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ISRCTN
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ISRCTN75212826
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ClinicalTrials.gov identifier
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Public title
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Comparison of the Teno Fix Tendon Repair System and a standard suture repair in Zone II flexor tendon lacerations of the hand.
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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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N0013145917
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Study hypothesis
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Is there a reduced rupture rate and improved outcome using the Teno Fix Tendon Repair System in comparison to a standard suture repair in zone II flexor tendon lacerations in the hand?
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Lay summary
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Ethics approval
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Not provided at time of registration
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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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Injury, Occupational Diseases, Poisoning: Tendon lacerations
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Participants - inclusion criteria
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Adult patients with acute Zone II flexor tendon lacerations in the hand.
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Participants - exclusion criteria
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1. Adults above 60 yrs of age
2. Flexor tendon lacerations outside Zone 2
3. Complex injuries, eg crush, mutilation, skin loss, amputations, revascularisation
4. The presence of established infection in injured hand
5. Associated digital fractures
6. Delayed surgery
7. Severe intercurrent medical illness
8. Drugs, eg immunosuppressives, steroids, which can affect healing
9. Previous injuries to affected hand
10. Pre-existing arthritis in affected hand
11. Allergy to metals in the stainless steel suture of Teno Fix (chromium, copper, cobalt, nickel, iron)
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Anticipated start date
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01/03/2003
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Anticipated end date
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01/09/2003
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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50
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Interventions
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Randomisation of adult patients with zone II flexor tendon lacerations to receive either the Teno Fix repair or standard suture repair. Assessment of outcomes by blinded, independent observer.
Added 29 July 2008: trial stopped in 2006 due to poor recruitment.
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Primary outcome measure(s)
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Tendon rupture rate and digital range of motion at 12 weeks post-repair.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Guy's and St. Thomas' NHS Foundation Trust (UK) Own account
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Trial website
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Publications
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Contact name
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Mr
C
Healy
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Address
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Plastic Surgery
4th Floor, South Wing (Block 7)
St. Thomas' Hospital
Lambeth Palace Road
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City/town
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London
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Zip/Postcode
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SE1 7EH
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Country
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United Kingdom
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Tel
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+44 (0)20 7188 5136
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Fax
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+44
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Email
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Ciaran.healy@gstt.sthames.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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26/04/2011
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Date ISRCTN assigned
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30/09/2005
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