Prosthesis User Clinical Trial
Official title:
3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Replacement With Stryker STAR Implant
Verified date | May 2021 |
Source | Georgia Institute of Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Patients who have had a total ankle joint replacement surgery typically have limited movement in their ankles possibly due to the fact that commonly used ankle joint prosthetic devices only allow limited axes of motion. This study will evaluate the ability of a Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis and INBONE 2 fixed-bearing prosthesis to restore triplanar motion in the tibiotalar (ankle) joint following a surgical arthroplasty (total joint replacement) procedure. 3D X-ray video motion analysis will be utilized to quantify range of motion measurements in two groups of ankle prosthesis users and a group of matched control participants.
Status | Terminated |
Enrollment | 9 |
Est. completion date | April 16, 2020 |
Est. primary completion date | April 16, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility | INCLUSION CRITERIA: - Between 18 to 79 years of age. Additional Inclusion criteria for mobile-bearing ankle prosthesis user group: - Able to walk independently with their prosthesis at different self-selected speeds - Implanted with Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis at least one year prior to enrollment - Pain free and radiologically normal - Able to walk at preferred walking speed without an assistive device (e.g., cane, crutches, etc.) Additional Inclusion criteria for control group: - Within 3 years of age of one of the mobile-bearing ankle prosthesis user participants - Same gender as the matched mobile-bearing ankle prosthesis user participant - Not have a history of major musculoskeletal injuries - Not have a history of major neuromuscular injuries Additional Inclusion criteria for fixed-bearing ankle prosthesis users: - Able to walk independently with their prosthesis at different self-selected speeds - Implanted with INBONE 2 prosthesis at least one year prior to enrollment - Pain free and radiologically normal - Able to walk at preferred walking speed without an assistive device (cane, crutches, etc.) EXCLUSION CRITERIA: - Have dementia or an inability to give informed consent - Have significant or chronic loss of hip or knee joint motion - Have any subtalar or hindfoot fusion - Have a history of dizziness and/or balance problems - Have had any additional x-ray exposures in the past year that would put beyond the recommended annual dose for the study - Are pregnant - Exhibit evidence of polysubsidence (implant loosening) - Exhibit evidence of a broken implant |
Country | Name | City | State |
---|---|---|---|
United States | Georgia Institute of Technology | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Georgia Institute of Technology | Emory University, Stryker Orthopaedics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tibiotalar Joint Angle Kinematics | 3D range of motions of the tibiotalar (upper ankle) joint were recorded and analyzed using a biplanar x-ray motion analysis system. In particular, joint ranges of motion were tested in terms of dorsiflexion-plantarflexion, internal-external rotation, and inversion-eversion angles. | 1 year | |
Secondary | Tibiotalar Joint Linear Translation Kinematics | 3D range of linear motions of the tibiotalar (upper ankle) joint were recorded and analyzed using a biplanar x-ray motion analysis system. In particular, linear joint ranges of motion were tested in terms of the anteroposterior, mediolateral, and superior-inferior axes. | 1 year |
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