calcaneal fractures heel bone fractures heel bone fracture
Conditions
Interventions
The PWB protocol allows earlier post-operative permissive weight bearing, where
progression of weight bearing is guided by the subjective experience (for
example: pain, weight bearing tolerance) of
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Surgically treated trauma patients with isolated unilateral DIACFs, less than 6 weeks after trauma, Sanders type II-IV • Isolated unilateral calcaneal fractures • Age between 18 and 67 years old (labor force) • Being able to understand the questionnaires and measurement instructions • Indication for open/closed reduction and internal fixation • Written Informed Consent
Exclusion criteria
Exclusion criteria: • Acute or existing amputation (upper limb, lower limb, feet) • Open calcaneal fractures (excluding medial wound without compromising surgical approach) • Bilateral fractures of the lower extremities • Unable to comply to the PWB protocol due to pre-existing conditions of the arms and legs (e.g. unable to use crotches due to hemiparalysis) • Severe non-fracture related comorbidity of the lower extremity • Pre-existent immobility (loss of muscle function of one or both legs) • Dependent in activities of daily living (e.g. due to dementia, Alzheimer, New York Heart Association class IV angina and heart failure, oxygen-dependent chronic obstructive pulmonary disease) • Rheumatoid arthritis of the lower extremities • Severe psychiatric comorbidities that lead to inability to comply with the treatment protocol • Pathologic fractures (metastasis, secondary osteoporosis) • Peripheral neuropathy and/or diabetes • Alcohol- or drug abuse preventing adequate follow-up • Primary indication for arthrodesis subtalar joint • Two or more fractures of the upper and/or lower extremities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective is: - Is functional outcome in PWB in surgically treated patients with DIACFs non-inferior to RWB after 6 months, as defined by the American Orthopaedic Foot & Ankle Society (AOFAS) Score? Hypothesis 1: functional outcome, as defined by the AOFAS Score, for surgically treated patients with DIACFs following the PWB protocol is non-inferior compared to patients who followed the RWB protocol after 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Are there differences in self-reported function in surgically treated patients with DIACFs following the PWB protocol compared to patients following the RWB protocol after 6 months? - Are there differences in Health-Related Quality of Life (HRQoL) assessed by EuroQol-5D-5L in surgically treated patients with DIACFs following the PWB protocol compared to patients following the RWB protocol after 6 months? - Is there a difference between the pre-operative and early post-operative Böhlers angle between surgically treated patients with DIACFs following the PWB or RWB protocol? Is there a difference between the early post-operative Böhlers angle and the Böhlers angle at 6 months post-operatively between surgically treated patients with DIACFs following the PWB or RWB protocol? Is there a difference in the the posterior facet joint alignment (step-off and gap) when compared at 6 months between surgically treated patients with DIACFs following the PWB or RWB protocol? - Is the PWB protocol cost-effective in surgically treated patients with DIACFs compared to RWB? - Is there a difference in the occurrence of complications after 6 months between surgically treated patients with DIACFs following the PWB or RWB protocol? Hypothesis 2: patients with DIACFs following the PWB protocol will have better self-reported function as defined by the Maryland Foot Score (MFS) than patients who followed the RWB protocol after 6 months. Hypothesis 3: patients with DIACFs following the PWB will have an improved HRQoL defined by the EuroQoL 5-Dimension 5-Level (EQ-5D) than patients who followed the RWB protocol after 6 months. Hypothesis 4: patients with DIACFs following the PWB will have no radiographically differences in comparison to patients following the RWB protocol when the intra-articular step-off (in mm) and gap (in mm) of the posterior facet and the Böhlers angle (in degrees) is compared between 6 months and directly post-operatively. Hypothesis 5: he | — |
Countries
Netherlands
Contacts
Public ContactC Verstappen
Maastricht Universitair Medisch Centrum +
Outcome results
None listed