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Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05450107
Study type Interventional
Source Isala
Contact Maarten Cornelissen, MD
Phone 0886248117
Email m.p.cornelissen@isala.nl
Status Recruiting
Phase N/A
Start date September 1, 2022
Completion date December 2024

See also
  Status Clinical Trial Phase
Completed NCT03504462 - Feasibility of Specific Anesthesia of the Forefoot Preserving the Sensitivity of the Heel for Foot Surgery N/A
Recruiting NCT02050698 - Hard-soled Shoe Versus Short Leg Walking Cast for a Fifth Metatarsal Avulsion Fracture: A Randomized Multicenter Noninferiority Trial N/A
Completed NCT04168411 - Comparison Different Method Treatment in Tuberosity Fractures of the Proximal Fifth Metatarsal N/A
Recruiting NCT04847115 - Treatment of Fifth Metatarsal Zone 3 Fractures N/A