Fifth Metatarsal Orthopedic Outcome Trial

Study Overview
=================
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.

Official Title
-----------------
Treatment of Fifth Metatarsal Shaft Fractures: A Randomized Controlled Trial

Conditions
-----------------
Metatarsal Fracture

Intervention / Treatment
-----------------
* Procedure: Open Reduction Internal Fixation
* Procedure: Cast immobilisation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled clinical intervention trial
Masking: None (Open Label)


Arms and Interventions

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

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 |