Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 |
|
| Control | Active Comparator | The control group (conservative treatment), will receive a period of cast immobilisation, with a gradual increase in weight bearing by protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Reduction Internal Fixation | Procedure | Surgical intervention by lag screw or plate fixation |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maarten Cornelissen, MD | Contact | 0886248117 | m.p.cornelissen@isala.nl | |
| Roelina Munnik-Hagewoud, PhD | Contact | 0886245375 | r.munnik@isala.nl |
| Name | Affiliation | Role |
|---|---|---|
| Rutger Zuurmond, MD, PhD | Isala | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate ziekenhuis | Recruiting | Arnhem | Gelderland | 6815AD | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized controlled clinical intervention trial
Not provided
Not provided
Not provided
Not provided
| Cast immobilisation | Procedure | Cast immobilsation for a total of 6 weeks with gradual increase in weight bearing after 2 weeks |
|
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 |
| IsalaK | Recruiting | Zwolle | Overijssel | 8025AB | Netherlands |
|
| Martini ziekenhuis | Recruiting | Groningen | 9728NT | Netherlands |
|