3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Arthroplasty
Stopped early
Conditions studied: Ankle Arthroplasty, Prosthesis User, Joint Disease
In brief
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.
Key facts
- Study ID
- NCT03575975
- Run by
- Georgia Institute of Technology
- People needed
- 9
- Starts
- 2018-05-30
- Expected to finish
- 2020-04-16
- Last updated by the study team
- 2021-05-28
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.)
You may not qualify if…
- 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
Where it is running
- Georgia Institute of Technology — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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