is associated with less occurrence of osteolysis.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 47 - 48
1 Mar 2006
Hilmarsson S Soderman P Herbert P Malchau H
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Objectives. The Swedish National Total Hip Arthroplasty Register, initiated in 1979, describes the epidemiology of total hip replacement (THR) in Sweden. The objective of this study was to describe the epidemiology, demographics and to perform an outcome analysis on patients, younger than 55 years, who underwent a total hip replacement in Sweden between 1992–2002. Methods. From the Swedish National Total Hip Arthroplasty Register 11579 patients, younger than 55 years at the time of surgery, were identified who had undergone a primary total hip replacement from 1992–2002. The patients selected were checked with the Swedish Cause of Death Register (CDR), based on the unique identification number used in Sweden, to ensure that only living patients were addressed. Epidemiological and demographical analysis was then performed using SPSS (SPSS Inc, Chicago, IL). Outcome. 11362 patients were identified. 5260 (46,3 %) men and 6102 (53,7 %) women, the mean age was 48, 2 years (14–55). The indication for surgery was in over 60% of the cases Osteoarthrosis (OA) but over-represented diagnosis, when compared to the remaining THR operations in Sweden, were arthritis, osteonecrosis and sequele after childhood disease. The most common fixation technique used was cemented total hip replacement in 6160 (54,2 %) followed by Hybrid 2442 (21,5 %) and uncemented 2235 (19,7 %) technique. Survival for cemented, uncemented and hybrid implants in male patients with Osteoarthrosis after 10 years was 65,8 % (+/− 2,6%), 66,6 % (+/− 2,9%) and 64,0 % (+/− 3,0 %) respectively. In the arthritis group the survival was slightly better with a 10 year survival of 72,8 % (+/− 3,6%), 66,8 % (+/− 5,9%) and 71,5 % (+/− 7,5%) respectively, male patients had a slightly inferior outcome compared to females across all diagnosis groups. Conclusions. This young cohort is epidemiologically and demographically different than the older one previously studied in the Swedish National Hip Register. Survival analysis shows that 10 year survival in this population is considerably worse than for the older cohort. Patients with arthritis fare better than patients with Osteoarthrosis and females have superior outcome to males. In this study the mode of implant fixation did not appear to influence survival in patients with OA, however it does seem to affect the outcome in patients with inflammatory arthritis. This study shows that the outcome in this patient category is poor when compared with the older THR patients. There is an obvious need to increase use of alternative and conservative methods in treatment of the young patient with degenerative hip disease. Continuous research and referral of the young patients to dedicated centres is recommended.


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 1 | Pages 26 - 30
1 Jan 2006
Lindahl H Malchau H Odén A Garellick G

Periprosthetic fracture of the femur is an uncommon complication after total hip replacement, but appears to be increasing. We undertook a nationwide observational study to determine the risk factors for failure after treatment of these fractures, examining patient- and implant-related factors, the classification of the fractures and the outcome.

Between 1979 and 2000, 1049 periprosthetic fractures of the femur were reported to the Swedish National Hip Arthroplasty Register. Of these, 245 had a further operation after failure of their initial management. Data were collected from the Register and hospital records. The material was analysed by the use of Poisson regression models.

It was found that the risk of failure of treatment was reduced for Vancouver type B2 injuries (p = 0.0053) if revision of the implant was undertaken (p = 0.0033) or revision and open reduction and internal fixation (p = 0.0039) were performed. Fractures classified as Vancouver type B1 had a significantly higher risk of failure (p = 0.0001). The strongest negative factor was the use of a single plate for fixation (p = 0.001). The most common reasons for failure in this group were loosening of the femoral prosthesis, nonunion and re-fracture.

