Fifth Metatarsal Orthopedic Outcome Trial

Isala64 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metatarsal Fracture

Interventions

Open Reduction Internal FixationPROCEDURE

Surgical intervention by lag screw or plate fixation

Cast immobilisationPROCEDURE

Cast immobilsation for a total of 6 weeks with gradual increase in weight bearing after 2 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Rijnstate ziekenhuis

Arnhem, Gelderland, Netherlands

RECRUITING

IsalaK

Zwolle, Overijssel, Netherlands

RECRUITING

Martini ziekenhuis

Groningen, Netherlands

RECRUITING

Outcomes

Primary Outcomes

Numerical rating scale-11 score for pain 3 months

Numerical rating scale, score ranging from 0-10 where 10 is a worse outcome

Time frame: 3 months after intervention

Secondary Outcomes

Numerical rating scale-11 score for pain through time

Numerical Rating Scale-11 score progression through different time points (6 weeks, 3,6 and 12 months after intervention. Score ranging from 0-10. A Higher score is a worse outcome

Time frame: 0-12 months after intervention

American Orthopedic Foot &Ankle Society Lesser Toe Scale

American Orthopedic Foot \&Ankle Society Lesser Toe Scale between groups, functional outcome measure for patients with lesser toe (i.e. excluding hallux) and midfoot pathology. Score ranging from 0-100. A Higher score is a better outcome

Time frame: 3 months after intervention

Foot and Ankle Ability Measure

Foot and Ankle Ability Measure, a score with two subscales: Activities of Daily Living (ADL) and sports. The questions concern function of the foot and ankle. progression through different time points (6 weeks, 3,6 and 12 months after intervention). Score ranging from 0-120. A higher score is a better outcome

Time frame: 6 weeks, 3,6 and 12 months after intervention

Patient Reported Outcome Measure Information System - Mobility

patient reported outcome measures by using Computer Adaptive Testing. Results in a normalized score ranging from 0-100 where an average human being will score 50. Higher score is a better outcome.

Time frame: 6 weeks, 3,6 and 12 months after intervention

Patient Reported Outcome Measure Information System - Pain Interference

Central Contacts

Maarten Cornelissen, MD

CONTACT

0886248117 m.p.cornelissen@isala.nl

Roelina Munnik-Hagewoud, PhD

CONTACT

0886245375 r.munnik@isala.nl

Data from ClinicalTrials.gov

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