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Conservative versus Surgical Treatment for Displaced, Distal, Diaphyseal-metaphyseal Fifth Metatarsal Fractures: A Prospective, Randomized, Multicenter Study

Conservative versus Surgical Treatment for Displaced, Distal Diaphyseal-metaphyseal Fifth Metatarsal Fractures: A Prospective, Randomized, Multicenter Study

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210812002
Enrollment
28
Registered
2021-08-12
Start date
2021-06-05
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

Union time in patients with displaced, distal, diaphyseal-metaphyseal fifth metatarsal fractures. Functional out come in patients with displaced, distal, diaphyseal-metaphyseal fifth metatarsal fractures. Bone fractures Metatarsal bone Fracture fixation, internal Conservative treatment

Interventions

The volunteers will be treated with a surgical procedure, that is an open reduction internal fixation with mid foot locking plate and screws. After surgery, the volunteers will be applied with a short
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
Surgical treatment with open reduction and internal fixation,Conservative treatment

Sponsors

Maha Vajiralongkorn foundation
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age minimum 20 years 2. Have a diagnosis of the isolated, closed, distal, diaphyseal-metaphyseal fifth metatarsal fracture with displacement 2 to 5 mm or angulation more than 10 degrees or shortening more than 1 mm 3. Have a diagnosis within 2 weeks after injury

Exclusion criteria

Exclusion criteria: 1. Have a previous history of ipsilateral leg or foot fractures or abnormalities 2. Pathologic fractures 3. Have a history of peripheral neuropathy 4. Poor controlled DM 5. Cannot walk such as cerebrovascular diseases 6. The volunteer cannot follow up at least 12 mouths

Design outcomes

Primary

MeasureTime frame
Union time (week) 8 weeks after treatment, then repeat every 3 weeks until union occurs Weigh bearing CT scan of foot

Secondary

MeasureTime frame
Union rate 6 months Count of non-union case, by a weight bearing CT scan of the foot,Functional outcomes Pre-treatment, 6 months, 12 months, 2 years FAAM, SF-36, VAS,Complications 6 months, 12 months, 2 years Record of any complication that occurs

Countries

Thailand

Contacts

Public ContactChamnanni Rungprai

Phramonkutklao collage of medicine

Chamnanni@yahoo.com6627639300

Outcome results

None listed

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