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Intra-articular hyaluronan injections in the treatment of osteoarthritis of the knee : A randomised, double blind, placebo controlled multicentre trial

Lohmander, L. Stefan LU ; Dalén, Nils; Englund, Gunnar; Hämäläinen, Martti; Jensen, Erik Martin; Karlsson, Kerstin; Odensten, Magnus; Ryd, Leif LU ; Sernbo, Ingemar LU and Suomalainen, Olavi, et al. (1996) In Annals of the Rheumatic Diseases 55(7). p.424-431
Abstract

Objective - To assess the effects of intraarticular injections of hyaluronan on symptoms of knee osteoarthritis (OA). Methods - Two hundred and forty patients with symptomatic, radiological knee OA were randomly assigned to treatment with weekly injections for five weeks with either 25 mg of high molecular weight hyaluronan or vehicle. Results were evaluated at weeks 1, 2, 3, 4, 5, 13, and 20 by visual analogue scales (pain, function, motion, activity), algofunctional index, and global evaluation by patient and investigator. Analysis was by 'intention to treat', 'per protocol), and area under the curve principles on unstratified patient groups and for patients stratified into four groups of equal size by age and baseline algofunctional... (More)

Objective - To assess the effects of intraarticular injections of hyaluronan on symptoms of knee osteoarthritis (OA). Methods - Two hundred and forty patients with symptomatic, radiological knee OA were randomly assigned to treatment with weekly injections for five weeks with either 25 mg of high molecular weight hyaluronan or vehicle. Results were evaluated at weeks 1, 2, 3, 4, 5, 13, and 20 by visual analogue scales (pain, function, motion, activity), algofunctional index, and global evaluation by patient and investigator. Analysis was by 'intention to treat', 'per protocol), and area under the curve principles on unstratified patient groups and for patients stratified into four groups of equal size by age and baseline algofunctional index. Results - No serious side effects were reported. At 20 weeks both treatment groups were improved compared with baseline, with no difference between unstratified groups treated with placebo or hyaluronan. Comparison of treatment-groups stratified by age and baseline algofunctional index revealed a significant-difference in favour of hyaluronan over placebo (pain, activity, algofunctional index, global evaluations by patient-and investigator) for patients older than 60 years and with a baseline algofunctional index greater than 10. There was no clinically relevant difference between the two treatments for the other three stratified subgroups of younger age or fewer symptoms. Similar results were obtained by area under the curve, intention to treat, and per protocol analysis. Conclusions-Patients older than 60 years with knee osteoarthritis and with significant symptoms corresponding to an index of severity of knee disease of 10 or more, comprise the group most likely to benefit from treatment with intra-articular hyaluronan injections.

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Annals of the Rheumatic Diseases
volume
55
issue
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8 pages
publisher
British Medical Association
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  • Scopus:8944220711
ISSN
0003-4967
language
English
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yes
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6c115c6e-6a23-4db1-ace6-0c1b8fd5ad6c
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2016-05-04 23:51:11
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2016-12-04 04:51:15
@misc{6c115c6e-6a23-4db1-ace6-0c1b8fd5ad6c,
  abstract     = {<p>Objective - To assess the effects of intraarticular injections of hyaluronan on symptoms of knee osteoarthritis (OA). Methods - Two hundred and forty patients with symptomatic, radiological knee OA were randomly assigned to treatment with weekly injections for five weeks with either 25 mg of high molecular weight hyaluronan or vehicle. Results were evaluated at weeks 1, 2, 3, 4, 5, 13, and 20 by visual analogue scales (pain, function, motion, activity), algofunctional index, and global evaluation by patient and investigator. Analysis was by 'intention to treat', 'per protocol), and area under the curve principles on unstratified patient groups and for patients stratified into four groups of equal size by age and baseline algofunctional index. Results - No serious side effects were reported. At 20 weeks both treatment groups were improved compared with baseline, with no difference between unstratified groups treated with placebo or hyaluronan. Comparison of treatment-groups stratified by age and baseline algofunctional index revealed a significant-difference in favour of hyaluronan over placebo (pain, activity, algofunctional index, global evaluations by patient-and investigator) for patients older than 60 years and with a baseline algofunctional index greater than 10. There was no clinically relevant difference between the two treatments for the other three stratified subgroups of younger age or fewer symptoms. Similar results were obtained by area under the curve, intention to treat, and per protocol analysis. Conclusions-Patients older than 60 years with knee osteoarthritis and with significant symptoms corresponding to an index of severity of knee disease of 10 or more, comprise the group most likely to benefit from treatment with intra-articular hyaluronan injections.</p>},
  author       = {Lohmander, L. Stefan and Dalén, Nils and Englund, Gunnar and Hämäläinen, Martti and Jensen, Erik Martin and Karlsson, Kerstin and Odensten, Magnus and Ryd, Leif and Sernbo, Ingemar and Suomalainen, Olavi and Tegnander, Agnar},
  issn         = {0003-4967},
  language     = {eng},
  number       = {7},
  pages        = {424--431},
  publisher    = {ARRAY(0x8289048)},
  series       = {Annals of the Rheumatic Diseases},
  title        = {Intra-articular hyaluronan injections in the treatment of osteoarthritis of the knee : A randomised, double blind, placebo controlled multicentre trial},
  volume       = {55},
  year         = {1996},
}