It is probable that many fractures classified as Vancouver type B1 (n = 304), were in reality type B2 fractures with a loose stem which were not recognised. Plate fixation was inadequate in these cases. The difficulty in separating type B1 from type B2 fractures suggests that the prosthesis should be considered as loose until proven otherwise.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 242 - 242
1 Mar 2004
Digas G Kärrholm J Thanner J Malchau H Herberts P
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Aims: The aim of this study was to evaluate a highly cross-linked polyethylene WIAM in cemented hip arthroplasty. This new polyethylene has been resistant to wear in laboratory tests. Methods: 60 patients (30 women, 30 men) with a median age of 55 years (35–70) and a median weight 82 kg (47–120) were included. All patients received a Spectron femoral stem with a 28 mm head in chrome-cobalt. The patients were randomised to acetabular cups made of either WIAM (electron beam irradiation 9.5 Mrad) or conventional polyethylene (CP) sterilized in inert atmosphere. Radiostereometric examinations (supine) were done 7 days after the operation and after 3, 6 12 and 24 months. Examinations (standing) were performed at 3, 6 12 and 24 months. The migration of the femoral head centre in relation to the polyethylene marker represented the femoral head penetration. Results:. 43 hip (19 WIAM 24 CP) were available for 24 months FU. There were no differences in cup migrations between the two groups. The mean proximal penetration (supine and standing) was less than 0.2 mm at 24 months in both groups p> 0,06 Conclusions: The femoral head penetration during the first two years may be dominated by creep. There is tendency for lower proximal penetration at standing examination in the WIAM group. Futher studies and longer follow up is necessary until highly crosslink polyethylene can be recommended for general use.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 217 - 217
1 Mar 2004
Herberts P Malchau H
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Aims: In 1979 a national observation study of total hip arthroplasties was started in Sweden. The Swedish Hip Register describes the epidemiology of primary and revision surgery and identifies risk factors for failure. Every unit reports details concerning implants, surgical and cementing technique and revision procedures online via the Internet home page (www.jru.orthop.gu.se). Methods: Currently the register contains 203 625 primary total hip arthroplasties performed during 1979–2001 and 18 067 revision procedures. Revision is the failure endpoint definition and modified Kaplan-Meier statistics and Poisson models are used for survival analysis. Each hospital receive their results annually providing a system for continuous improvement. Results: The results show that serious complications have declined significantly despite an increasing number of patients at risk. The revision burden for cemented THR (94% of the implants are cemented) is only 7.5%, which is much lower than in other countries. Over the 22 year period revision for aseptic loosening has been reduced to one quarter. Demographics are important since male gender and young age significantly increase the risk for revision. Cementless implants have in general had a worse outcome than expected but improved during the last decade. Conclusion: Problem areas are the young population and revision surgery which must be improved. The revision burden is about two times higher in all other countries. This finding implies that the register is extremely cost-effective and the reduction in direct costs for the health care service in Sweden corresponds to approximately USD 140 millions over the last ten years.


Orthopaedic Proceedings
Vol. 85-B, Issue SUPP_III | Pages 202 - 202
1 Mar 2003
Devane P Horne J Hauser-Kara D Martell J Malchau H Harris W
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The purpose of this study was to compare the 2D and 3D linear and volume wear readings of the three most commonly used methods for measuring polyethylene wear: the Livermore, Devane and Martell techniques. Inter-observer variation of measurements using the techniques of Devane and of Martell on conventional radiographs was also performed. The radiographs of 80 patients (mean age 60+/−10 yrs) who had a Harris-Galante I total hip arthroplasty were measured. Nine different reviewers for the Devane technique readings including Dr Devane and eight reviewers for the Martell technique readings including Dr Martell made blinded independent wear observations for each radiograph set. One reviewer measured the 20 annual linear wear rate for all radiograph sets using the 2D Livermore technique. Inter-observer variation as a function of patient, reviewer, and total variation was statistically assessed using variance component analysis. Mean wear measured using the Livermore technique was the same as with the Devane and Martell method, but with a greater variation. Comparison of the Devane and Martell method for patient STD, reviewer STD, error STD (multiple reviews of same radiographs), total STD (randomly picked reviewer), mostly show a mean 50% lower STD with the Devane technique. Correlation (correlation coefficient of two randomly selected reviewers) is significantly better with the Devane technique.


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_III | Pages 255 - 255
1 Nov 2002
Malchau H Kärrholm J Thanner J Herberts P
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Introduction: In a pioneer study Oonishi et al (1988) found reduced socket wear with the use of polyethylene subjected to high radiation doses. This observation has stimulated the development of a new generation polyethylene. In addition to high radiation doses the plastic is also subjected to various types of heat treatment to reduce the amount of free radicals. The purpose of the present study is to evaluate one of the new highly cross-linked polyethylenes in a randomized controlled study of cemented THA. The hypothesis is that the improved wear resistance will reduce the prevalence of osteolytic lesions with long-term follow-up.

