NCT05450107

Fifth Metatarsal Orthopedic Outcome Trial

Treatment of Fifth Metatarsal Shaft Fractures: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Isala · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Fractures of the shaft, distal to zone three, of the fifth metatarsal often occur after foot distortion. There is very little evidence available regarding the optimal treatment. Currently the most common treatment is prolonged cast immobilization. Operative treatment has been reported as an alternative and could promote early recovery. No comparative study has been published regarding optimal treatment

Detailed description

Objective: The main objective is to determine experienced pain, as measured by NRS-11 score, 3 months after intervention and compare this between the intervention and control group. Secondary objectives are functional outcome as measured by AOFAS Lesser Toe Scale, FAAM score, progress of NRS-11 score through time and PROMIS Mobility/pain interference. Furthermore, quality and duration of fracture healing will be compared between groups. The impact on daily life will be compared as measured by duration of return to work and normal footwear. Study design: Randomised controlled clinical intervention trial Study population: Humans with an acute shaft fracture of the fifth metatarsal bone, 18 years or older.

Conditions

• Metatarsal Fracture

Interventions

Type	Name	Description
PROCEDURE	Open Reduction Internal Fixation	Surgical intervention by lag screw or plate fixation
PROCEDURE	Cast immobilisation	Cast immobilsation for a total of 6 weeks with gradual increase in weight bearing after 2 weeks

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2022-07-08
• Last updated: 2023-03-02

Locations

3 sites across 1 country: Netherlands