Contact information
Type
Scientific
Primary contact
Mr C Healy
ORCID ID
Contact details
Plastic Surgery
4th Floor
South Wing (Block 7)
St. Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
+44 (0)20 7188 5136
Ciaran.healy@gstt.sthames.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0013145917
Study information
Scientific title
Acronym
Study hypothesis
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?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Injury, Occupational Diseases, Poisoning: Tendon lacerations
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Tendon rupture rate and digital range of motion at 12 weeks post-repair.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2003
Overall trial end date
01/09/2003
Reason abandoned
Poor recruitment
Eligibility
Participant inclusion criteria
Adult patients with acute Zone II flexor tendon lacerations in the hand.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
50
Participant exclusion criteria
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)
Recruitment start date
01/03/2003
Recruitment end date
01/09/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Plastic Surgery
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Guy's and St. Thomas' NHS Foundation Trust (UK) Own account
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary