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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN75212826

Enrollment

Registered

2005-09-30

Start date

2003-03-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury, Occupational Diseases, Poisoning: Tendon lacerations Injury, Occupational Diseases, Poisoning Tendon lacerations

Interventions

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

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients with acute Zone II flexor tendon lacerations in the hand.

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Tendon rupture rate and digital range of motion at 12 weeks post-repair.	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026