Methods and materials: Patients in clinical and radiographic need of a THR with non-inflammatory osteoarthritis of the hip were randomized in two groups. Group 1 received a cemented Weber cup (Sulzer®, Switzerland) made of highly cross-linked (WIAM) polyethylene, group 2 got a conventional cup. All patients received a cemented Spectron (Smith & Nephew, USA) with a 28mm cobalt-chromium head.

So far 15 patients, (6 male and 9 females) with a median age of 55 years (range 42–62) have been evaluated in group 1 and 14 (9 male and 5 females) with a median age of 55 years (range 45–70) in group 2. The penetration of the femoral heads has so far been measured postoperatively (all hips supine), after 3 month (17 hips supine and standing) and after 6 month (11 hips supine and standing) using radiostereometry.

Results: The median proximal and three-dimensional (3-D) penetration (total wear) 0–6 month (supine position) was almost equal in the two groups. Group 1 had a proximal penetration of 0.08 mm (range 0.00–0.17) and a total penetration of 0.11 mm (range 0.06–0.14). The corresponding values for group 2 were 0,10 mm (0.05–0.21) for proximal penetration and 0.13 mm (0.10–0.16) for total penetration. Between 3 and 6 month the penetration (median values) was 0.04 mm/0.10 mm (proximal/3-D) for group 1 and 0.07 mm/0.12 mm for group 2. With the patients standing we found a proximally migration of the socket (0–6 month) in group 1 of 0,08 mm (−0.07 – 0.21) and 0.12 mm (0.1–0.13) in group 2.

Discussion: Use of a highly cross-linked polyethylene in the socket did not influence the early penetration rate after THR. Early creep of the material is possible explanation.

1-year follow-up on approximately 50% of the patients will be presented at the meeting.


The Journal of Bone & Joint Surgery British Volume
Vol. 81-B, Issue 1 | Pages 135 - 142
1 Jan 1999
Kärrholm J Hultmark P Carlsson L Malchau H

We revised 24 consecutive hips with loosening of the femoral stem using impaction allograft and a cemented stem with an unpolished proximal surface. Repeated radiostereometric examinations for up to two years showed a slow rate of subsidence with a mean of 0.32 mm (−2.0 to +0.31). Fifteen cases followed for a further year showed the same mean subsidence after three years, indicating stabilisation. A tendency to retroversion of the stems was noted between the operation and the last follow-up. Retroversion was also recorded when displacement of the stem was studied in ten of the patients after two years. Repeated determination of bone mineral density showed an initial loss after six months, followed by recovery to the postoperative level at two years. Defects in the cement mantle and malalignment of the stem were often noted on postoperative radiographs, but did not correlate with the degrees of migration or displacement. After one year, increasing frequency of trabecular remodelling or resorption of the graft was observed in the greater trochanter and distal to the tip of the stem. Cortical repair was noted distally and medially (Gruen regions 3, 5 and 6). Migration of the stems was the lowest reported to date, which we attribute to the improved grafting technique and to the hardness of the graft.


The Journal of Bone & Joint Surgery British Volume
Vol. 80-B, Issue 4 | Pages 600 - 606
1 Jul 1998
Garellick G Malchau H Herberts P

We assessed 100 patients with a primary total hip replacement using the Harris hip score and the Nottingham Health Profile at one, three and five years after operation. They were derived from two prospective randomised series of cemented and uncemented replacements.

Both scoring systems correlated highly and were each heavily influenced by the system of functional classification defined by Charnley. After five years both reflected the function of the implant and the general state of the patient. A higher degree of sensitivity is needed to show differences in the performance of an implant in the short and medium term. We do not yet have an ideal system of clinical assessment and the overall function must always be properly assessed.


The Journal of Bone & Joint Surgery British Volume
Vol. 78-B, Issue 6 | Pages 884 - 891
1 Nov 1996
Malchau H Herberts P Wang YX Kärrholm J Romanus B

We enrolled 98 patients (107 hips) with a mean age of 47 years (SD 8.6) into a prospective study of the Madreporic Lord THR; 34 hips had primary and 73 secondary osteoarthritis.

After ten years, the survival rate using revision as the endpoint for failure was 70% (±9) for the cup and 98% (±0.3) for the stem. The combined clinical and radiological survival rates were 46% (±11) and 81% (±10), respectively. Osteoporosis due to stress-shielding was observed in the proximal femur. Hips with radiologically dense bone postoperatively showed the most pronounced bone loss.

We recommend continued radiological follow-up of patients with this type of implant to allow revision to be performed before there is severe bony destruction of the pelvis.