The aim of this study is to assess biomechanical properties after a calcaneal fracture, and compare these data tot the radiological and functional outcome parameters. Hereby comparing healthy subjects to patients who were treated with ORIF (open…
ID
Source
Brief title
Condition
- Bone and joint injuries
- Fractures
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To study the biomechanical and anatomical characteristics in patients treated
surgically after traumatic calcaneal fracture, and compare these data to
healthy subjects, patients after arthrodesis of the subtalar and talar joint.
- Is there a relation between the postoperative functional subtalar axis and
the clinical functional outcome?
- Is there a relation between the functional subtalar axis and the anatomical
subtalar axis?
Secondary outcome
To investigate whether the changes in biomechanical and anatomical
characteristics determines the post-operative outcome and patient satisfaction.
Research questions:
- What are the changes in biomechanics after surgery for calcaneal fractures if
compared to healthy persons?
- What are the changes in biomechanics after calcaneus surgery if compared to
patients after arthrodesis of the subtalar joint?
- What are the changes in biomechanics after calcaneus surgery if compared to
patients after arthrodesis of the talar joint?
- Does patient satisfaction after operative treatment correlate with changes in
biomechanics?
- Have the changes in biomechanics and difference in treatment an effect in the
patient satisfaction?
Background summary
In the Netherlands the number of patients that are treated in the emergency
room with an ankle- or foot injury is valued on approximately 190,000. The
fractures of the calcaneus comprise 60% of the tarsal fractures, but only 4% of
all foot-ankle fractures. The most common mechanism of injury is a high energy
axial load: fall from height.
The fractures can be treated conservatively or with ORIF (open reduction and
internal fixation). Functional outcome after conservative or ORIF is frequently
tampered. Improved understanding of biomechanical changes after calcaneal
fractures and surgery for calcaneal fractures may alter the functional outcome.
Study objective
The aim of this study is to assess biomechanical properties after a calcaneal
fracture, and compare these data tot the radiological and functional outcome
parameters. Hereby comparing healthy subjects to patients who were treated with
ORIF (open reduction internal fixation), with arthrodesis of the talar joint or
arthrodesis of the subtalar joint. The methods used for the assessment are the
VICON-system with the *Oxford foot model*, radiological characteristics
(computed tomography) and questionnaires. The VICON-system comprises of six
cameras and markers. The markers are placed on specific points on the subjects
with tape. The camera system then makes a recording and calculates specific
changes/vectors of the markers. By using this system the gait of the subject
can be analyzed and a comparison can be made between healthy and treated
subjects. The outcome of this part of the investigation is to assess the
biomechanical changes of the ankle-joint and to determine the *subtalar
joint-axis* (STJ-axis).
The VICON system is validated for the testing of the lower extremity in
combination with other programs, the oxford foot model has been validated by
other authors. This system has been used in multiple trials by the department
of movement sciences of Maastricht University, but previsously not regarding
the STJ-axis. Recently, the department of movement sciences has validated with
the VICON-system the Oxford foot model.
Earlier investigations have given us more insight in the relationship between
the function of the ankle-joint and the STJ-axis. It is known that this axis,
between the calcaneal bone and the talus bone, has great influence on the
function of the ankle.
The aim of this study is to determine the influence of deviations in the
STJ-axis on the (postoperative) outcome.
Also there will be a footprint-analysis to get an impression of the pressure
partitioning.
The outcomes of the biomechanical analyses are compared in the patients group
with the radiological findings on CT (Böhler, Ghislaine angle, subtalar joint
congruency). Furthermore the patients* satisfaction is analyzed by health
questionnaires (The foot and ankle disability score (FADI), Visual Analog Scale
of Hildebrand and RAND-36).
By analyzing these outcomes there can be overall, objective, assessment of the
postoperative outcome after the trauma ankle-surgery. At present there is no
evidence comparing biomechanical analyses of the VICON-system with radiological
and patient reported outcome scores. The outcome of this study can contribute
in the knowledge about the foot biomechanics and the decision for the treatment
of a calcaneal fracture. Intra-operative pedobarography has been shown to
improve outcome in patients undergoing ankle arthrodesis and may be also
applicable in acute fracture surgery.
Study design
The experimental design of the study is a prospective observational study
comparing healthy and operated patients regarding foot biomechanical and
anatomical abnormalities, and outcome satisfaction.
Study burden and risks
There will be no benefits or extra risks for the participants during this
study.
P. Debyelaan 25
6202 AZ
NL
P. Debyelaan 25
6202 AZ
NL
Listed location countries
Age
Inclusion criteria
Group 1: Primary (non-pathological) displaced unilateral fracture of the calcaneus (open fractures are included)
1. Age: 18-65 years old
2. Independent for activities of daily living (yes/no question).
3. All patients must be >1 year after operation/fracture;Group 2: Healthy subjects
1. Age: 18-65 years old
2. Independent for activities of daily living (yes/no question).;Group 3: Patients after subtalar arthrodesis for posterior facet posttraumatic arthritis
1. Age: 18-65 years old
2. Independent for activities of daily living (yes/no question).
3. All patients must be >1 year after operation/fracture;Group 4: Patients after talar arthrodesis for posttraumatic arthritis of the ankle joint, with no signs of subtalar arthritis
1. Age: 18-65 years old
2. Independent for activities of daily living (yes/no question).
3. All patients must be >1 year after operation/fracture
Exclusion criteria
Group 1: Primary (non-pathological) displaced unilateral fracture of the calcaneus (open fractures are included)
1. Fracture of contra lateral leg/ankle
2. Neurotrauma
3. Spinal or neurological injury
4. Pathologic fractures (metastasis, secondary osteoporosis)
5. Dependent in activities of daily living.;Group 2: Healthy subjects
1. History of operations or fractures of the legs.
2. Dependent in activities of daily living.;Group 3: Patients after subtalar arthrodesis for posterior facet posttraumatic arthritis
1. Fracture of contra lateral leg/ankle
2. Neurotrauma
3. Spinal or neurological injury
4. Pathologic fractures (metastasis, secondary osteoporosis)
5. Dependent in activities of daily living.;Group 4: Patients after talar arthrodesis for posttraumatic arthritis of the ankle joint, with no signs of subtalar arthritis
1. Fracture of contra lateral leg/ankle
2. Neurotrauma
3. Spinal or neurological injury
4. Pathologic fractures (metastasis, secondary osteoporosis)
5. Dependent in activities of daily living.
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 | NL34131.068.10 |