Fifth Metatarsal Orthopedic Outcome Trial (FOOT)

Isala

Status: Enrolling

Conditions: Metatarsal Fracture

Treatments: Procedure: Cast immobilisation; Procedure: Open Reduction Internal Fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT05450107

80748.075.22

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Intervention

Experimental group

Description:

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 plate fixation. After surgery a period of cast immobilisation with gradual increase of weight bearing will commence

Treatment:

Procedure: Open Reduction Internal Fixation

Control

Active Comparator group

Description:

The control group (conservative treatment), will receive a period of cast immobilisation, with a gradual increase in weight bearing by protocol.

Treatment:

Procedure: Cast immobilisation