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ISRCTN
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ISRCTN71676516
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial to compare the functional outcome of the standard NexGen Legacy knee replacement to that of the NexGen Legacy Flex knee replacement which is designed to allow a greater range of flexion in the knee
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Scientific title
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Acronym
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N/A
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Serial number at source
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Z0002
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Study hypothesis
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Does the use of the NexGen Legacy Flex knee replacement produce significantly better outcomes than those obtained with the standard NexGen Legacy knee replacement ?
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Ethics approval
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The study was approved by the Lothian Research Ethics Committee on 17/2/2004 (ref: LREC2003/1/36).
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Study design
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Prospective, double blind, randomised controlled trial.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Total knee replacement surgery in patients with osteoarthritis
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Participants - inclusion criteria
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Patients with knee osteoarthritis who are on the waiting list to undergo unilateral total knee arthroplasty at the New Royal Infirmary in Edinburgh and who can passively flex their knee 90 degrees or more.
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Participants - exclusion criteria
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1. Inflammatory polyarthritis
2. Disorders of the feet, hips or spine causing abnormal gait or significant pain
3. Dementia
4. Severe visual impairment
5. Neurological conditions affecting movement
6. Inability to give informed consent
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Anticipated start date
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01/03/2004
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Anticipated end date
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31/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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80, 40 in each group
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Interventions
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Standard NexGen Legacy knee replacement versus the NexGen Legacy Flex knee replacement
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Primary outcome measure(s)
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Functional range of movement of the knee using flexible electrogoniometry
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Secondary outcome measure(s)
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1. Passive range of motion
2. Pain
3. Knee extensor and flexor strength
4. Walking speed
5. Woman on the Move Against Cancer (WOMAC)
6. Knee Society Score
7. Daily Physical Activity
8. Quality of Life
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Sources of funding
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Zimmer UK Ltd (ref: Z0002)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18160497
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Contact name
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Dr
Marietta
van der Linden
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Address
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School of Health Sciences
Queen Margaret University College
Duke Street
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City/town
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Edinburgh
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Zip/Postcode
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EH6 8HF
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Country
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United Kingdom
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Tel
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+44 (0)131 3173820
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Email
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mvanderlinden@qmuc.ac.uk
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Sponsor
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Queen Margaret University College (UK)
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Address
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Clerwood Terrace
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City/town
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Edinburgh
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Zip/Postcode
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EH12 8TS
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Country
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United Kingdom
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Tel
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+44 (0)131 3173000
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Email
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whardcastle@qmuc.ac.uk
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Sponsor website:
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http://www.qmuc.ac.uk
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Date applied
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13/10/2006
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Last edited
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27/06/2008
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Date ISRCTN assigned
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04/12/2006
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