Fifth Metatarsal Orthopedic Outcome Trial (FOOT)

Treatment of Fifth Metatarsal Shaft Fractures: A Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Metatarsal Fracture
• Intervention / Treatment: Procedure: Open Reduction Internal Fixation; Procedure: Cast immobilisation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maarten Cornelissen, MD; Phone Number: 0886248117; Email: m.p.cornelissen@isala.nl
• Study Contact Backup: Name: Roelina Munnik-Hagewoud, PhD; Phone Number: 0886245375; Email: r.munnik@isala.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728NT
    • Recruiting
    • Martini Ziekenhuis
    • Contact: Astrid De Vries, PhD; Phone Number: 0505245960; Email: A.deVries3@mzh.nl
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6815AD
      • Recruiting
      • Rijnstate Ziekenhuis
      • Contact: Annika Willems; Phone Number: 088005888; Email: orthopedicresearch@rijnstate.nl
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8025AB
      • Recruiting
      • IsalaK
      • Contact: Maarten Cornelissen, MD; Phone Number: 0886248117; Email: onderzoek.orthopedie@isala.nl
      • Contact: Roeliena Munnik-Hagewoud, PhD; Phone Number: 0886245375; Email: r.munnik@isala.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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	Procedure: Open Reduction Internal Fixation; Surgical intervention by lag screw or plate fixation
Active Comparator: Control; The control group (conservative treatment), will receive a period of cast immobilisation, with a gradual increase in weight bearing by protocol.	Procedure: Cast immobilisation; Cast immobilsation for a total of 6 weeks with gradual increase in weight bearing after 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical rating scale-11 score for pain 3 months	Numerical rating scale, score ranging from 0-10 where 10 is a worse outcome	3 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	6 weeks, 3,6 and 12 months after intervention
Patient Reported Outcome Measure Information System - Pain Interference	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.	6 weeks, 3,6 and 12 months after intervention
Return to work	Duration of resumption of work	0-12 months
Return to normal footwear	Duration of return to normal footwear	0-12 months
Malunion	Length of fractured fifth metatarsal as compared to ipsilateral fifth metatarsal	6 weeks after intervention
Non union	Determined by plain X-ray on 6 weeks, 3 months and 6 months, categorical outcome	0-6 months

Collaborators and Investigators

• Sponsor: Isala
• Investigators: Principal Investigator: Rutger Zuurmond, MD, PhD, Isala

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 80748.075.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No