FOOT: Fifth Metatarsal Orthopedic Outcome Trial
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Numerical rating scale-11 score for pain 3 months [3 months after intervention]
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 [0-12 months after intervention]
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 [3 months after intervention]
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 [6 weeks, 3,6 and 12 months after intervention]
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 [6 weeks, 3,6 and 12 months after intervention]
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 [6 weeks, 3,6 and 12 months after intervention]
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 [0-12 months]
Duration of resumption of work
- Return to normal footwear [0-12 months]
Duration of return to normal footwear
- Malunion [6 weeks after intervention]
Length of fractured fifth metatarsal as compared to ipsilateral fifth metatarsal
- Non union [0-6 months]
Determined by plain X-ray on 6 weeks, 3 months and 6 months, categorical outcome
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years or older at the time of study entry
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Informed consent
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Competent to participate in follow up and fill out questionnaires
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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:
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Open fracture
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Proximal fifth metatarsal fracture, Jones fracture
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Clinically significant or symptomatic vascular or neurologic pathology on the ipsilateral leg
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Former surgery or history of development disorder of the contralateral fifth metatarsal
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Multiple fractured metatarsals in the affected foot
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Medical history of Rheumatoid Arthritis
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Unable to undergo surgical procedure
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Isala
Investigators
- Principal Investigator: Rutger Zuurmond, MD, PhD, Isala
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 80748.075.22