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Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 280 - 281
1 May 2009
Slätis P Malmivaara A Heliövaara M Sainio P Seitsalo S Hurri H Tallroth K
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The aim of the study was to assess the effectiveness of surgical treatment for degenerative lumbar spinal stenosis (LSS) as compared with non-operative measures. Four university hospitals contributed, after agreement on study protocol, surgical rationale and non-operative procedures (For details, see Spine2007;32:1–8). Ninety-four patients were randomized into a surgical or nonoperative treatment group, 50 and 44 patients, respectively. Surgery comprised undercutting laminectomy of the stenotic segments, in 10 patients augmented with transpedicular instrumented fusion. The primary outcome was based on assessment of functional disability using the Oswestry Disability Index (ODI, scale 0–100). Intensity of leg and back pain (scales 0–10), as well as self-reported walking ability, were recorded at randomization and at follow-ups at 6, 12, 24 months and on average 6 years after the randomization. At the 2-year follow-up, back and leg pain scales and ODI had improved more in the surgical than the nonoperative group (p-values for global difference < 0,01). At the 6-year follow-up the mean difference in ODI in favor of surgery was 9.5 (95% confidence interval 0.9–18.1). However, the intensity of pains did not any-more differ between the two treatment groups at the 6-year follow-up. Walking ability did not differ between the treatment groups at any time point. Of the 44 patients in the nonoperative group, 4 had been subjected to surgery within two years after randomization because of persistent symptoms.

We conclude that surgical treatment improves functional ability in lumbar spinal stenosis. We emphasize that improvement also occurs after nonoperative measures. We recommend starting treatment with non-operative measures during a 2-year surveillance period, as during this period only 10 per cent of the patients will need surgical intervention.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 341 - 342
1 Mar 2004
Karppinen J Korhonen T Malmivaara A Paimela L Seitsalo S Hurri H
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Aims: To evaluate the efþcacy and safety of inßiximab, a monoclonal chimeric antibody against TNFα, for the treatment of severe sciatica. Background: Evidence from animal studies indicates that tumour necrosis factor (TNF)α plays a role in the pathophysiology of sciatica. Anti-TNFα therapy has not been previously evaluated in sciatic patients. Methods: 10 patients with disc herniation-induced severe sciatica received inßiximab (Remi-cade¨; 3mg/weight-kg) intravenously over 2 hours. The outcome was assessed at 1 hour, 1 week, 2 weeks, 1 month and 3 months after the infusion, and was compared to historical controls consisting of 62 patients who received saline in a trial of periradicular inþltration for sciatica. Leg pain was the primary outcome, with over 75% decrease from baseline score constituting a painless state. Fisherñs exact test and repeated measures analysis of variance were used for statistical analysis. Results: One hour after the infusion, leg pain had decreased by 50%. At 2 weeks, 60% of patients in the inßiximab group were painless vs. 16% of control patients (P = 0.006). The difference was sustained at 3-months (90% vs. 46%; P = 0.014). Inßiximab was superior over the whole follow-up period in leg pain (P=0.003) and back-related disability (P=0.004). At 1 month, every patient in the inßiximab group had returned to work whereas 38% of controls were still on sick leave (P=0.02). None of the patients treated with inßiximab underwent surgery during the follow-up. No immediate or delayed adverse drug reactions, or any adverse effects due to medication were observed. Conclusions: Anti-TNFα therapy is a promising treatment option for sciatica. There is an urgent need for a ran-domised controlled trial to evaluate if these promising early results can be conþrmed.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 305 - 305
1 Mar 2004
Torkki M Malmivaara A Seitsalo S Hoikka V Laippala P Paavolainen P
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Aims: Hallux valgus operations cannot always be carried out immediately due to long waiting lists. Effect of waiting for hallux valgus surgery has not been under investigation in a randomized controlled study. Methods: 209 consecutive patients (mean age 48 years, 93% female) with a painful hallux valgus were randomized in three groups: immediate operation or one year waiting time with or without foot orthoses. The follow-up period was 2 years. Main outcome measure was pain intensity during walking (VAS 0 to 100). Results: During the þrst year 64/71, 0/69 and 4/69 patients were operated in surgery, orthosis and no-orthosis groups, respectively, and during the two-year follow-up 66, 43 and 48, respectively. At one-year follow-up the pain was least intensive in surgery group. At two year follow-up the pain intensity was similar in all groups. The satisfaction with treatment was the best in the surgery group and orthosis group as was the fact also with the cosmetic disturbances. The total costs of care were similar in all groups. Conclusion: Immediate operation is superior to delayed operation or foot orthoses, as the beneþt from surgery is obtained already during the þrst follow-up year. If this, however, because of limited operative capacity is not possible, one year waiting, with or without orthois, does not jeopardize the results.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 378 - 378
1 Mar 2004
Jari S Seitsalo S Paavolainen P
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Aim: The purpose of this report was to analyse the clinical and survivorship results and revision rates of Bichat III uncemented total hip arthroplasty in a community hospital setting. Poor results are rarely published what may have effect on the results of meta-analyses done on hip replacement surgery. At the time of selecting the prosthesis there were no reports published on this particular model. Methods: Between 1987 and 1990 þftyþve patients (57 hips) were operated using the Bichat III endoprosthesis. The prosthesis has a ßuted, anatomic and non-porous Ti femur, and a threaded nonporous acetabular cup. There were 25 male and 30 female patients. Mean age of the male patients was 62 (40–75) and that for the female 61 years (43–82). The indication for operation was primary arthrosis in 45, posttraumatic arthrosis in 5, LPC in 2 cases, and rheumatoid arthritis, AVN and CHD one each. All the operations were made using the Hardingen approach. For the survivorship analysis the patients were traced from the Finnish Arthroplasty Register and Kaplan-Meir survival was calculated for all the 57 patients with the 95% Cl. Those not revised until 31st December 2001 were called for clinical and radiological examination. The mean follow-up time was 12,7 years (11,4–14,2). Results: During the follow-up 16 patients died (28%), and revision was done on 21 patients (37%) after a mean follow-up time of 7,2 years (3,6–11,3). Seventeen patients arrived to the clinical follow-up; of those only 10 cases were without any radiological signs of loosening. For all the patients re-examined the Mayo Clinics Hip Score was 50.8 in average ((5–75), and that for those with radiological signs of loosening 46,3 (16–71). The survivorship calculated at ten years was 57,0% (95%Cl 42,5–71,6; 22 hips at risk). Typical features at revision were total loosening of both components, marked metallosis and breakage of the polyethylene liner. Conclusions: Our results are in accordance with other reports with uncemented, non-porous coated components, as well as with those of the screw þxed acetabular cups. Also the reports from other Nordic arthroplasty registers speak favour of the non-acceptable results with such concepts of THA. Publication of also the negative results of THA may decrease risk of sc. publication bias. We conclude that until now there is sufþcient evidence that porous coating on both components of hip endoprosthesis is crucial for reliable þxation of uncemented components. Prosthesis selection should be made on a well documented basis and trials should be made in arthroplasty centers and on a prospective and randomized basis.


