Clinical trial NCT05450107: Fifth Metatarsal Orthopedic Outcome Trial
Official title: Treatment of Fifth Metatarsal Shaft Fractures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metatarsal Fracture
Lead sponsor: Isala
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical intervention trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numerical rating scale-11 score for pain 3 months
timeFrame: 3 months after intervention
Secondary outcomes:
measure: Numerical rating scale-11 score for pain through time
timeFrame: 0-12 months after intervention
measure: American Orthopedic Foot &Ankle Society Lesser Toe Scale
timeFrame: 3 months after intervention
measure: Foot and Ankle Ability Measure
timeFrame: 6 weeks, 3,6 and 12 months after intervention
measure: Patient Reported Outcome Measure Information System - Mobility
timeFrame: 6 weeks, 3,6 and 12 months after intervention
measure: Patient Reported Outcome Measure Information System - Pain Interference
timeFrame: 6 weeks, 3,6 and 12 months after intervention
measure: Return to work
timeFrame: 0-12 months
measure: Return to normal footwear
timeFrame: 0-12 months
measure: Malunion
timeFrame: 6 weeks after intervention
measure: Non union
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate ziekenhuis
state: Gelderland
city: Zwolle
country: Netherlands
facility: IsalaK
state: Overijssel
city: Groningen
country: Netherlands
facility: Martini ziekenhuis
Study officials:
affiliation: Isala
name: Rutger Zuurmond, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: