A Double-blind, Randomized, Multi-centre Study of the Efficacy and Safety of a Single Intra-articular Injection With Durolane Compared to Saline in Patients With Unilateral Knee Osteoarthritis
Sponsor study identifier
interventional
218
1 country
1
Study Start
February 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2004
Actual (reported)Study Completion
Not reported
Date not reportedThis was a study that compared Durolane injections to saline injections in the treatment of unilateral osteoarthritis of the knee. The patients were randomly assigned one of the two treatments unaware of which treatment they received. The study was conducted at 13 centers in Germany, the United Kingdom and Sweden. Patients were followed for six weeks after study treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2003
Date type not reportedThis date has not been verified as actual or estimated.
April 2004
Actual (reported)March 5, 2013
Actual (reported)March 7, 2013
Actual (reported)Proportion of responders at 6 weeks.
Proportion of responders was based on the improvement in WOMAC (Western Ontario and McMasters Universities Osteoarthritis Index) pain score.
At 6 weeks after treatment
WOMAC pain score
2 and 4 weeks after treatment
Safety of intraarticular injections of 3 ml Durolane
Through 6 weeks after treatment
WOMAC stiffness score
2, 4 and 6 weeks after treatment
WOMAC physical function score
2, 4 and 6 weeks after treatment
Patient assessed global status
2, 4 and 6 weeks after treatment
Intraarticular injection of 3 ml Durolane.
Intraarticular injection of physiological sodium chloride (0.9% NaCl) solution pH 7.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Southampton General Hospital
Southhampton, Hampshire, SO16 6YD, United Kingdom
Arden NK, Akermark C, Andersson M, Todman MG, Altman RD. A randomized saline-controlled trial of NASHA hyaluronic acid for knee osteoarthritis. Curr Med Res Opin. 2014 Feb;30(2):279-86. doi: 10.1185/03007995.2013.855631. Epub 2013 Nov 5.
Nigel Arden, MD
University Hospital Southampton NHS Foundation Trust
218 participants (actual enrollment reported by the registry).
First Submitted
March 5, 2013
First Posted
March 7, 2013
Study Start
February 2003
Date type not reportedThis date has not been verified as actual or estimated.
Comparison of Effectiveness Between PL and PRP on Knee Osteoarthritis: a Prospective,Randomized,Placebo-controlled Trial
Use of Botox in the Management of Thyroid Related Upper Eyelid Retraction
Contact the study team to confirm eligibility.
Primary Completion
April 2004
Actual (reported)Last Updated
August 25, 2022
Record last verified: 2013-03
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Source: ClinicalTrials.gov.
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