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Fifth Metatarsal Orthopedic Outcome Trial (FOOT)

Primary Purpose

Metatarsal Fracture

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Open Reduction Internal Fixation
Cast immobilisation
Sponsored by
Isala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metatarsal Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rijnstate ziekenhuisRecruiting
  • IsalaKRecruiting
  • Martini ziekenhuisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm 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

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

Outcomes

Primary Outcome Measures

Numerical rating scale-11 score for pain 3 months
Numerical rating scale, score ranging from 0-10 where 10 is a worse outcome

Secondary Outcome Measures

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
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
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
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.
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.
Return to work
Duration of resumption of work
Return to normal footwear
Duration of return to normal footwear
Malunion
Length of fractured fifth metatarsal as compared to ipsilateral fifth metatarsal
Non union
Determined by plain X-ray on 6 weeks, 3 months and 6 months, categorical outcome

Full Information

First Posted
July 4, 2022
Last Updated
February 28, 2023
Sponsor
Isala
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1. Study Identification

Unique Protocol Identification Number
NCT05450107
Brief Title
Fifth Metatarsal Orthopedic Outcome Trial
Acronym
FOOT
Official Title
Treatment of Fifth Metatarsal Shaft Fractures: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metatarsal Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical intervention trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm 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
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group (conservative treatment), will receive a period of cast immobilisation, with a gradual increase in weight bearing by protocol.
Intervention Type
Procedure
Intervention Name(s)
Open Reduction Internal Fixation
Intervention Description
Surgical intervention by lag screw or plate fixation
Intervention Type
Procedure
Intervention Name(s)
Cast immobilisation
Intervention Description
Cast immobilsation for a total of 6 weeks with gradual increase in weight bearing after 2 weeks
Primary Outcome Measure Information:
Title
Numerical rating scale-11 score for pain 3 months
Description
Numerical rating scale, score ranging from 0-10 where 10 is a worse outcome
Time Frame
3 months after intervention
Secondary Outcome Measure Information:
Title
Numerical rating scale-11 score for pain through time
Description
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
Title
American Orthopedic Foot &Ankle Society Lesser Toe Scale
Description
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
Title
Foot and Ankle Ability Measure
Description
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
Title
Patient Reported Outcome Measure Information System - Mobility
Description
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
Title
Patient Reported Outcome Measure Information System - Pain Interference
Description
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
Title
Return to work
Description
Duration of resumption of work
Time Frame
0-12 months
Title
Return to normal footwear
Description
Duration of return to normal footwear
Time Frame
0-12 months
Title
Malunion
Description
Length of fractured fifth metatarsal as compared to ipsilateral fifth metatarsal
Time Frame
6 weeks after intervention
Title
Non union
Description
Determined by plain X-ray on 6 weeks, 3 months and 6 months, categorical outcome
Time Frame
0-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maarten Cornelissen, MD
Phone
0886248117
Email
m.p.cornelissen@isala.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Roelina Munnik-Hagewoud, PhD
Phone
0886245375
Email
r.munnik@isala.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rutger Zuurmond, MD, PhD
Organizational Affiliation
Isala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate ziekenhuis
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6815AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annika Willems
Phone
088005888
Email
orthopedicresearch@rijnstate.nl
Facility Name
IsalaK
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8025AB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maarten Cornelissen, MD
Phone
0886248117
Email
onderzoek.orthopedie@isala.nl
First Name & Middle Initial & Last Name & Degree
Roeliena Munnik-Hagewoud, PhD
Phone
0886245375
Email
r.munnik@isala.nl
Facility Name
Martini ziekenhuis
City
Groningen
ZIP/Postal Code
9728NT
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Astrid De Vries, PhD
Phone
0505245960
Email
A.deVries3@mzh.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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Fifth Metatarsal Orthopedic Outcome Trial

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