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FACTS study: Functional outcome assessment after Calcaneal Trauma Surgery

Recruiting
Conditions
calcaneal break
calcaneusfracture
10005942
10017322
10005944
Registration Number
NL-OMON34227
Lead Sponsor
Medisch Universitair Ziekenhuis Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
36
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.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>To study the biomechanical and anatomical characteristics in patients treated<br /><br>surgically after traumatic calcaneal fracture, and compare these data to<br /><br>healthy subjects, patients after arthrodesis of the subtalar and talar joint.<br /><br>- Is there a relation between the postoperative functional subtalar axis and<br /><br>the clinical functional outcome?<br /><br>- Is there a relation between the functional subtalar axis and the anatomical<br /><br>subtalar axis?</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>To investigate whether the changes in biomechanical and anatomical<br /><br>characteristics determines the post-operative outcome and patient satisfaction.<br /><br><br /><br>Research questions:<br /><br>- What are the changes in biomechanics after surgery for calcaneal fractures if<br /><br>compared to healthy persons?<br /><br>- What are the changes in biomechanics after calcaneus surgery if compared to<br /><br>patients after arthrodesis of the subtalar joint?<br /><br>- What are the changes in biomechanics after calcaneus surgery if compared to<br /><br>patients after arthrodesis of the talar joint?<br /><br>- Does patient satisfaction after operative treatment correlate with changes in<br /><br>biomechanics?<br /><br>- Have the changes in biomechanics and difference in treatment an effect in the<br /><br>patient satisfaction?</p><br>
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