Fifth Metatarsal Orthopedic Outcome Trial

Metatarsal Fracture Clinical Trial

— FOOT  

Official title:

Treatment of Fifth Metatarsal Shaft Fractures: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05450107
• Other study ID #: 80748.075.22
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Isala
• Contact: Maarten Cornelissen, MD
• Phone: 0886248117
• Email: m.p.cornelissen[@]isala.nl
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Metatarsal Fracture

Intervention

Procedure:
• Open Reduction Internal Fixation
Surgical intervention by lag screw or plate fixation
• Cast immobilisation
Cast immobilsation for a total of 6 weeks with gradual increase in weight bearing after 2 weeks

Locations

Country	Name	City	State
Netherlands	Rijnstate ziekenhuis	Arnhem	Gelderland
Netherlands	Martini ziekenhuis	Groningen
Netherlands	IsalaK	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Isala

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Return to work	Duration of resumption of work	0-12 months
Secondary	Return to normal footwear	Duration of return to normal footwear	0-12 months
Secondary	Malunion	Length of fractured fifth metatarsal as compared to ipsilateral fifth metatarsal	6 weeks after intervention
Secondary	Non union	Determined by plain X-ray on 6 weeks, 3 months and 6 months, categorical outcome	0-6 months