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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TERMINATED
33 participants
OBSERVATIONAL
2021-04-07
2024-03-16
Brief Summary
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Detailed Description
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The second group will be prospective and include patients who will receive the same total ankle replacement porous prosthesis but will be assigned to early 2 weeks post-operative weight-bearing protocol.The retrospective and prospective groups will be age and gender matched. A Wright Medical Infinity Total Ankle Replacement System will be used for both groups.
Both groups will be assessed at 1 year and 2 years post-operative. This assessment will take place during the post-operative care period and will be conducted as part of their post-operative care by the operating physician.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Retrospective 6 week Weight-Bearing
Delayed weight-bearing 6 weeks after total ankle replacement
No interventions assigned to this group
Prospective 2 week Weight-Bearing
Early weight-bearing 2 weeks after total ankle replacement
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Had delayed weight-bearing. Patients whose age and gender match the retrospective delayed weight-bearing group.
Exclusion Criteria
Patients who have had Total Ankle Replacement with subsequent development of deep infection requiring revision.
Patient who have had Total Ankle Replacement with subsequent development of Peri-prosthetic fractures during surgery or post-op.
18 Years
85 Years
ALL
Yes
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Amgaad Haleem, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma, Orthopedic Surgery
Locations
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OUPhysicians
Oklahoma City, Oklahoma, United States
Countries
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Other Identifiers
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12704
Identifier Type: -
Identifier Source: org_study_id
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