A randomised clinical pilot trial comparing intramedullary nailing with plate and screw fixation in the treatment of patients with an acute fracture of the distal tibia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN08249684

Enrollment

Registered

2010-07-14

Start date

2008-03-01

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

Topic: Musculoskeletal

Interventions

1. Intramedullary nailing: a nail is inserted in the tibia across the fracture 2. Screw and plate fixation: a plate and screw are used to fix the fracture Follow-up length: 12 months

Eligibility

Inclusion criteria

Inclusion criteria: Not provided at time of registration

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
Disability Rating Index. The principle measurement of the primary outcome measure will be at one year after injury.	—

Secondary

Measure	Time frame
1. American Orthopaedic Foot and Ankle Society Hind foot Scale at 3, 6 and 12 months post-injury 2. Complications including wound dehiscence, infection, mal-union, non-union, reoperations, time in hospital and return 3. EQ-5D at 3, 6 and 12 months post-injury 4. Olerud and Molander ankle score at 3, 6 and 12 months post-injury	—

Countries

United Kingdom

Outcome results

None listed

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