Comparative efficacy of Fish Rod External fixator and Conventional Triangular External Fixator in the Staged Treatment of Distal Tibia fracture

Comparative efficacy of a Fish rod External Fixator and Conventional Triangular External Fixator in the Staged Treatment of Distal Tibia Fractures, A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250527007

Enrollment

Registered

2025-05-27

Start date

2023-09-25

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Distal Tibia Fracture Distal Tibia fracture ,Triangular External fixator, Fish-rod External fixator

Interventions

Spanning ankle External fixator as a first stage treatment for distal tibia fracture. Device construct consists of pre-molded metal rod, Schanz pin 6.0 mm, Bar-to-bar clamp, Pin-to-bar clamp, Kirschn

Experimental Device,Active Comparator Device

Fish-rod ankle External fixator,Conventional Triangular ankle External fixator

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Diagnosis of Closed Distal tibia fracture AO/OTA 43B,C 2. Admitted in Chonburi Hospital

Exclusion criteria

Exclusion criteria: 1.non-ambulatory patient 2. Deny surgery or ineligible candidate for surgery 3. Had previous surgery or fracture in ipsilateral ankle or leg 4. Pathologic fracture 5. Active infection or malignancy

Design outcomes

Primary

Measure	Time frame
Loss of Reduction Until Device Removal Radiographic ,Infection rate Until Radiologic union Clinical diagnosis	—

Secondary

Measure	Time frame
Operative time for External fixation at First stage of fixation Operative record ,Operative time for Definitive surgery at Second stage of fixation Operative record ,Radiation exposure time at First stage of Fixation Collected from Operative re3cord and Fluoroscopic device ,Time until no swelling of ankle During Device retention Clinical diagnosis,Reduction quality after time of Definite fixation Radiologic criteria	—

Measure

Time frame

Operative time for External fixation at First stage of fixation Operative record ,Operative time for Definitive surgery at Second stage of fixation Operative record ,Radiation exposure time at First stage of Fixation Collected from Operative re3cord and Fluoroscopic device ,Time until no swelling of ankle During Device retention Clinical diagnosis,Reduction quality after time of Definite fixation Radiologic criteria

—

Countries

Thailand

Contacts

Public ContactPawee Asawakittiporn

Chonburi hospital

pawee.asw@gmail.com0823414903

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026