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Comparative Study in Conservative Treatment of Right Fifth Metatarsal Fracture, Rapid Returns to Drive: a randomized controlled trial

Early Weight Bearing with Orthopaedic Shoe for Treatment of Fifth Metatarsal Fracture Rapid Returns of Driving: a randomized controlled trial

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240403001
Enrollment
68
Registered
2024-04-03
Start date
2022-10-28
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

Patient with Rt 5th MTB fracture age 18-70 years Rt 5th MTB fracture BRT

Interventions

Patient with Rt 5th MTB fracture wearing short Ortholife air walking boot ambulate weight bearing as tolerate F/U at 2wk, 6wk, 12wk to evaluate BRT[at 2wk, 6wk use boot at 12wk use regular shoe], Fi
Active Comparator Device,Active Comparator Device
CAM walker boots,Orthopaedic shoe

Sponsors

Funding from research department, mahidol university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patient with closed Rt 5th MTB fracture, able to conservative 2.Perform treatment in Siriraj hospital, Nakhonpathom hospital 3.age 18-70 years 4.able to drive a car

Exclusion criteria

Exclusion criteria: 1.closed Rt 5th MTB fracture Torg zone 3, stress fracture 2.Rt lower limb injury/surgery with in 3 months 3.underlying which unable to drive eg. Epilepsy, psychosis, muscle weakness 4.using drug/medication which decrease ability to drive 5.closed Rt 5th MTB fracture Trog zone 2 and displaced more than 2mm or intraarticular fracture through 5th TMT joint

Design outcomes

Primary

MeasureTime frame
BRT: Break response time 2wk, 6wk, 12wk after injury[patient F/U at 2wk, 6wk use shoe device and at 12wk use regular shoe] millisecond/ the BRT device is validated at the department of transport of Thailand, we advice patient to demo test for 1 time then test for 3 times, with 30sec break each the data is the mean of 3

Secondary

MeasureTime frame
Union rate of fracture 2wk, 6wk, 12wk Weeks/ all x-ray are evaluate by one orthopedic resident, the criteria of union rate is seen callus in 3 cortex out of 4 cortex[anterior, posterior, medial, lateral],FAAM score[Foot and Ankle Ability Measurement score] 2wk, 6wk, 12wk Point/ the research assistance will read the questionnaire for the patient eg. walk on flat surface, walk up and down stair and patient rating from 0-6 then calculate in https://orthotoolkit.com/faam ,Return to activity time 2wk, 6wk, 12wk, 6month, 12 month weeks-months/ the research assistance will call the patient by phone to ask about periods of time that patient able to fully return to pre-injury status,Satisfaction of Foot Orthosis 2wk, 6wk, 12 wk Point/the research assistance will read the questionnaire for the patient eg. comfortable, appearance, weight of device[orthopaedice shoe, boot] and patient rating from 0-10 ,Pain 2wk, 6wk, 12wk Point/VAS:visual analog score,Ankle Range of motion 12wk Degree/patient will be asked to remove the device and dorsiflexion/plantarflexion and measure by goniometer to evaluate the ankle ROM

Countries

Thailand

Contacts

Public ContactPitchapa Siritattamrong

Faculty of Medicine Siriraj hospital, Mahidol university

pitchapa.esp@gmail.com66936922665

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026