Orthopaedic Proceedings
Vol. 85-B, Issue SUPP_III | Pages 241 - 241
1 Mar 2003
Karppinen J Korhonen T Malmivaara A Paimela L Seitsalo S Lindgren K Rantanen P Hurri H
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Introduction: Infliximab, a monoclonal antibody against tumour necrosis factor alfa (TNFα) has been used succesfully in the treatment of rheumatoid arthritis and Crohn’s disease. Recent animal studies suggest that TNFα also has an important role in the pathogenesis of sciatica. The purpose of this study was to evaluate the efficacy and safety of infliximab in the treatment of sciatic patients.

Methods: 10 patients with acute or subacute severe sciatica (duration of symptoms from 2 to 12 weeks) were included. A disc herniation corresponding to symptoms was confirmed by MRI in each case. Patients with previous back operation or with contraindications for infliximab were excluded. A dose of 3 mg/kg body weight of infliximab in saline was infused intravenously over 2 hours. Leg pain (100-mm Visual Analog Scale) was recorded before and one hour after the infusion, and later at 1 week, 2 weeks, 1 month, 3 months and 6 months. Changes in leg pain were compared statistically with 62 historical controls (saline group in a study of periradicular infiltration) using repeated measures analysis of variance. Changes in back pain, back-related disability on Oswestry Index and clinical status were also assessed.

Results: Mean (SD) leg pain before the infusion was 80 (18) mm in the infliximab group. One hour after the infusion, there was a decrease of 49% in leg pain. At 1 week mean leg pain was 26 (21), at 2 weeks 19 (20), at 1 month 18 (19), at 3 months 10 (16) and at 6 months 13 (8). When compared with the historical controls, the difference was in favour of infliximab for leg pain (19 mm; 95% CI, 6 to 32, P=0.005) and for back-related disability on Oswestry (12%; 95%CI, 4 to 20, P=0.003) over the 6 month follow-up period. At the one-month follow-up every patient in the infliximab group had returned to work compared to 38% of control patients (P=0.02). None of the patients treated with infliximab underwent surgery during the follow-up compared to 14 (23%) in the control group (P=0.09). No immediate or delayed adverse drug reactions were observed.

Conclusions: According to this study, a single infusion of infliximab seems to provide immediate, highly effective and safe treatment of sciatica through 6 months. Rapid return to work appears to be fascilitated, and surgery may possibly be avoided in some patients. There is an urgent need for a randomized trial to verify these results.