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 |
| Secondary identifying numbers | N0013145917 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 26/04/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Injury, Occupational Diseases, Poisoning
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
Contact information
Mr C Healy
Scientific
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 |
|---|---|
| Ciaran.healy@gstt.sthames.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | Tendon rupture rate and digital range of motion at 12 weeks post-repair. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/03/2003 |
| Completion date | 01/09/2003 |
| Reason abandoned (if study stopped) | Poor recruitment |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Plastic Surgery
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Guy's and St. Thomas' NHS Foundation Trust (UK) Own account
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
