Primary objective:Difference in AOFAS lesser increase scale after 3 months.Secondary objectives:VAS pain scoresFracture Consolidation PeriodDelayed unionLength MT-V measured at contralateral MT-V, malunionQuestionnaire FAAM
ID
Source
Brief title
(Fifth metatarsal Orthopaedic Outcome Trial)
Condition
- Fractures
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in functional outcome using AOFAS lesser toe scale
Secondary outcome
Difference in fracture consolidation period in both groups
Difference in VAS scores
The level of delayed and non-union in fracture
Registration of complications
FAAM score
Background summary
The treatment of fractures of the shaft of the fifth metatarsal (MT-V) is in
most cases a conservative treatment. Only in angulated and/or dislocated
fractures a surgical treatment is indicated. The surgical treatment is open
reposition and internal fixation. Literature contains only one retrospective
study, includes 35 patients of whom 31 were treated conservatively. The four
operated patients were treated with K-wire fixation.
There is no good prospective randomized study of the treatment of fifth
metatarsal mid-shaft fractures. We want to perform a prospective randomized
trial in the outcome of conservative versus operative treatment of fifth
metatarsal mid-shaft fractures.
Study objective
Primary objective:
Difference in AOFAS lesser increase scale after 3 months.
Secondary objectives:
VAS pain scores
Fracture Consolidation Period
Delayed union
Length MT-V measured at contralateral MT-V, malunion
Questionnaire FAAM
Study design
This is a prospective randomized trial. Patients with a fifth metatarsal
mid-shaft fracture will be included. At Inclusion, with informed consent,
standard X-rays are made. Questionnaires will be filled in. Randomisation for
treatment. This is either the conservative treatment or surgical treatment.
Conservative treatment consists of 2 weeks LU-splint and 4 weeks forefoot
relieving shoe.
The surgical treatment is open reduction and internal fixation (ORIF).,
followed with 2 weeks LU-splint and 4 weeks forefoot relieving shoe.
During the treatment period the patient will have a "pain diary", consisting
that each week an average pain VAS score is scored.
After the first treatment period of 6 weeks questionnaires filled in and
radiographs are taken, including the contralateral foot to evaluate MT-V length.
Follow-up after 3 months, 6 months and 1 year.
The maximum follow-up is 1 year.
Intervention
Conservative treatment consists of 2 weeks LU-splint and 4 weeks forefoot
relieving shoe.
The surgical treatment is open reduction and internal fixation (ORIF).,
followed with 2 weeks LU-splint and 4 weeks forefoot relieving shoe.
Study burden and risks
The extent of the burden in both groups:
6 times outpatient visit with questionnaires and Xrays
first 6 weeks (during treatment), a weekly VAS is scored
Extent of the burden in the surgical group:
Admission in hospital
The operation itself
Risks:
Surgical risks, such as a wound infection
Helene Swarthlaan 106
9721 TZ Groningen
NL
Helene Swarthlaan 106
9721 TZ Groningen
NL
Listed location countries
Age
Inclusion criteria
Patient with dislocated distal shaft fifth metatarsal fracture
above 18 years-old
Informed consent
Exclusion criteria
clinical relevant vascular and/or neurological disorders
previous foot surgery
Rheumatoid arthritis
Unable to undergo surgery
Not being able to visit the clinic
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34571.075.11 |