An interventional study of Open Reduction Internal Fixation and Cast immobilisation in Metatarsal Fracture, sponsored by Isala. Status unknown at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-02.
Sponsored by Isala · Not applicable, Interventional, and Treatment
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
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 64 is close to the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Isala is the lead sponsor of 36 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
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
The control group (conservative treatment), will receive a period of cast immobilisation, with a gradual increase in weight bearing by protocol.
Procedure: Cast immobilisation
Surgical intervention by lag screw or plate fixation
Cast immobilsation for a total of 6 weeks with gradual increase in weight bearing after 2 weeks
Numerical rating scale-11 score for pain 3 months
Numerical rating scale, score ranging from 0-10 where 10 is a worse outcome
Time frame: 3 months after intervention
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks, 3,6 and 12 months after intervention
Return to work
Duration of resumption of work
Time frame: 0-12 months
Return to normal footwear
Duration of return to normal footwear
Time frame: 0-12 months
Malunion
Length of fractured fifth metatarsal as compared to ipsilateral fifth metatarsal
Time frame: 6 weeks after intervention
Non union
Determined by plain X-ray on 6 weeks, 3 months and 6 months, categorical outcome
Time frame: 0-6 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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