Primairy aim:To determine the AOFAS Midfoot functional outcome score after operative or non-operative treatment of patients whou sustained a Lisfranc luxation fracture, with a minimum follow-up of 2 years.Secundairy aims:1. To determine the effect…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
American Orthopaedic Foot Ankle Society (AOFAS) midfoot score
Secondary outcome
- ShortForm-36 (SF-36)
- Visueal Analogue Scale (VAS) for patient satisfaction
- Radiographic evaluation
- Pressure characteristics at different parts of the foot
Background summary
There is stil controversy concerning the best management approach for Lisfranc
luxation fractures. The choice is between conservatieve treatment using Plaster
of Paris, or operative treatment (open surgery, percutaneous approach, primary
arthrodesis). Likewise, the type of osteosynthesis material to be used
(Kirschner wires versus screws) is still undecided. Lisfranc luxation fractures
are considered as unstable fractures. Patients sometimes experience complaints
for a prolonged period of time, and a delayed or inadequate could have
detrimental consequences. Therefore, additional research is needed in order to
identify the best treatment strategy.
Study objective
Primairy aim:
To determine the AOFAS Midfoot functional outcome score after operative or
non-operative treatment of patients whou sustained a Lisfranc luxation
fracture, with a minimum follow-up of 2 years.
Secundairy aims:
1. To determine the effect of operative or non-operative treatment on the
health-related quality of live (SF-36) and overall satisfaction with the
treatment outcome (VAS) of patients who sustained a Lisfranc luxation fracture .
2. To determine the prognostic value oof the degree of fracture reduction
(anatomic reduction or > 2 mm dislocation) and the type of osteosynthesis
material (Kirschner wires or screws) on the functional outcome score.
3. To determine the pressure characteristics of the affected foot versus the
contralateral side in patients treated operatively or non-operatively.
It is expected that patients with surgically managed fractures will a report
higher outcome score and less deviations in pressure characteristics than
patients with conservatively managed fractures.
Study design
Retrospective cohort study
Study burden and risks
Patients will be asked to come to the outpatient department once. During that
visit, three X-rays will be taken both feet (AP, 3/4 and lateral image).
Patients will be asked to complete three questionnaires (AOFAS midfoot, SF-36,
and VAS) and to walk on a pressure mat (2 meter) five times. Due to the
radiation exposure of the X-rays, pregnant women are excluded from
participation.
Postbus 2040
3000 CA Rotterdam
Nederland
Postbus 2040
3000 CA Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
- Isolated Lisfranc luxation fracture (confirmed on X-ray or CT)
- Age 18 years or older, without upper age limit
- Informed consent
- Living in the Netherlands
Exclusion criteria
- Intra-articular calcaneal fracture, talus fracture luxation fracture of the Chopart joint
- Age <18 years
- No permanent address
- Patient not ambulant (e.g., wheelchair and bed-bound)
- No informed consent
- Insufficient comprehension of the Dutch language, in the opinon of the researcher
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 | NL26344.078.08 |