The main objective is to determine function/clinical outcome, measured by the NRS-11 score for pain, 3 months after intervention and compare this between the surgery and conservative group. Secondary objectives are functional outcome as measured by…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is difference in NRS-11 score for pain between the two
groups at three months. This is a patient reported rating scale, resulting in a
score ranging from 0-10 where 10 is the worst pain ever experienced.
Secondary outcome
Impact on daily living will be measured by
* Return to work
* Return to normal footwear
Impact on fracture healing will be measured by
* Malunion of the fracture
* Non-union of the fracture
* Complication rate
Functional outcome will be measured by the questionnaires
* FAAM
* PROMIS
* AOFAS LTS
* NRS-11 measured across the different timepoints of the follow up (6
weeks. 3, 6 and 12 months)
Background summary
Fractures of the shaft of the fifth metatarsal often occur after foot
distortion. Yet 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.
Study objective
The main objective is to determine function/clinical outcome, measured by the
NRS-11 score for pain, 3 months after intervention and compare this between the
surgery and conservative group. Secondary objectives are functional outcome as
measured by FAAM score, AOFAS LTS and PROMIS Mobility and 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
Randomized controlled clinical intervention trial
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 immobilization with gradual increase of weight bearing will
commence.
The control group (conservative treatment), will receive a period of cast
immobilization, with a gradual increase in weight bearing by protocol.
Study burden and risks
The intervention group will undergo surgery as described in the section
''intervention''
The intervention group is exposed to the common risks associated with the
surgical procedure such as: Infection of the incision site or osteosynthesis
material, local paraesthesia and the risks of anaesthesia. Both groups are at
risk of developing deep venous thrombosis. The control group is at risk of
complex regional pain syndrome. In both groups risks are all low to negligible.
The benefit for the intervention group can be less persisting pain and earlier,
or at least equally fast, functional recovery compared to the control group.
These benefits are expected to be present in the vast majority of the group.
Thus the benefits are deemed to outweigh the risks.
The participants will have to fill out questionnaires at six weeks, three, six
and 12 months after inclusion. These questionnaires will take 20 minutes max in
total. The questions will not concern any burdensome topics such as sexuality
or very personal information.
If no benefit is seen the clinical equipoise can be resolved and current
treatment will be continued, preventing further exposure to the risks of
surgical treatment.
Dr. Van Heesweg 2
Zwolle 8025 AB
NL
Dr. Van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
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
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 | NL80748.075.22 |
| Other | volgt |