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FACTS study: Functional outcome assessment after Calcaneal Trauma Surgery

FACTS study: Functional outcome assessment after Calcaneal Trauma Surgery - FACTS-study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34227
Enrollment
36
Registered
2010-12-06
Start date
2011-02-10
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

calcaneal break calcaneusfracture

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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?

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)