Comparison of the Teno Fix Tendon Repair System and a standard suture repair in Zone II flexor tendon lacerations of the hand.

ISRCTN	ISRCTN75212826
DOI	https://doi.org/10.1186/ISRCTN75212826
Protocol serial number	N0013145917
Sponsor	Department of Health
Funder	Guy's and St. Thomas' NHS Foundation Trust (UK) Own account

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr C Healy
Scientific

Plastic Surgery
4th Floor, South Wing (Block 7)
St. Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Phone	+44 (0)20 7188 5136
Email	Ciaran.healy@gstt.sthames.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Tendon rupture rate and digital range of motion at 12 weeks post-repair.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/09/2003
Reason abandoned (if study stopped)	Poor recruitment

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	50
Key inclusion criteria	Adult patients with acute Zone II flexor tendon lacerations in the hand.
Key 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)
Date of first enrolment	01/03/2003
Date of final enrolment	01/09/2003

Plastic Surgery

London
SE1 7EH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan