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Treatment of the fifth metatarsal shaft fractures: a randomised controlled trial.

Treatment of the fifth metatarsal shaft fractures: a randomised controlled trial. - FOOT (Fifth metatarsal Orthopedic Outcome Trial)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51375
Enrollment
64
Registered
2022-07-18
Start date
2022-12-19
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

fifth metatarsal shaft fractures fractures of the lesser toe

Interventions

The intervention group is offered surgical treatment of the shaft fracture of the fifth metatarsal bone with ORIF. Depending on the type of shaft fracture this will be either lag screw fixation or p

Sponsors

Isala Klinieken
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 18 years or older at the time of study entry - Informed consent - Competent to participate in follow up and fill out questionnaires - Dislocated (1mm or more on plain radiography) fracture of the shaft, distal from zone 3, of the fifth metatarsal according to the Orthopedic Trauma Association (OTA) classification 87.5.3 A-C

Exclusion criteria

Exclusion criteria: - Open fracture - Proximal fifth metatarsal fracture, Jones fracture - Clinically significant or symptomatic vascular or neurologic pathology on the ipsilateral leg - Former surgery or history of development disorder of the contralateral fifth metatarsal - Multiple fractured metatarsals in the affected foot - Medical history of Rheumatoid Arthritis - Unable to undergo surgical procedure

Design outcomes

Secondary

MeasureTime frame
Impact on daily living will be measured by * Return to work * Return to normal footwear Impact on fracture healing will be measured by * Malunion of the fracture * Non-union of the fracture * Complication rate Functional outcome will be measured by the questionnaires * FAAM * PROMIS * AOFAS LTS * NRS-11 measured across the different timepoints of the follow up (6 weeks. 3, 6 and 12 months)

Primary

MeasureTime frame
The main study endpoint is difference in NRS-11 score for pain between the two groups at three months. This is a patient reported rating scale, resulting in a score ranging from 0-10 where 10 is the worst pain ever experienced.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)