Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2002-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ankle Arthoplasty
Patients will undergo a Total Ankle Replacement procedure
Gait Analysis
A computerized motion analysis system to observe the effect of ankle arthroplasty versus ankle arthrodesis on the kinematic behaviour of the foot and ankle during gait.
Ankle fusion
Patients will undergo an Ankle Arthrodesis procedure
Gait Analysis
A computerized motion analysis system to observe the effect of ankle arthroplasty versus ankle arthrodesis on the kinematic behaviour of the foot and ankle during gait.
Interventions
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Gait Analysis
A computerized motion analysis system to observe the effect of ankle arthroplasty versus ankle arthrodesis on the kinematic behaviour of the foot and ankle during gait.
Eligibility Criteria
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Inclusion Criteria
2. Skeletal maturity
3. Able to give informed consent
Exclusion Criteria
2. Obesity (BMI \>30)
3. Prior Ankle fusion or arthroplasty
4. Active or prior infection within 12 months
5. Medical condition precluding major surgery
6. Severe ipsilateral mid or hind foot deformity
7. Severe osteoporotic or osteopenic bone
8. Neuromuscular impairment
9. Age less than 40 years old
10. Cognitive or psychiatric impairment prohibiting accurate follow-up
11. Pregnancy
12. Workers compensation board patients
40 Years
85 Years
ALL
No
Sponsors
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Johnson & Johnson
INDUSTRY
Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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Timothy R. Daniels, MD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Other Identifiers
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SMH 02-035
Identifier Type: -
Identifier Source: org_study_id