Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
26/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes