Vroegtijdig belasten na niet-geopereerde botbreuk van de enkel

SUMMARY PANCAKE TRIAL

Rationale: There is controversy about the optimal conservative treatment of common stable
ankle fractures (Weber B or Lauge-Hansen supination-eversion stage 2-4A). The current
international guideline describes non-weight bearing and immobilization with a plaster cast
for 6 weeks. However, the literature provides no substantiation for this period of non-weight
bearing.

Hypothesis 1: We expect earlier functional outcomes in the intervention group than in the
control group. Hypothesis 2: We expect the number of complications not to be higher in the
intervention group than in the control group. Hypothesis 3: We expect the long-term recovery
function (3 months) in the intervention group not to be worse than in the control group. Null
hypothesis 1: The treatment in the intervention group is not as effective as the treatment in
the control group, because there are worse functional outcomes in the intervention group
than in the control group. Null hypothesis 2: The treatment in the intervention group is not as
safe as the treatment in the control group, because there are more dislocations of the
fractures reported in the intervention group than in the control group.

Objective: What are the 6-week and 12-week effects on the functional outcome scores of
the ankle in early weight bearing (mobilization with Walker) compared to 6 weeks non-weight
bearing and immobilization in conservatively treated stable ankle fractures (Weber B or
Lauge Hansen supination-eversion stage 2-4A)?

Study design: A prospective randomized controlled trial at the Zuyderland Medical Center.
We will include patients at both locations, Heerlen and Sittard/Geleen.

Study population: Men and women, 16 years or older, with Weber B ankle fractures treated
with a dorsal lower limb cast at the emergency department of both locations of the
Zuyderland Medical Center, Heerlen and Sittard/Geleen, The Netherlands.

Intervention: One group will get a Walker by which they can start with permissive weight
bearing. The other group will get a circular lower limb plaster cast and instructions of non-
weight bearing and immobilization till the next visit. After 6 weeks, the Walker or plaster cast
will be removed. The patients may then extend the weight bearing to functional.

Main study parameters/endpoints: The primary parameter in this study is functional
outcome score of the ankle. Secondary parameter is dislocation of the fracture. Other
parameters are range of motion of the ankle, circumference of the calf, return to work,
satisfaction of the patient and other complications, such as deep vein thrombosis or surgery.
Nature and extent of the burden and risks associated with participation, benefit an
group relatedness: 3 site visits during 12 weeks with physical examinations and 2
questionnaires which have to be filled in during each visit. Risks of the investigational
treatment are myalgia and dislocation of the fracture.

Hypothesis 1: We expect earlier functional outcomes in the intervention group than in the control group. Hypothesis 2: We expect the number of complications not to be higher in the intervention group than in the control group. Hypothesis 3: We expect the long-term recovery function (3 months) in the intervention group not to be worse than in the control group.

T1 (= baseline): 7-10 days posttrauma

T2: 6 weeks posttrauma

T3: 12 weeks posttrauma

One group will get a Walker by which they can start with permissive weight bearing. The other group will get a circular lower limb plaster cast and instructions of non-weight bearing and immobilization till the next visit. After 6 weeks, the Walker or plaster cast will be removed. The patients may then extend the weight bearing to functional.