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ISRCTN
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ISRCTN44544446
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ClinicalTrials.gov identifier
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Public title
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Sub-vastus versus Medial parapatellar Arthrotomy for total Knee replacement
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Scientific title
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Acronym
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SMAK
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Serial number at source
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N0158124154
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Study hypothesis
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In patients undergoing primary or tri-compartmental knee replacement the sub-vastus approach is significantly superior to the standard medial parapatelar approach in terms of short and long term knee function.
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Lay summary
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Ethics approval
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Ethical approval was obtained from the local ethics committee for the trial.
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Study design
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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
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Participants - inclusion criteria
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1. They require a bi- or tri- compartmental knee replacement
2. They require a unilateral knee replacement
3. They have given their informed consent
4. The surgeon has no clear preference for either of the approaches
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Participants - exclusion criteria
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1. They need a revision knee replacement
2. They have had, or will require a major arthrotomy in the other knee in a 12 month period
3. They have had previous open surgery in or around the knee in the previous 12 months e.g. high tibial osteotomy, femoal osteotmy, open reduction internal fixation (ORIF) for fracture, patellar realignment, patellectomy and open menisectomy
4. They require a bi-lateral knee replacement at a single visit
5. They have a valgus angle of degrees or more
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Anticipated start date
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01/02/2001
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Anticipated end date
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01/08/2004
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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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231
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Interventions
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Standard medial parapatellar approach or sub-vastus approach for primary bi- or tri- compartmental total knee replacement.
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Primary outcome measure(s)
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Knee Society Score at 52 weeks.
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Secondary outcome measure(s)
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1. EuroQol-5D
2. Western Ontario and McMaster Universities (WOMAC) osteoarthritis index
3. 36-item short form health survey (SF-36)
4. Time to normal activities/return to function
5. Pain
6. Complications
7. Surgeon's ease of exposure
8. Length of hospital stay
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Sources of funding
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NHS R&D Support Funding (UK)
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Trial website
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Publications
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Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/16879741
2. http://www.ncbi.nlm.nih.gov/pubmed/16879744
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Contact name
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Mr
David
Griffiths
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Address
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HOSU Locomotor Directorate
City general UHNST
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City/town
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Stoke-on-Trent
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Zip/Postcode
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ST4 6QG
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Country
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United Kingdom
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Tel
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+44 (0)1782 553102
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Fax
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+44 (0)1782 412236
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Email
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david.griffiths@uhns.nhs.uk
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Sponsor
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University Hospital of North Staffordshire NHS Trust (UK)
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Address
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Trust Headquarters
Princes Road
Hartshill
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City/town
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Stoke-on-Trent
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Zip/Postcode
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ST4 7LN
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Country
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United Kingdom
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Tel
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+44 (0)1782 715444
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Email
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david.griffiths@uhns.nhs.uk
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Sponsor website:
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http://www.uhns.nhs.uk/
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Date applied
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21/11/2005
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Last edited
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22/02/2008
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Date ISRCTN assigned
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22/11/2005
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