Evidence showing which aftertreatment protocol is best for both fracture healing and functional outcomes for patients with Displaced Intra-Articular Calcaneal Fractures (DIACFs) is lacking. This study has the aim to answer the question whether…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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: health care and societal perspective, aftertreatment following
PWB will be cost-effective in surgically treated patients with DIACFs as
defined by the Medical Consumption Questionnaire (iMCQ) and the Productivity
Cost Questionnaire (iPCQ), and QALYs using the EQ-5D, compared to patients who
followed the RWB protocol, after 6 months.
Hypothesis 6: the complication rate (see *6. Methods* for complications) is
equal or lower in patients with DIACFs following the PWB compared to patients
following the RWB protocol after 6 months.
Background summary
Of all fractures, 1-2% involve the calcaneus. Often surgical treatment is
needed. Even after successful treatment it requires long rehabilitation with
major impact on daily life and socio-economic aspects. Anatomic surgical
restoration does not prevent gait disturbances or persistent foot pain.
Adequate rehabilitation is mandatory to maximize foot stability.
Study objective
Evidence showing which aftertreatment protocol is best for both fracture
healing and functional outcomes for patients with Displaced Intra-Articular
Calcaneal Fractures (DIACFs) is lacking. This study has the aim to answer the
question whether functional outcome in surgically treated patients with DIACFs
with aftertreatment following the Permissive Weight Bearing protocol (PWB) is
non-inferior compared to Restricted Weight Bearing (RWB), after 6 months
measured with the American Orthopaedic Foot & Ankle Society (AOFAS) Score.
Furthermore, this study hypothesizes that surgically treated patients with
DIACFs following the PWB protocol will have a better self-reported function and
a better health-related quality of life (HRQoL) compared to patients who
followed the RWB protocol. The hypothesis is that there will be lower costs
without any radiographic differences for surgically treated (irrespective of
the used surgical technique) patients with DIACFs following a PWB protocol
comparing to the current AO (Arbeitsgemeinschaft für Osteosynthesefragen)
standard care: the RWB protocol.
Study design
Multi-center randomized controlled trial
Intervention
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 the patient and the clinical
expertise of the treating physician and therapist. Patients allocated to the
PWB protocol start weight bearing after wound healing is achieved
(approximately two weeks after the operation). Consequently, patients are
stimulated to bear as much weight as tolerated by pain and comfort. Treatment
will take place according to the PROMETHEUS protocol (see J.).
Study burden and risks
The PWB protocol aims to restore weight bearing faster than RWB protocol in
DIACFs. Early postoperative weight bearing poses the risk of increased
complications, such as secondary displacement of the fracture or failure of
fracture fixation. Previous analysis of this protocol in other lower extremity
fractures has shown a safe complication rate, although data from prospective
randomized trials in calcaneus fractures is lacking. Follow-up is standardized
according to current trauma guidelines, namely at time points 2, 6, 12 weeks
and 6 months. The radiation exposure for both groups will differ from standard
care (one extra CT scan of the foot will be made). Therefore, the burden for
participants is considered minimal, with no significant health risks.
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
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
• 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
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 | NL83269.068.23 |